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[COMMITTEE PRINT]

LEGISLATIVE HISTORY OF THE TOXIC
SUBSTANCES CONTROL ACT

TOGETHER WITH

A SECTION-BY-SECTION INDEX

PREPARED BY THE

EXVIROXMEXT AXD XATURAL RESOUECES
POLICY DIVISIOX

OF THE

LIBRARY OF COXGRESS

FOR THE

HOUSE COMMITTEE ON
INTERSTATE AND FOREIGN COMMERCE

DECEMBER 1976

Printed for the use of the
Committee on Interstate and Foreign Commerce

79-313 o

U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 1976

COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE

HARLEY O. STAGGERS,
JOHN E. MOSS, California
JOHN D. DINGELL, Michigan
PAUL G. ROGERS, Florida
LIONEL VAN DEERLIN, California
FRED B. ROONEY, Pennsylvania
JOHN M. MURPHY, New York
DAVID E. SATTERFIELD III, Virginia
BROCK ADAMS, Washington
W. S. (BILL) STUCKEY, Jr., Georgia
BOB ECKHARDT, Texas
RICHARDSON PREYER, North Carolina
JAMES W. SYMINGTON, Missouri
CHARLES J. CARNEY, Ohio
RALPH H. METCALFE, Illinois
GOODLOE E. BYRON, Maryland
JAMES H. SCHEUER, New York
RICHARD L. OTTINGER, New York
HENRY A. WAXMAN, California
ROBERT (BOB) KRUEGER, Texas
TIMOTHY E. WIRTH, Colorado
PHILIP R. SHARP, Indiana
WILLIAM M. BRODHEAD, Michigan
JAMES J. FLORIO, New Jersey
ANTHONY TOBY MOFFETT, Connecticut
JIM SANTINI, Nevada
ANDREW MAGUIRE, New Jersey
MARTIN A. RUSSO, Illinois

West Virginia, Chairman

SAMUEL L. DEVINE, Ohio

JAMES T. BROYHILL, North Carolina

TIM LEE CARTER, Kentucky

CLARENCE J. BROWN, Ohio

JOE SKUBITZ, Kansas

JAMES M. COLLINS, Texas

LOUIS PREY, Jr., Florida

JOHN Y. McCOLLISTER, Nebraska

NORMAN F. LENT, New York

H. JOHN HEINZ III, Pennsylvania

EDWARD R. MADIGAN, Illinois

CARLOS J. MOORHEAD, California

MATTHEW J. RINALDO, New Jersey

W. HENSON MOORE, Louisiana

W. E. Williamson, Clerk
Kenneth J. Painter, Assistant Clerk

Professional Staff

Charles B. Curtis
Lee S. Hyde
Elizabeth Harrison
Jeffrey H. Schwartz

Margot Dinneen
Lewis E. Berry, Minority Counsel

William P. Adams
Robert R. Nordhaus
Brian R. Moir
Karen Nelson

LETTER OF TRANSMITTAL

The Library of Coxgress,
Congressional Research Service,
Washington^ D.C., November 15^ 1976.

Hon. PLvRLEY O. Staggers,

Chainnaru Committee on Interstate ami Foreign Commerce^ U.S.
House of Represe7itatives^ Washington^ B.C.
Dear ^Ir. Chairman : In response to your request, we liave prepared
a legislative history of the Toxic Substances Control Act, Public Law
94-469.

This docuinorit contains the major bills, reports, and debates which
comprise the action of the 94th Congress concerning the act. Appen-
dices contain a report of the (^ouncil on P^nvironmental Quality which
originally proposed this legislation and a bibliography of Congres-
sional documents concerning Toxic Substances Control legislation
from 1971 to 1976. A section-by-section index is included to permit
easier access to provisions of concern.

The history should be of considerable aid to legislatoi*s, public offi-
cials, industries, and the general public who are affectx^d by this act
and who wish to understand the Congressional intent of Public Law
94-469.

The author of this report was John E. Plodgett, Analyst, of tlie
Environment and Natural Resources Policy Division.

We hope this document will serve your Committee's needs for a his-
tory of Congressional action on this act.
Sincerely,

Norman Beckman,

Acting Director.

(Ill)

FOREWORD

This committee print compiles the siofnificant documents and de-
bates comprisintr the legislative history of S. 3149, the Toxic Sub-
stances Control Act. signed into law (Public Law 94-^69) on Octo-
ber 11, 1976.

Congressional activity concerning this act extends back to 1971,
when the Council on Environmental Quality published a report "Toxic
Substances." This report is reprinted as an appendix. The major Con-
gressional documents and debates of the full ])eriod of action on toxic
substances control — 1971 to 1976 — are listed in the bibliography.

In the debates, references to specific sections are in boldface type;
these refer to the section numbers of the bill under consideration. A
table at the beginning of the index correlates the section numbers of
the major bills and of the act (all of which are identical except for the
last few sections).

Joiix E. Blodgett,
Analysts En vironmenf and Xafural

Resources Policy Division.

(V)

Digitized

by the Internet Archive

n2013

http://archive.org/details/leehistoOOunit

CONTENTS

Page

Chapter I : Toxic Substances Control Act 2

Public Law 94-469 3

President's approval 53

Chapter II : S. 3149 55

S. 3149 57

Senate Report No. 94-698 155

Senate debate, March 26, 1976 207

Chapter III: H.R. 14032 295

H.R. 14032 297

House Report No. 94-1341 407

House debate, Aujjust 23. 1976 517

Chapter IV : Conference Report 665

Conference report. House Report No. 94-1679 667

Senate consideration of conference report, September 28, 1976 721

House consideration of conference reiMirt. September 28, 1976 741

Appendix I : Council on KInvironmental Quality report — Toxic Suhfitanccs

(1971) 755

Appendix II : Bibliography — Congressional documents 1971-1970 789

Section-by-section index :

Table comparing? sections of Public Law 94—169, H.R. 14032, and

S. 3149 795

Index 795

(vn)

CHAPTER I

TOXIC substancp:s control act-
public LAW 94-469

PUBLIC LAW 94-^9— OCT. 11, 1976 90 STAT. 2003

Public Law 94-469
94th Congress ,

An Act

To regulate commerce and protect human health and the environment by Oct. 11, 1976
requiring testing and necessary use restrictions on certain chemical substances, rg 31 401

and for other purposes. ^ ' ^

Be it enacted hy the Senate and Ilouae of Representatives of the
Unitt d States of Arntrh a in Congress assembled^ Toxic Substances

SECTION 1. SHORT TITLE AND TABLE OF CONTENTS. irUSC 2^)^

This Act may be cited as the "Toxic Substances Control Act". note.

TABLE OF CONTENTS

Sec, 1. Short title and table of contents.
Sec. 2. Findings, policy, and intent.
Sec. 3. Definitions.

Sei*. 4. Testing of diemical substances and mixtures.
Sec. 5. Manufacturing and i)rocessing notices.

Se<-. 6. Reguhition of hazardoiis chemical substances and mixtures.
Sec. 7. Imminent hazards.

Sec. 8. Reporting and retention of information.
Sec. 9. Relationship to other Federal laws.

Sec. 10. Research, deveh)pment, collection, dissemination, and utilization of data.
Sec. 11. Inspections and subpoenas.
Sec. VI. Exports.

Sec. 13. Entry into customs territory of the United States.
Sec. 14. Di.^dosure of data.
Sec. 15. Prohibited acts.
Sec. 16. Penalties.

Sec. 17. Specific enforcement and seizure.

Sec. 18. I'reemption.

Se<'. 19. Judicial review.

Sec. 20. Citizens' civil actions.

Sec. 21. Citizens' petitions.

Sec. 22. National defense waiver.

Sec. 23. Employee protection.

Sec. 24. Employment effects.

Sec. 25. Studies.

Sec. 26. Administration of the Act.

Sec. 27. Development and evaluation of test methods.

Sec. 28. State programs.

Sec. 29. Authorization for appropriations.

Sec. 30. Annual report.

Sec. 31. Effective date.

SEC. 2. FINDINGS, POLICY, AND INTENT.

(a) Findings.— The Congress finds tliat— 15 USC 2601.

(1) human beings and the environment are being exposed each
year to a large number of chemical substances and mixtures;

(2) among the many chemical substances and mixtures which
are constantly being developed and produced, there are some
whose manufacture, processing, distribution in commerce, use, or
disposal may present an unreasonable risk of injury to health or
the environment; and

(3) the effective regulation of interstate commerce in such
chemical substances and mixtures also necessitates the regulation
of intrastate commerce in such chemical substances and mixtures.

(b) Policy. — It is the policy of the United States that —

(1) adequate data should be developed with respect to the effect
of chemical substances and mixtures on health and the environ-

90 STAT. 2004 PUBLIC LAW 94-469— OCT. 11, 1976

ment and that the development of such data should be the respon-
sibility of those who manufacture and those who process such
chemical substances and mixtures ;

(2) adequate authority should exist to regulate chemical sub-
stances and mixtures which present an unreasonable risk of injury
to health or the environment, and to take action with respect to
chemical substances and mixtures which are imminent hazards;
and

(3) authority over chemical substances and mixtures should be
exercised in such a manner as not to impede unduly or create
unnecessary economic barriei-s to technological innovation wliile
fulfilling the primary purpose of this Act to assure that such inno- .
vation and commerce in such chemical substances and mixtures
do not present an unreasonable risk of injury to health or the
environment.

(c) Intent of Congress. — It is the intent of Congress that the
Administrator shall carry out this Act in a reasonable and prudent
manner, and that the Administrator shall consider the environmental,
economic, and social impact of any action the Administrator takes or
proposes to take under this Act.
SEC. 3. DEFINITIONS.
15 use 2602. As used in this Act:

(1) the term "Administrator" means the Administrator of the
Environmental Protection Agency.

(2) (A) Except as provided in subparagraph (B), the term "chem-
ical substance" means any organic or morganic substance of a particu-
lar molecular identity, including —

(i) any combination of such substances occurring in whole or
in part as a result of a chemical reaction or occurring ki nature,
and

(ii) any element or uncombined radical.
( B ) Such term does not include —

(i) any mixture,

(ii) any pesticide (as defined in the Federal Insecticide, Fungi-
7 use 136 note. cide, and Rodenticide Act) when manufactured, processed, or

distributed in commerce for use as a pesticide,

(iii) tobacco or any tobacco product,

(iv) any source material, special nuclear material, or byproduct
material (as such terms are defined in the Atomic Energy Act

42 use 2011 of 1954 and regulations issued under such Act),

°ot«- (v) any article the sale of which is subject to the tax imposed

26 use 4181. by section 4181 of the Internal Revenue Code of 1954 (deter-

mined without regard to any exemptions from such tax provided
26 use 4182, by section 4182 or 4221 or any other provision of such Code) , and

"^221. (vi) any food, food additive, drug, cosmetic, or device (as such

terms are defined in section 201 of the Federal Food, Drug, and
21 use 321. Cosmetic Act) when manufactured, processed, or distributed in

commerce for use as a food, food additive, drug, cosmetic, or
device.

The term "food" as used in clause (vi) of tliis subparagraph includes
poultry and poultry products (as defined in sections 4(e) and 4(f)
21 use 453. of the Poultry Products Inspection Act) , meat and meat food prod-
21 use 601. ucts (as defined in section of the Federal Meat Inspection Act),
and eggs and egg products (as defined in section 4 of the Egg Prod-
21 use 1033. ucts Insnection Act) .

(3) The term "commerce" means trade, traffic, transportation, or
other commerce (A) between a place in a State and any place outside

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2005

of sucli State, or (B) which affects trade, traffic, transportation, or
commerce described in clause ( A) .

(4) The terms "distribute in commerce'* and "distribution in com-
merce" when used to describe an action taken with respect to a chem-
ical substance or mixture or article containing a substance or mixture
mean to sell, or the sale of, the substance, mixture, or article in com-
merce ; to introduce or deliver for introduction into commerce, or the
introduction or delivery for introduction into commerce of, the sub-
stance, mixture, or article ; or to hold, or the holding of, the substance,
mixture, or article after its introduction into commerce.

(5) The term "environment" includes water, air, and land and the
interrelationship which exists among and between w^ater, air, and land
and all living things.

(6) The tenn "health and safety study" means any study of any
effect of a chemical substance or mixture on health or the environ-
ment or on both, including underlying data and epidemiological
studies, studies of occupational exposure to a chemical substance or
mixture, toxicological, clinical, and ecological studies of a chemical
substance or mixture, and any test performed pursuant to this Act.

(7) The term 'Snanufacture" means to import into the customs
territory of the United States (as defined in general headnote 2 of

the Tariff Schedules of the United States), prepuce, or manufacture. 19 USC 1202.

(8) The term "mixture" means any combination of two or more
chemical substances if the combination does not occur in nature and
is not, in whole or in part, the result of a chemical reaction ; except
that such term does include any combination which occurs, in whole
or in part, as a result of a chemical reaction if none of the chemical
substances comprising the combination is a new chemical substance
and if the combination could have been manufactured for commer-
cial purposes without a chemical reaction at the time the chemical
substances comprising the combination were combined.

(9) The term "new chemical substance" means any chemical sub-
stance which is not included in the chemical substance list compiled

and published under section 8(b). Post, p. 2027.

(10) The term "process" means the preparation of a chemical sub-
stance or mixture, after its manufacture, for distribution in
commerce —

(A) in the same form or physical state as, or in a different
form or physical state from, that in which it was received by the
person so preparing such substance or mixture, or

(B) as part of an article containing the chemical substance
or mixture.

(11) The term "processor" means any person who processes a chemi-
cal substance or mixture.

(12) The term "standards for the development of test data" means
a prescription of —

(A) the—

(i) health and environmental effects, and

(ii) information relating to toxicity, persistence, and other
characteristics which affect health and the environment,

for which test data for a chemical substance or mixture are to
be developed and any analysis that is to be performed on such
data, and

(B) to the extent necessary to assure that data respecting such
effects and characteristics are reliable and adequate —

(i) the manner in which such data are to be developed,

(ii) the specification of any. test protocol or methodology
to be employed in the development of such data, and

90 STAT. 2006

PUBUC LAW 94^469— OCT. 11, 1976

15 use 2603.

Rules.

Standards for
development of
test data.
Data, submittal to
Administrator.

(iii) such other requirements as are necessary to provide
such assurance.

(13) The term "State" means any State of the United States, the
District of Columbia, the Commonwealth of Pueiix) Rico, the Virgin
Islands, Guam, the Canal Zone, American Samoa, the Northern
Mariana Islands, or any other territory or possession of the United
States.

(14) The term "United States", when used in the geographic sense,
means all of the States.

SEC. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES.

(a) Testing Requirements. — If the Administrator finds that —

(1) (A)(i) the manufacture, distribution in commerce, proc-
essing, use, or disposal of a chemical substance or mixture, or that
any combination of such activities, may present an unreasonable
ri k of injury to health or the environment,

(ii) there are insufficient data and experience upon which the
effects of such manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combina-
tion of such activities on health or the environment can reason-
ably be determined or predicted, and

(iii) testing of such substance or mixture with respect to such
effects is necessary to develop such data ; or

(B) (i) a chemical substance or mixture is or will be produced
in substantial quantities, and (I) it enters or may reasonably be
anticipated to enter the environment in substantial quantities or
(II) there is or may be significant or substantial human exposure
to such substance or mixture,

(ii) there are insufficient data and experience upon which the
effects of the manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combina-
tion of such activities on health or the environment can reason-
ably be determined or predicted, and

(iii) testing of such substance or mixture with respect to such
effects is necessary to develop such data ; and

(2) in the case of a mixture, the effects which the mixture's
manufacture, distribution in commerce, processing, use, or dis-
posal or any combination of such activities may have on health or
the environment may not be reasonably and more efficiently deter-
mined or predicted by testing the chemical substances which com-
prise the mixture ;

the Administrator shall by rule require that testing be conducted on
such substance or mixture to develop data with respect to the health
and environmental effects for which there is an insufficiency of data
and experience and which are relevant to a determination that the
manufacture, distribution in commerce, processing, use, or disposal
of such substance or mixture, or that any combination of such activities,
does or does not present an unreasonable risk of injury to health or
the environment.

(b) (1) Testing Requirement Rule. — A rule under subsection (a)
shall include —

(A) identification of the chemical substance or mixture for
which testing is reauired under the rule,

(B) standards for the development of test data for such sub-
stance or mixture, and

(C) with respect to chemical substances which are not new
chemical substances and to mixtures, a specification or the period
(which period may not be of unreasonable duration) within

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2007

which the persons required to conduct the testing shall submit to
the Administrator data developed in accordance with the stand-
ards referred to in subparagraph (B).
In determining the standards and period to be included, pursuant to
subparagraphs (B) and (C), ^n a rule under subsection (a), the
Administrator's considerations shall include the relative costs of the
various test protocols and methodologies which ma^' be required under
the rule and the reasonably foreseeable availability of the facilities
and personnel needed to perform the testing required under the rule.
Any such rule may require the submission to the Administrator of pre-
liminary data during the period prescribed under subparagraph (C).

(2) (A) The health ana environmental effects for which standards
for the development of test data may be prescribed include carcino-
genesis, mutagenesis, teratogenesis, behavioral disorders, cumulative
or synergistic effects, and any other effect which may present an unrea-
sonable risk of injury to health or the environment. The chai-acteristics
of chemical substances and mixtures for which such standanls may
be prescribed include persistence, acute toxicity, subacute toxicity,
chronic toxicity, and any other characteristic which may present such
a risk. The methodologies that may be prescribed in such standards
include epidemiologic studies, serial or hierarchical tests, in vitro tests,
and whole animal tests, except that before prescribing epidemiologic
studies of employees, the Administrator shall consult with the Director
of the National Institute for Occupational Safety and Health.

(B) From time to time, but not less than once each 12 months, the Review of
Administrator shall review the adequacy of the standards for develop- standards,
ment of data prescribed in rules under subsection (a) and shall, if
necessary, institute proceedings to make appropriate revisions of such
standards.

(3) (A) A rule under subsection (a) respecting a chemical substance
or mixture shall require the })ersons described in subparagraph (B)
to conduct tests and submit data to the Administrator on such sub-
stance or mixture, except that the Administrator may permit two or
more of such })ei-sons to designate one such pei-son or a qualified ihiixi
party to conduct such tests and submit such data on behalf of the per-
sons making the designation.

(B) The following i>ersons shall be required to conduct tests and
submit data on a chemical substance or mixture subject to a rule under
subsection (a) :

(i) Each person who manufactures or intends to manufacture
such substance or mixture if the Administrator makes a finding
described in subsection (a) (1) (A) (ii) or (a) (1) (B) (ii) with
respect to the manufacture of such substance or mixture.

(ii) Each person who processes or intends to process such sub-
stance or mixture if the Administrator makes a finding described
in subsection (a) (1) (A) (ii) or (a) (1) (B) (ii) with respect to
the processing of such substance or mixture.

(iii) Each person who manufactures or processes or intends to
manufacture or process such substance or mixture if the Adminis-
trator makes a nnding described in subsection (a) (1) (A) (ii) or
(a) (1) (B) (ii) with respect to the distribution in commerce, use,
or disposal of such substance or mixture.

(4) Any rule under subsection (a) requiring the testing of and
submission of data for a particular chemical substance or mixture
shall expire at the end of the reimbursement period (as defined in sub-
section (c)(3)(B)) which is applicable to test data for such substance
or mixture unless the Administrator repeals the rule before such date;

90 STAT. 2008

PUBUC LAW 94-469— OCT. 11, 1976

Oral presentatioi
and written
submissions.
TranscripL
Publication.

Application.

Fair and
equitable
reimbursement

Rules.

and a rule under subsection (a) requiring the testing of and submission
of data for a category of chemical substances or mixtures shall expire
with respect to a chemical substance or mixture included in the cate-
gory at the end of the reimbursement period (as so defined) which is
applicable to test data for such substance or mixture unless the Admin-
istrator before such date repeals the application of the rule to such
substance or mixture or repeals the rule.

(5) Rules issued under subsection (a) (and any substantive amend-
ment thereto or repeal thereof) shall be promulgated pursuant to
section 553 of title 5, United States Code, except that (A) the Admin-
istrator sliall give interested persons an opportunity for the oral pres-
entation of data, views, or arguments, in addition to an opportunity to
make written submissions; (B) a transcript shall be made of any oral
presentation; and (C) the Administrator shall make and publish with
the rule the findings described in paragraph (1) (A) or (1)(B) of
subsection (a) and, in the case of a rule respecting a mixture, the
finding described in paragraph (2) of such subsection.

(c) Exemption. — (1) Any person required by a rule under subsec-
tion (a) to conduct tests and submit data on a chemical substance or
mixture may apply to the Administrator (in such form and manner
as the Administrator shall prescribe for an exemption from such
requirement.

(2) If, upon receipt of an application under paragraph (1), the
Administrator determines that —

(A) the chemical substance or mixture with respect to which
such application was submitted is equivalent to a chemical sub-
stance or mixture for which data has been submitted to the Admin-
istrator in accordance with a rule under subsection (a) or for
which data is being developed pursuant to such a rule, and

(B) submission of data by the applicant on such substance or
mixture would be duplicative of data which has been submitted
to the Administrator in accordance with such rule or which is
being developed pursuant to such rule,

the Administrator shall exempt, in accordance with paragraph (3)
or (4), the applicant from conducting te^ts and submitting data on
such substance or mixture under the rule with respect to which such
application was submitted.

(3) (A) If the exemption under paragraph (2) of any person from
the requirement to conduct tests and submit t^t data on a chemical
substance or mixture is granted on the basis of the existence of previ-
ouslv submitted test data and if such exemption is granted during the
reimbursement period for such test data (as prescribed by subpara-
graph (B) ), then (unless such person and the persons referred to in
clauses (i) and (ii) agree on the amount and method of 'reimburse-
ment) the Administrator shall order the person granted the exemption
to provide fair and equitable reimbursement (in an amount deter-
mined under rules of the Administrator ) —

(i) to the person who previously submitted sUch test data, for
a portion of the costs incurred by such person i^ complying with
the requirement to submit such data, and

(ii) to any other person who h^ been required under this sub-
paragraph to contribute with respect to such costs, for a portion
of the amount such person was required to contribute.

PUBLIC LAW 94^9— OCT. 11, 1976 90 STAT. 2009

and the Federal Trade Commission, consider all relevant factors,
including the effect on the competitive position of the person required
to provide reimbursement in relation to the person to be reimbursed
and the share of the market for such substance or mixture of the per-
son required to provide reimbursement in relation to the share of such
market of the persons to be reimbursed. An order under this sub-
paragraph shall, for purposes of judicial review, be considered final
agency action.

(B) For purposes of subparagraph (A), the reimbursement period Reimbursement
for any test data for a chemical substance or mixture is a perioa — period.

(i) beginning on the date such data is submitted in accordance
with a rule promulgated under subsection (a) , and

(ii) ending —

(I) five years after the date referred to in clause (i), or

(II) at the expiration of a period which begins on the date
referred to in clause (i) and which is equal to the period
which the Administrator determines was necessary to develop
such data,

whichever is later.
(4) (A) If the exemption under paragraph (2) of any person from
the requirement to conduct tests and submit test data on a chemical
substance or mixture is granted on the basis of the fact that test data
is being developed by one or more persons pursuant to a rule promul-
gated under subsection (a), then (unless such person and the persons
referred to in clauses (i) and (ii) agree on the amount and method
of reimbursement) the Administrator shall order the person granted
the exemption to provide fair and equitable reimbursement (in an
amount determined under rules of the Administrator) —

(i) to each such person who is developing such test data, for a
portion of the costs incurred by each such person in cx)mplying
with such rule, and

(ii) to any other person who has been required under this sub-
paragraph to contribute with respect to the costs of complying
with such rule, for a portion of the amoimt such person was
required to contribute.

In promulgating rules for the determination of fair and eauitable
reimbursement to the persons described in clauses (i) and (ii) for
costs incurred with respect to a chemical substance or mixture, the
Administrator shall, after consultation with the Attorney General and
the Federal Trade Commission, consider the factors described in the
second sentence of paragraph (3) (A). An order under this subpara-
graph shall, for purposes of judicial review, be considered final agency
action.

(B) If any exemption is granted under paragraph (2) on the basis
of the fact that one or more persons are developing test data pursuant
to a rule promulgated under subsection (a) and if after such exemp-
tion is granted the Administrator determines that no such person has
complied with such rule, the Administrator shall (i) after providing
written notice to the person who holds such exemption and an oppor-
tunity for a hearing, by order terminate such exemption, and (ii)
notify in writing such person of the requirements of the rule with
respect to which such exemption was granted.

(d) Notice. — Upon the receipt of any test data pursuant to a rule Publication in
under subsection (a), the Administrator shall publish a notice of the Federal Register,
receipt of such data in the Federal Register within 15 days of its
receipt. Subject to section 14, each such notice shall (1) identify the
chemical substance or mixture for which data have been received;
(2) list the uses or intended uses of such substance or mixture and the

79-313 O - 77 - 2

90 STAT. 2010

PUBLIC LAW 94-469— OCT. 11, 1976

Post, p. 2034.

Committee to
make

recommendations
to

Administrator.

Recommenda-
tions, list of
chemical
substances and
mixtures.

Publication in
Federal Register;
transmitt^^ to
Administrator.

List revision,
publication in
Federal Register.

inforination required by the applicable standards for the development
of test data; and (3) describe the nature of the test data developed.
Except as otherwise provided in section 14, such data shall be made
available by the Administrator for examination by any person.

(e) Priority List. — (1) (A) There is established a committee to
make recommendations to the Administrator respecting the chemical
substances and mixtures to which tlie Administrator should give
priority consideration for the promulgation of a rule under subsec-
tion (a). In making such a recommendation with respect to any chem-
ical substance or mixture, the committee shall consider all relevant
factors, including —

(i) the quantities in which the substanceior mixture is or will
be manufactured,

(ii) the quantities in which the substance or mixture enters or
will enter the environment,

(iii) the number of individuals who are or will be exposed to the
substance or mixture in their places of employment and the dura-
tion of such exposure,

(iv) the extent to which human beings are or will be exposed to
the substance or mixture,

(v) the extent to which the substance or mixture is closely
related to a cliemical substance or mixture which is known to
present an unieasonable risk of injury to health or the environ-
ment,

(vi) the existence of data concerning the effects of the substance
or mixture on health or. the environment,

(vii) the extent to which testing of the substance or mixture
may result in the development of data upon which the effects of
the substance or mixture on health or the environment ^an rea-
sonably be determined or predicted, and

(viii) the reasonably foreseeable availability of facilities and
personnel for performing testing on the substance or mixture.

The recommendations of the committee shall be in the form of a list
of chemical substances and mixtures which shall be set forth, either by
individual substance or mixture or by groups of substances or mix-
tures, in the order in which the committee determines the Administra-
tor should take action under subsection (a) with respect to the
substances and mixtures. In establishing such list, the committee shall
give priority attention to those chemical substances and mixtur
which are known to cause or contribute to or which are suspected
causing or contributing to cancer, gene mutations, or birth defects. The
committee shall designate chemical substances and mixtures onj^Ke list
with respect to which the committee determines the Administrator
should, within 12 months of the date on which such substances and
mixtures are first designated, initiate a proceeding under subsection
(a). The total number of chemical substances and mixtures on the list
which are designated under the preceding sentence may not, at any
time, exceed .50.

(B) As soon as practicable but not later than nine months after
the effective date of this Act, the connnittee shall publish in the Fed-
eral Register and transmit to the Administrator the list and designa-
tions required by subparagraph (A) together with the reasons for the
committee's inclusion of each chemical substance or mixture on the list.
At least every six months after the date of the transmission to the Ad-
ministrator (if the list pursuant to the precoeding sentence, the commit-
tee shall make such revisions in the list as it determines to be ne<:essary
and shall transmit them to the Administrator together witli the com-
mittee's reasons for the revisions. Upon receipt of any such revision,

PUBLIC LAW 94-469— OCT. 11, 1976

90 STAT. 2011

the Administrator shall publish in the Federal Register the list with
such revision, the reasons for such revision, and the designations made
under subparagraph ( A) . The Administrator shall provide reasonable Comments,
opportunity to any interested person to file with the Administrator
written comments on the committee's list, any revision of such list
by the committee, and designations made by the committee, and shall
make such comments available to the public. Within the 12-month Publication in
period beginning on the date of the first inclusion on the list of a Federal Register,
chemical substance or mixture designated by the committee under sub-
paragraph (A) the Administrator shall with respect to such chemical
substance or mixture either initiate a rulemaking proceeding under
subsection (a) or if such a proceeding is not initiated within such
period, publish in the Federal Register the Administrator's reason for
not initiating such a proceeding.

(2) (A) The committee established by paragraph (1) (A) shall con- Membership,
sist of eight membei"S as follows :

(i) One member appointed by the Administrator from the
Environmental Protection Agency.

(ii) One member appointed by the Secretary of Labor from
officers or employees of the Department of I^bor engaged in the
Secretary's activities under the Occupational Safety and Health
Act of 1970.

(iii) One member appointed by the Chairman of the Council
on Environmental Quality from, the Council or its officer's or

(iv) One member appointed by the Director of the National
Institute for Occupational Safety and Health from officers or
employees of the Institute.

(v) One member appointed by the Director of the National
Institute of Environmental Health Sciences from officers or
employees of the Institute.

(vi) One member appointed by the Director of the National
Cancer Institute from officers or employees of the Institute.

(vii) One member appointed by the Director of the National
Science Foundation from officers or employees of the Foundation.

(viii) One member appointed by the Secretary of Commerce
from officere or employees of the Department of Commerce.

(B) (i) An appointed member may designate an individual to serve
on the committee on the member*s behalf. Such a designation may be
made only with the approval Of the applicable appointing authority
and only if the individual is from the entity from which the member
was appointed..

(ii) No individual may serve as a member of the committee for more
than four years in the aggregate. If any member of the committee
leaves the entity from which the member was appointed, such member
ma^ not continue as a member of the committee, and the member's
position shall be considered to be vacant. A vacancy in the committee
shall be filled in the same manner in which the original appointment
was made. \

(iii) Initial appointments to the committee shall be made not later
than the 60th day after the effective date of this Act. Not later than
the 90th day after such date the members of the committee shall hold a
meeting for the selection of a chairperson from among their number.

(C) (i) No member of the committee, or designee of such member,
shall accept employment or compensation from any person subject to
any requirement of this Act or of any rule promulgated or order issued
thereunder, for a period of at least 12 months after termination of
service on the committee.

89-139 (360) O - 76 — 2

90 STAT. 2012 PUBLIC LAW 94-469— OCT. 11, 1976

(ii) No person, while serving as a member of the committee, or des-
ignee of such member, may own any stocks or bonds, or have any
pecuniary interest, of substantial value in any person engaged in the
manufacture, processing, or distribution in commerce of any chemical
substance or mixture subject to any requirement of this Act or of any
rule promulgated or order issued thereunder.

(iii) The Administrator, acting through attorneys of the Environ-
mental Protection AgeQcy, or the Attorney General may bring an
action in the appropriate district court of the United States to restrain
any violation of this subparagraph.

(D) The Administrator shall provide the committee such admin-
istrative support services as may be necessary to enable the committee
to carry out its function under this subsection.

(f ) Required Actions. — Upon the receipt of —

(1) any test data required to be submitted under this Act, or

(2) any other information available to the Administrator,
which indicates- to the Administrator that there may be a reasonable
basis to conclude that a chemical substance or mixture presents or will
present a significant risk of serious or widespread harm to human
beings from cancer, gene mutations, or birth defects, the Administra-
tor shall, within the 180-day period beginning on the date of the receipt
of such data or information, initiate appropriate action under section
5, 6, or 7 to prevent or reduce to a sufficient extent such risk or publish
in the Federal Register a finding that such risk is not unreasonable. For
good cause shown the Administrator may extend such period for an

Publication in additional period of not more than 90 days. The Administrator shall
Federal Register, publish in the Federal Register notice of any such extension and the
reasons therefor. A finding by the Administrator that a risk is not
unreasonable shall be considered agency action for purposes of judicial
5 use 701. review under chapter 7 of title 5, United States Code. This subsection

shall not take effect until two years after the effective date of this Act.

(g) Petition for Standards for the Development of Test Data. —
A person intending to manufacture or process a chemical substance

In/ra. for which notice is required under section 5(a) and who is not required

under a rule under subsection (a) to conduct tests and submit data
on such substance may petition the Administrator to prescribe stand-
ards for the development of test data for sucli substance. The Admin-
istrator shall by order either grant or deny any such petition within
60 days of its receipt. If the petition is granted, the Administrator
shall prescribe such standards for sucli substance within 75 days of
Publication in the date the petition is granted. If the petition is denied, the Admin-
Federal Register, istrator shall publish, subjex't to section 14, in the Federal Register the
Post, p. 2034. reasons for such denial.

SEC. 5. MANUFACTURING AND PROCESSING NOTICES.
15 use 2604. (a) In General. — (1) Except as provided in subsection (h), no

person may —

(A) manufacture a new chemical substance on or after the 30th
day aft^r the date on which the Administrator first publishes the
list required by section 8 ( b ) , or

(B) manufacture or process any chemical substance for a use
which the Administrator has determined, in accordance with
paragraph (2) , is a significant new use,

unless such person submits to the Administrator, at least 90 days before
such manufacture or processing, a notice, in accordance with subsection
(d), of such person's intention to manufacture or process such sub-
stance and such person complies with any applicable requirement of
subsection (b).

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2013

(2) A determination by the Administrator that a use of a chemical
substance is a significant new use with respect to which notification
is required under paragraph (1) shall be made by a rule promulgated
after a consideration of all relevant factors, including —

(A) the projected volume of manufacturing and processing of
a chemical substance,

(B) the extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical
substance,

(C) the extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a
chemical substance, and

(D) the reasonably anticipated manner and methods of manu-
facturing, processing, distribution in commerce, and disposal of
a chemical substance.

(b) Submission of Test Data. — (1) (A) If (i) a person is required
by subsection (a) (1) to submit a notice to the Administrator before
beginning the manufacture or processing of a chemical substance,
and (ii) such person is required to submit test data for such sub-
stance pursuant to a rule promulgated under section 4 before the
submission of such notice, such person shall submit to the Adminis-
trator such data in accordance with such rule at the time notice is
submitted in accordance with subsection (a) (1).

<B) If- . .

(i) a person is required by subsection (a)(1) to submit a
notice to the Administrator, and

(ii) such person has been granted an exemption under section
4(c) from tne requirements of a rule promulgated under section
4 before the submission of such notice,

such person may not, before the expiration of the 90 day period which
begins on the date of the submission in accordance with such rule of
the test data the submission or development of which was the basis
for the exemption, manufacture such substance if such person is
subject to subsection (a)(1)(A) or manufacture or process such
substance for a significant new use if the person is subject to subsection
(a)(1)(B).
(2) (A) If a person —

(i) is required by subsection (a) (1) to submit a notice to the
Administrator before beginning the manufacture or processing
of a chemical substance listed under paragraph (4), and

(ii) is not required by a rule promulgated under section 4
before the submission of such notice to submit test data for such
substance,

such person shall submit to the Administrator data prescribed by
subparagraph (B) at the time notice is submitted in accordance with
subsection (a)(1).

(B) Data submitted pursuant to subparagraph (A) shall be data
which the person submitting the data believes show that —

(i) in the case of a substance with respect to which notice is
required under subsection (a) (1) (A), the manufacture, process-
ing, distribution in commerce, use, and disposal of the chemical
suDstance or any combination of such activities will not present
an unreasonable risk of injury to health or the environment, or

(ii) in the case of a chemical substance with respect to which
notice is required under subsection (a)(1)(B), the intended
significant new use of the chemical substance will not present an
unreasonable risk of injury to health or the environment.

90 STAT. 2014

PUBLIC LAW 94^9--OCT. 11, 1976

Post, p. 2034.

Oral

presentation.

Transcript.

Publication.

Publication in
Federal Register.

(3) Data submitted under paragraph (1) or (2) shall be made
available, subject to section 14, for examination by interested persons.

(4) (A) (i) The Administrator may, by rule, compile and keep
current a list of chemical substances with respect to which the
Administrator finds that the manufacture, processing, distribution in
commerce, use, or disposal, or any combination of such activities,
presents or may present an unreasonable risk of injury to health or
the environment.

(ii) In making a finding under clause (i) that the manufacture,
processing, distribution in commerce, use, or disposal of a chemical
substance or any combination of such activities presents or may present

Administrator shall consider all relevant factors, including —

(I) the effects of the chemical substance on health and the
magnitude of human exposure to such substance; and

(II) the effects of the chemical substance on the environment
and the magnitude of environmental exposure to such substance.

(B) The Administrator shall, in prescribing a rule under subpara-
graph (A) which lists any chemical substance, identify those uses,
if any, which the Administrator determines, by rule under subsection
(a) (2), would constitute a significant new use of such substance.

(C) Any rule imder subparagraph (A), and any substantive
amendment or repeal of such a rule, shall be promulgated pursuant
to the procedures specified in section 553 of title 5, L^nited States
Code, except that {i) the Administrator shall give interested persons
an opportunity for tne oral presentation of data, views, or arguments,
in addition to an opportunity to make written submissions, (ii) a
transcript shall be kept of any oral presentation, and (iii) the Admin-
istrator shall make and publish with the rule the finding described
in subparagraph (A).

(c) Extension of Xotice Period. — The Administrator may for
good cause extend for additional periods (not to exceed in the aggre-
gate 90 days) the period, prescribed by subsection (a) or (b) before
which the manufacturing or processing of a chemical substance sub-
ject to such subsection may begin. Subject to section 14, such an
extension and the reasons tnerefor shall be published in the Federal
Register and shall constitute a final agency action subject to judicial
review.

(d) Content of Notice ; Publications in the Federal Register. —
(1) The notice required by subsection (a) shall include —

(A) insofar as known to the person submitting the notice or
insofar as reasonably ascertainable, the information described in
subparagraphs (A), (B), (C), (D), (F), and (G) of section
8(a) (2), and

(IB) in such form and manner as the Administrator may pre-
scribe, any test data in the possession or control of the person
giving such notice which are related to the effect of any manu-
facture, processing, distribution in commerce, use, or disposal of
such substance or any article containing such substance, or of any
combination of such activities, on health or the environment, and
(C) a description of any other data concerning the environ-
mental and health effects of such substance, insofar as known to
the person making the notice or insofar as reasonably ascertain-

Such a notice shall be made available, subject to section 14. for exam-
ination by interested persons.

(2) Subject to section 14, not later than five days (excluding Satur-
days, Sundays and legal holidays) after the date of the receipt of a

able.

PUBUC LAW 94^9--OCT. 11, 1976 90 STAT. 2015

notice under subsection (a) or of data under subsection (b), the
Administrator shall publish in the Federal Register a notice which —

(A) identifies the chemical substance for which notice or data
has been received ;

(B) lists the uses or intended uses of such substance; and

(C) in the case of the receipt of data under subsection (b),
describes the nature of the tests performed on such substance and
any data which was developed pursuant to subsection (b) or a
rule under section 4.

A notice under this paragraph respecting a chemical substance shall
identify the chemical substance by generic class unless the Administra-
tor determines that more specific identification is required in the
public interest.

(3) At the beginning of each month the Administrator shall pub-
lish a list in the Federal Register of (A) each chemical substance for
which notice has been received under subsection (a) and for which
the notification period prescribed by subsection (a) , (b) , or (c) has not
expired, and (B) each chemical substance for which such notifica-
tion period has expired since the last publication in the Federal Regis-
ter of such list.

(e) Regulation Pending Development of Information. — (1) (A)
If the Administrator determines that —

(i) the information available to the Administrator is insuf-
ficient to permit a reasoned evaluation of the health and environ-
mental effects of a chemical substance with respect to which notice
is required by subsection (a) ; and

(ii) (I) in the absence of sufficient information to permit the
Administrator to make such an evaluation, the manufacture,
processing, distribution in commerce, use, or disposal of such
substance, or any combination of such activities, may present an
imreasonable risk of injury to health or the environment, or

(II) such substance is or will be produced in substantial quan-
tities, and such substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities or
there is or may be significant or substantial human exposure to the
substance,

the Administrator may issue a proposed order, to take effect on the Proposed order,
expiration of the notification period applicable to the manufactunng
or processing of such substance under subsection (a), (b), or (c), to
prohibit or limit the manufacture, processing, distribution in com-
merce, use, or disposal of such substance or to prohibit or limit any
combination of such activities.

(B) A proposed order may not be issued under subparagraph (A)
respecting a chemical substance (i) later than 45 days before the
expiration of the notification period applicable to the manufacture or
processing of such substance under subsection (a), (b), or (c), and
(ii) unless the Administrator has, on or before the issuance of the
proposed order, notified, in writing, each manufacturer or processor,
as the case may be, of such substance of the determination which
underlies such order.

(C) If a manufacturer or processor of a chemical substance to be
subject to a proposed order issued under subparagraph (A) files with
the Administrator (within the 30-day period beginning on the date
such manufacturer or processor received the notice required by subpar-
agraph (B) (ii)) objections specifying with particularity the provi-
sions of the order deemed objectionable and stating the grounds
therefor, the proposed order shall not take effect.

90 STAT. 2016 PUBLIC LAW 94-469— OCT. 11, 1976

Injunction, (2) (A) (i) Except as provided in clause (ii), if with respect to a

application. chemical substance with respect to which notice is required by subsec-

tion (a), the Administrator makes the determination described in
paragraph (1) (A) and if —

(I) the Administrator does not issue a proposed order under
paragraph (1) respecting such substance, or

(II) the Administrator issues such an order respecting such
substance but such order does not take effect because objections
were filed under paragraph (1) (C) with respect to it,

the Administrator, through attorneys of the Environmental Protection
Agency, shall apply to the United States District Court for the Dis-
trict of Columbia or the United States district court for the judicial
district in which the manufacturer or processor, as the case may be, of
such substance is found, resides, or transacts business for an injunction
to prohibit or limit the manufacture, processing, distribution in com-
merce, use, or disposal of such substance (or to prohibit or limit any
combination of such activities) .

(ii) If the Administrator issues a proposed order under paragraph
(1) (A) respecting a chemical substance but such order does not take
effect because objections have been filed under paragraph (1) (C) with
respect to it, the Administrator is not required to apply for an injunc-
tion under clause (i) respecting such substance if the Administrator
determines, on the basis of such objections, that the determinations
under paragraph ( 1 ) ( A) may not be made.

(B) A district court of the United States which receives an appli-
cation under subparagraph (A) (i) for an injunction respecting a
chemical substance shall issue such injunction if the court finds that —

(i) the information available to the Administrator is insufficient
to permit a reasoned evaluation of the health and environmental
effects of a chemical substance with respect to which notice is
required by subsection (a) ; and

(ii) (I) in the absence of sufficient information to permit the
Administrator to make such an evaluation, the manufacture, proc-
essing, distribution in commerce, use, or disposal of such
substance, or any combination of such activities, may present an
unreasonable risk of injury to health or the environment, or

(C) Pending the completion of a proceeding for the issuance of an
injunction under subparagraph (B) respecting a chemical substance,
the court may, upon application of the Administrator made through
attorneys of the Environmental Protection Agency, issue a temporary
restraining order or a preliminary injunction to prohibit the manu-
facture, processing, distribution in commerce, use, or disposal of such
a substance (or any combination of such activities) if the court finds
that the notification period applicable under subsection (a), (b), or
(c) to the manufacturing or processing of such substance may expire
before such proceeding can be completed.

(D) After the submission to the Administrator of test data sufficient
to evaluate the health and environmental effects of a chemical sub-
stance subject to an injunction issued under subparagraph (B) and
the evaluation of such data by the Administrator, the district court
of the United States which issued such injunction shall, upon petition,
dissolve the injunction unless the Administrator has initiated a pro-

PUBUC LAW 94-469— OCT. 11, 1976

90 STAT. 2017

ceeding for the issuance of a rule under section 6(a) respecting the
substance. If such a proceeding has been initiated, such court shall con-
tinue the injunction in effect until the effective date of the rule pro-
mulgated in such proceeding or, if such proceeding is terminated
without the promulgation of a rule, upon the termination of the pro-
ceeding, whichever occurs first.

(f ) Protection Against Unreasonable Risks. — (1) If the Admin-
istrator finds that there is a reasonable basis to conclude that the manu-
facture, processing, distribution in commerce, use, or disposal of a
chemical substance with respect to which notice is required by subsec-
tion (a), or that any combination of such activities, presents or wiU
present an unreasonable risk of injury to health or environment before
a rule promulgated under section 6 can protect against such risk, the
Administrator shall, before the expiration of the notification period
applicable under subsection (a), (b), or (c) to the manufacturing or
processing of such substance, take the action authorized by paragraph
(2) or (3) to the extent necessary to protect against such risk.

(2) The Administrator may issue a proposed rule under section Proposed rule
6(a) to apply to a chemical substance with respect to which a finding

was made under paragraph (1) —

(A) a i-equirement limiting the amount of such substance
which may be manufactured, processed, or distributed in
commerce,

(B) a requirement described in paragraph (2), (3), (4), (5),
(6), or (7) of section 6(a), or

Such a proposed rule shall be effective upon its publication in the Fed-
ei-al Register. Section 6(d)(2)(B) shall apply with respect to such
rule.

(3) (A) The Administrator may —

(i) issue a proposed order to prohibit the manufacture, process-
ing, or distrioution in commerce of a substance with respect to
which a finding was made under paragraph (1), or

(ii) apply, through attorneys of the Environmental Protection
Agency, to the United States District Court for the District of
Columbia or the United States district court for the judicial dis-
trict in which the manufacturer, or processor, as the case may be,
of such substance, is found, resides, or transacts business for an
injunction to prohibit the manufacture, processing, or distribu-
tion in commerce of such substance.

A proposed order issued under clause (i) respecting a chemical
substance shall take effect on the expiration of the notification period
applicable under subsection (a), (b), or (c) to the manufacture or
processing of such substance.

(B) If the district court of the United States to which an applica-
tion has been made under subparagraph (A) (ii) finds that there is a
reasonable basis to conclude that the manufacture, processing,
distribution in commerce, use, or disposal of the chemical substance
with respect to which such application was made, or that any combina-
tion of such activities, presents or will present an unreasonable risk
of injury to health or the environment before a rule promulgated
under section 6 can protect against such risk, the court shall issue
an injunction to prohibit the manufacture, processing, or distribution
in commerce of such substance or to prohibit any combination of such
activities.

Publication in
Federal Register.

Proposed order.

Injunction
application.

90 STAT. 2018 PUBLIC LAW 94^9— OCT. 11, 1976

(C) The provisions of subparagraphs (B) and (C) of subsection
(e) (1) shall apply with respect to an order issued under clause (i)
of subparagraph (A) ; and the provisions of subparagraph (C) of sub-
section (e) (2) shall apply with respect to an injunction issued under
subparagraph (B).

(D) If the Administrator issues an order pursuant to subparagraph
(A) (i) respecting a chemical substance and objections are filed in
accordance with subsection (e) (1) (C), the Administrator shall seek
an injunction under subparagraph (A) (ii) respecting such substance
unless the Administrator determines, on the basis of such objections,
that such substance does not or will not present an unreasonable risk
of injury to health or the environment.

(g) Statement of Reasons for Not Taking Action. — If the
Adininistrator has not initiated any action under this section or section
6 or 7 to prohibit or limit the manufacture, processing, distribution
in commeice, use, or disposal of a chemical substance, with respect to
which notification or data is required by subsection (a) (1) (B) or (b),
before the expiration of the notification period applicable to the manu-
facturing or processing of such substance, the Administrator shall
publish a statement of the Administrator's reasons for not initiating

Publication in such action. Such a statement shall be published in the Federal Reg-
Federal Register, ister before the expiration of such period. Publication of such state-
ment in accordance with the preceding sentence is not a prerequisite
to the manufacturing or processing of the substance with respect to
which the statement is to be published.

(h) Exemptions. — (1) The Administrator may, upon application,
exempt any person from any requirement of subsection (a) or (b) to
permit such person to manufacture or process a chemical^ substance
for test marketing purposes —

(A) upon a showing by such person satisfactory' to the Admin-
istrator that the manufacture, processing, distribution in
commerce, use, and disposal of such substance, and that any com-
bination of such activities, for such purposes will not present any
unreasonable risk of injury- to health or the environment, and

(B) under such restrictions as the Administrator considers
appropriate.

(2) (A) The Administrator may, upon application, exempt any per-
son from the requirement of subsection (b) (2) to submit data for a
chemical substance. If, upon receipt of an application under the pre-
ceding sentence, the Administrator determines that —

(i) the chemical substance with respect to which such applica-
tion was submitted is equivalent to a chemical substance for which
data has been submitted to the Administrator as required by sub-
section (b) (2), and

(ii) submission of data by the applicant on such substance
would be duplicative of data which has been submitted to the
Administrator in accordance with such subsection,

the Administrator shall exempt the applicant from tlie requirement
to submit such data on such substance. No exemption which is granted
under this subparagraph with respect to the submission of data for a
chemical substance may take effect before the beginning of the reim-
bursement period applicable to such data.
Fair and (B) If the Administrator exempts any person, under subpara<rraph

equitable (A), from Submitting data required under subsection fb) (2) for a

reimbursement. chemical substance because of the existence of previously submitted
data and if such exemption is granted during the reimbursement period
for such data, then (unless such person and the persons referred to in

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2019

clauses (i) and (ii) agree on the amount and method of reimbui-se-
ment) the Administrator shall order the person granted the exemption
to provide fair and equitable reimbursement (in an amount determined
under rules of the Administrator) —

(i) to the person who previously submitted the data on which
the exemption was based, for a portion of the costs incurred by
such person in complying with the requirement under subsection
(b) (2) to submit such data, and

(ii) to any other person who has been required under this sub-
paragraph to contribute with respect to such costs, for a portion
of the amount such person was required to contribute.

In promulgating rules for the determination of fair and equitable
reimbursement to the persons described in clauses (i) and (ii) for
costs incurred with respect to a chemical substance, the Administrator
shall, after consultation with the Attorney General and the Federal
Trade Commission, consider all relevant factors, including the effect
on the competitive position of the person required to provide reim-
bursement in relation to the persons to be reimbursed and the share of
the market for such substance of the person required to provide reim-
bursement in relation to the share of such market of the persons to be
reimbursed. For purposes of judicial review, an order under this
subparagraph shall be considered final agency action.

(C) For purposes of this paragraph, the reimbursement period for Reimbursement
any previously submitted data for a chemical substance is a period — period.

(i) beginning on the date of the termination of the prohibition,
imposed under this section, on the manufacture or processing of
such substance by the person who submitted such data to the
Administrator, and

(ii) ending —

(I) five years after the date referred to in clause (i), or

(II) at the expiration of a period which begins on the
date referred to in clause (i) and is equal to the period which
the Administrator determines was necessary to develop such
data,

whichever is later.

(3) The requirements of subsections (a) and (b) do not apply with
respect to the manufacturing or processing of any chemical sub-
stance which is manufactured or processed, or proposed to be manu-
factured or processed, only in small quantities (as defined by the
Administrator by rule) solely for purposes of —

(A) scientific experimentation or analysis, or

(B) chemical research on, or analysis of such substance or
another substance, including such research or analysis for the
development of a product,

if all persons engaged in such experimentation, research, or analysis
for a manufacturer or processor are notified (in such form and manner
as the Administrator may prescribe) of any risk to health which the
manufacturer, processor, or the Administrator has reason to believe
may be associated with such chemical substance.

(4) The Administrator may, upon application and by rule, exempt
the manufacturer of any new chemical substance from all or part of
the requirements of this section if the Administrator determines that
the manufacture, processing, distribution in commerce, use, or dis-
posal of such chemical substance, or that any combination of such
activities, will not present an unreasonable risk of injury to health or
the environment. A rule promulgated under this paragraph (and any
substantive amendment to, or repeal of, such a rule) shall be promul-
gated in accordance with paragraphs (2) and (3) of section 6(c).

89-139 (360) O - 76 - - 8

90 STAT. 2020

PUBLIC LAW 94-469— OCT. 11, 1976

Publication in
Federal Register.
Comments.

Publication in
Federal Register.

15 use 2605.

(5) The Administrator may, upon application, make the require-
ments of subsections (a) and (b) inapplicable with respect to the
manufacturing or processing of any chemical substance (A) which
exists temporarily as a result of a chemical reaction in the manufac-
turing or processing of a mixture or another chemical substance, and
(B) to which there is no, and will not be, human or environmental
exposure.

(6) Immediately upon receipt of an application under paragraph
(1) or (5) the Administrator shall publish in the Federal Register
notice of the receipt of such application. The Administrator shall give
interested persons an opportunity to comment upon any such applica-
tion and shall, within 45 days of its receipt, either approve or deny the
application. The Administrator shall publish in the Federal Register
notice of the approval or denial of such an application.

(i) Definition. — For purposes of this section, the terms "manufac-
ture" and "process" mean manufacturing or processing for commercial
purj)Oses.

SEC. 6. REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND
MIXTURES.

(a) Scope of Regulation. — If the Administrator finds that there is
a reasonable basis to conclude that the manufacture, processing, dis-
tribution in connnerce, use, or disposal of a chemical substance or
mixture, or that any combination of such activities, presents or will
present an unreasonable risk of injury to health or the environment,
the Administrator shall by rule apply one or more of the following
requirements to such substance or mixture to the extent necessary to
protect adequately against such risk using the least burdensome
requirements :

(1) A rc(<[uirement (A) prohibiting the manufacturing, process-
ing, or distribution in connnerce of such substance or mixture, or
(B) limiting the amount of such substance or mixture which may
be manufactured, processed, or distributed in commerce.

(2) A requirement —

(A) prohibiting the manufacture, processing, or distribu-
tion in commerce of such substance or mixture for (i) a
particular use or (ii) a particular use in a concentration in
excess of a level specified by the Administrator in the rule
imposing the requirement, or

(B) limiting the amount of such substance or mixture
which may be manufactured, processed, or distributed in
commerce for (i) a particular use or (ii) a particular use
in a concentration in excess of a level specified by the
Administrator in the rule imposing the requirement.

(3) A requirement that such substance or mixture or any
article containing such substance or mixture be marked with or
accompanied by clear and adequate warnings and instructions
with respect to its use, distribution in commerce, or disposal or
with i-espect to any combination of such activities. The form and
content of such warnings and instructions shall be prescribed by
the Administrator.

(4) A requirement that manufacturers and processors of such
substance or mixture make and retain records of the processes
used to manufacture or process such substance or mixture and
monitor or conduct tests which are reasonable and necessary to
assure compliance with the requirements of any rule applicable
under this subsection.

PUBLIC LAW 94^9— OCT. 11, 1976 90 STAT. 2021

(5) A requirement prohibiting or otherwise regulating any
manner or method of commercial use of such substance or
mixture.

(6) (A) A requirement prohibiting or otherwise regulating any
manner or method of disposal of such substance or mixture, or
of any article containing such substance or mixture, by its manu-
facturer or processor or by any other person who uses, or disposes
of, it for commercial purposes.

(B) A requirement under subparagraph (A) may not require
any person to take any action which would be in violation of
any law or requirement of, or in effect for, a State or political
subdivision, and shall require each person subject to it to notify
each State and political subdivision in which a required disposal
may occur of such disposal.

(7) A requirement directing manufacturers or processors of
such substance or mixture (A) to give notice of such unreasonable
risk of injury to distributors in commerce of such substance or
mixture and, to the extent reasonably ascertainable, to other per-
sons in possession of such substance or mixture or exposed to such
substance or mixture, (B) to give public notice of such risk of
injury, and (C) to replace or repurchase such substance or
mixture as elected by the person to which the requirement is
directed.

Any requirement (or combination of requirements) imposed under
this subsection may be limited in application to specified geographic
areas.

(b) Quality Control. — If the Administrator has a reasonable
basis to conclude that a particular manufacturer or processor is manu-
facturing or processing a chemical substance or mixture in a manner
which unintentionally causes the chemical substance or mixture to
present or which will cause it to present an unreasonable risk of
injury to health or the environment —

(1) the Administrator may by order require such manufac-
turer or processor to submit a description of the relevant quality
control procedures followed in the manufacturing or processing
of such chemical substance or mixture ; and

(2) if the Administrator determines —

(A) that such quality control procedures are inadequate
to prevent the chemical substance or mixture from presenting
such risk of injury, the Administrator may order the manu-
facturer or processor to revise such quality control procedures
to the extent necessary to remedy such inadequacy ; or

(B) that the use of such quality control procedures has
resulted in the distribution in commerce of chemical substances
or mixtures which present an unreasonable risk of injury to
health or the environment, the Administrator may order the
manufacturer or processor to (i) give notice of such risk to
processors or distributors in commerce of any such sub-
stance or mixture, or to both, and, to the extent reasonably
ascertainable, to any other person in possession of or exposed
to any such substance, (ii) to give public notice of such risk,
and (iii) to provide such replacement or repurchase of any
such substance or mixture as is necessary to adequately pro-
tect health or the environment.

A detennination under subparagraph (A) or (B) of paragraph (2) Hearing,
shall be made on the record after opportunity for hearing in accord-
ance with section 654 of title 5, United States Code. Any manufacturer

90 STAT. 2022

PUBLIC LAW 94-469— OCT. 11, 1976

Statement,
publication.

5 use 556, 557.
Notice,
publication.
Written data,
views, arguments,
submittal.
Hearing.
Final rule.

Informal
heariogs.

or processor subject to a requirement to replace or repurchase a chem-
ical substance or mixture may elect either to replace or repurchase
the substance or mixture and shall take either such action in the man-
ner prescribed by the Administrator.

(c) Promulgation of Subsection (a) Rules. — (1) In promulgat-
ing any rule under subsection (a) with respect to a chemical substance
or mixture, the Administrator shall consider and publish a statement
with respect to —

(A) the effects of such substance or mixture on health and the
magnitude of the exposure of human beings to such substance or
mixture.

( B ) the etfects of such substance or mixture on the environment
and the magnitude of the exposure of the environment to such
substance or mixture,

(D) the reasonably ascertainable economic consequences of the
rule, after consideration of the effect on the national economy,
small business, technological iimovation, the enviromnent, and
public health.

If the Administrator determines that a risk of injury to health or the
environment could be eliminated or reduced to a sufficient extent by
actions taken under another Federal law (or laws) administered in
whole or in part by the Administrator, the Administrator may not
promulgate a rule under subsection (a) to protect against such risk
of injury unless the Administrator finds, in the Administrators dis-
cretion, that it is in the public interest to protect against such risk
under this Act. In making such a finding the Administrator.shall con-
sider (i) all relevant aspects of the risk, as determined by the Adminis-
trator in the Administrators discretion, (ii) a comparison of the
estimated costs of complying with actions taken under this Act and
under such law (or laws), and (iii) the relative efficiency of actions
under this Act and under such law (or laws) to protect against such
risk of injury.

(2) When prescribing a rule under subsection (a) the Adminis-
trator shall proceed in accordance with section 553 of title 5, United
States Code (without regard to any reference in such section to sec-
tions 556 and 557 of such title), and shall also (A) publish a notice of
proposed rulemaking stating with particularity the reason for the
proposed rule: (B) allow interested persons to submit written data,
views, and arguments, and make all such submissions publicly avail-
able; (C) provide an oppoitunity for an informal hearing in accord-
ance with paragraph (H) ; (D) promulgate, if appropriate, a final
rule based on the matter in the rulemaking record (as defined in section
19(a) ), and (E) make and publish with the rule the finding described
in subsection (a).

(3) Informal hearings required by paragraph (2) (C) shall be con-
ducted by the Administrator in acx:ordance with the following
requirements :

(A) Subject to subparagraph (B), an interested [)erson is
entitled —

(i) to present such person's position orally or by docu-
mentary submissions (or both), and

(ii) if the Administrator determines that there are dis-
puted issues of material fact it is nex'CvSsary to resolve, to
present such rebuttal submissions and to conduct (or have
conducted under subparagraph (B) (ii) ) such cross-examina-

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2023

tion of persons as the Administrator determines (I) to be
appropriate, and (II) to be required for a full and true dis-
closure with respect to such issues.

(B) The Administrator may prescribe such rules and make such Rules,
rulings concerning procedures m such hearings to avoid unneces-
sary costs or delay. Such rules or rulings may include (i) the
imposition of reasonable time limits on each interested person's

oral presentations, and (ii) requirements that any cross-examina-
tion to which a person may be entitled under subparagraph (A)
be conducted by the Administrator on behalf of that person in such
manner as the Administrator determines (I) to be appropriate,
and (II) to be required for a full and true disclosure with respect
to disputed issues of material fact.

(C) (i) Except as provided in clause (ii), if a group of persons
each of whom under subparagraphs (A) and (B) would be
entitled to conduct (or have conducted) cross-examination and
who are determined by the Administrator to have the same or
similar interests in the proceeding cannot agree upon a single
representative of such interests for purposes of cross-examination,
the Administrator may make rules and rulings (I) limiting the
representation of such interest for such purposes, and (II) gov-
erning the manner in which such cross-examination shall be
limited.

(ii) "V^Hicn any person who is a member of a group with respect
to which the Administrator has made a determination under
clause (i) is unable to agree upon group representation with the
other membei-s of the group, then such pei-son shall not be denied
under the authority of clause (i) the opportunity to conduct (or
have conducted) cross-examination as to issues affecting the per-
son's particular interests if (I) the person satisfies the Admin-
istrator that the person has made a reasonable and good faith
effort to reach agi-eement upon group representation with tlie
other members of the group and (II) the Administrator deter-
mines that there are substantial and relevant issues which are not
adequately presented by the gioup representative.

(D) A verbatim transcript shall be taken of any oral presen- Verbatim
tation made, and cross-examination conducted in any informal transcript,
hearing under this subsection. Such transcript shall be available

to the public.

(4) (A) The Administrator may, pursuant to rules prescribed by the Compensation.
Administrator, provide compensation for reasonable attorneys' fees,
expert witness fees, and other costs of participating in a rulemaking
proceeding for the promulgation of a rule under subsection (a) to
any person —

(i) who represents an interest which would substantially con-
tribute to a fair determination of the issues to be resolved in the
proceeding, and

(ii) if-

(I) the economic interest of such pei-son is small in com-
parison to the costs of effective participation in the proceed-
ing by such person, or

(II) such person demonstrates to the satisfaction of the
Administrator that such person does not have sufficient
resources adequately to participate in the proceeding without
compensation under this subparagraph.

In determining for purposes of clause (i) if an interest will substan-
tially contribute to a fair determination of the issues to be resolved in

90 STAT. 2024 PUBLIC LAW 94-469— OCT. 11, 1976

a proceeding, the Administrator shall take into account the number
and complexity of such issues and the extent to which representation
of such interest will contribute to widespread public participation in
the proceeding and representation of a fair balance of interests for
the resolution of such issues.

(B) In determining whether compensation should be provided to
a person under subparagraph (A) and the amount of such compensa-
tion, the Administrator shall take into account the financial burden
which will be incurred by such person in participating in the rule-
making proceeding. The Administrator shall take such action as
may be necessary to ensure that the aggregate amount of compensa-
tion paid under this paragraph in any fiscal year to all persons who,
in rulemaking proceedings in which they receive compensation, ai"e
persons who either —

(i) would be regulated by the proposed rule, or

(ii) represent persons who would be so regulated,

may not exceed 25 per centum of the aggregate amount paid as com-
pensation under this paragraph to all persons in such fiscal year.

(5) Paragraph (1), (2), (3), and (4) of this subsection apply
to the pronmlgation of a rule repealing, or making a substantive
amendment to, a rule promulgated under subsection (a).

(d) Effective Date. — (1) The Administrator shall specify in any
rule under subsection (a) the date on which it shall take effect, which
date shall be as soon as feasible.
Publication in (2) (A) The Administrator may declare a proposed rule under sub-

Federal Register, section (a) to be effective upon its publication in the Federal Register
and until the effective date of final action taken, in accordance with
subparagraph (B), respecting such rule if —

(i) the Administrator determines that —

(I) the manufacture, processing, distribution in com-
merce, use, or disposal of the chemical substance or mixture
subject to such proposed rule or any combination of such
activities is likely to result in an unreasonable risk of serious
or widespread injury to health or the environment before
such effective date; and

(II) making such proposed rule so effective is necessary to
protect the public interest ; and

(ii) in the case of a proposed rule to prohibit the manufacture,
processing, or distribution of a chemical substance or mixture
because of the risk determined under clause (i) (I), a court has
in an action under section 7 granted relief with respect to such
risk associated with such substance or mixture.

Such a proposed rule which is made so effective shall not, for pur-
poses of judicial review, be considered final agency action.
Notice. (B) If the Administrator makes a proposed rule effective upon its

publication in the Federal Register, the Administrator shall, as expe-
ditiously as possible, give interested persons prompt notice of such
action, j)rovide reasonable opportunity, in accordance with paragraphs
(2) and (3) of subsection (c), for a hearing on such rule, and either
promulgate such rule (as proposed or with modifications) or revoke
it; and if such a hearing is requested, the Administrator shall com-
mence the hearing within five days from the date such request is made
unless the Administrator and the person making the request agree
upon a later date for the hearing to begin, and after the hearing is
concluded the Administrator shall, within ten days of the conclusion
of the hearing, either promulgate such rule (as proposed or with
modifications) or revoke it.

PUBLIC LAW 94-469— OCT. 11, 1976

90 STAT. 2025

(e) PoLYCHLORiNATED BiPiLENYLS. — (1) Within six months after
the effective date of this Act the Administrator shall promulgate
rules to —

(A) prescribe methods for the disposal of poly chlorinated
biphenyls, and

(B) require polychlorinated biphenyls to be marked with clear
and adequate warnings, and instructions with respect to their
processing, distribution in commerce, use, or disposal or with
respect to any combination of such activities.

Requirements prescribed by rules under this paragraph shall be con-
sistent with the requirements of paragraphs (2) and (3).

(2) (A) Except as provided under subparagraph (B), effective one
year after the effective date of this Act no person may manufacture,
l)rocess, or distribute in commerce or use any polychlorinated biphenyl
in any manner other than in a totally enclosed manner.

(B) The Administrator may by rule authorize the manufacture,
processing, distribution in commerce or use (or any combination of
such activities) of any polychlorinated biphenyl in a maimer other than
in a totally enclosed manner if the Administrator finds that such manu-
facture, processing, distribution in commerce, or use (or combination
of such activities) will not present an unreasonable risk of injury to
health or the environment.

(C) For the purposes of this paragraph, the term "totally enclosed
manner" means any manner which will ensure that any exposure of
human beings or the environment to a polychlorinated biphenyl will
be insignificant as determined by the Administrator by rule.

(3) (A) P^xcept as provided in subparagraphs (B) and (C) —

(i) no person may manufacture any polychlorinated biphenyl
after two years after the effective date of this Act, and

(ii) no person may process or distribute in commerce any poly-
chlorinated biphenyl after two and one-half years after such date.

(B) Any pei-son may petition the Administrator for an exemption
from the requirements of subparagraph (A), and the Administrator
may grant by rule such an exemption if the Administrator finds
that—

(i) an unreasonable risk of injury to health or environment
would not result, and

(ii) good faith efforts have been made to develop a chemical
substance which does not present an unreasonable risk of injury
to health or the environment and which may be substituted for
such polychlorinated biphenyl.

An exemption granted under this subparagraph shall be subject to
such terms and conditions as the Administrator may prescribe and
shall be in effect for such period (but not more than one year from
the date it is granted) as the Administrator may prescribe.

(C) Subparagraph (A) shall not apply to the distribution in com-
merce of any polychlorinated biphenyl if such polychlorinated
biphenyl was sold for purposes other than resale before two and one
half years after the date of enactment of this Act.

(4) Any rule under paragraph (1), (2)(B), or (3) (B) shall be
promulgated in accordance with paragraphs (2), (3), and (4) of sub-
section (c).

(5) This subsection does not limit the authority of the Adminis-
trator, under any other provision of this Act or any other Federal law,
to take action respecting any polychlorinated biphenyl.

Rules.

"Totally enclosed
manner."

Petition for
exemption.

Terms and
conditions.

79-313 0 - 77 -3

90 STAT. 2026 PUBLIC LAW 94-469— OCT. 11, 1976

SEC. 7. IMMINENT HAZARDS.

Civil action. (a) AcTioxs AUTHORIZED AND REQUIRED. — (1) The Administrator

15 use 2606. may commence a civil action in an appropriate district court of the
L^nited States —

(A) for seizure of an imminently hazardous chemical sub-
stance or mixture or any article containing such a substance or
mixture,

(B) for relief (as authorized by subsection (b)) against any
person who manufactuies, processes, distributes in commerce, or
uses, or disposes of, an imminently hazardous chemical substance
or mixture or any article containing such a substance or mix-
ture, or

( C ) for both such seizure and relief.

A civil action may be commenced under this paragraph notwith-
standing the existence of a rule under section 4, 5, or 6 or an order
under section 5, and notwithstanding the pendency of any adminis-
trative or judicial proceeding under any provision of this Act.

(2) If the Administrator has not made a rule under section 6(a)
immediately effective (as authorized by subsection 6(d) (2) (A) (i) )
with respect to an imminently hazardous chemical substance or mix-
ture, the Administrator shall commence in a district court of the United
States with respect to such substance or mixture or article containing
such substance or mixture a civil action described in subparagraph
( A ) , ( B ) , or ( C ) of paragraph ( 1 ) .
Jurisdiction. (b) Relief Authorized. — (1) The district court of the United

States in which an action under subsection (a) is brought shall have
jurisdiction to grant such temporary or permanent relief as^may be
necessary to protect health or the environment from the unreasonable
risk associated with the chemical substance, mixture, or article involved
in such action.

(2) In the case of an action under subsection (a) brought against
a pei-son who manufactures, processes, or distributes in commerce a
chemical substance or mixture or an article containing a chemical sub-
stance or mixture, the relief authorized by paragraph (1) may include
the issuance of a mandatory order requiring (A) in the case of pur-
chasers of such substance, mixture, or article known to the defendant,
notification to such purchasers of the risk associated with it; (B) pub-
lic notice of such risk; (C) recall; (D) the replacement or repurchase
of such substance, mixture, or .article; or (E) any combination of the
actions described in the preceding clauses.

(3) In the case of an action under subsection (a) against a chemi-
cal substance, mixture, or article, such substance, mixture, or article
may be proceeded against by process of libel for its seizure and con-
demnation. Proceedings in such an action shall conform as nearly as
possible to proceedings in rem in admiralty.

(c) Venue and Consolidation. — (1) (A) An action under subsec-
tion (a) against a person who manufactures, processes, or distributes a
chemical substance or mixture or an article containing a chemical sub-
stance or mixture may be brought in the United States District Court
for the District of Columbia or for any judicial district in which any
of the defendants is found, resides, or transacts business ; and process
in such an action may be served on a defendant in any other district
in which such defendant resides or may be found. An action under sub-
section (a) against a chemical substance, mixture, or article muy be
brought in any United States district court within the jurisdiction of
which the substance, mixture, or article is found.

(B) In determining the judicial district in which an action may be
brought under subsection (a) in instances in which such action may

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2027

be brought in more than one judicial district, the Administrator shall
take into account the convenience of the parties.

(C) Subpeonas requiring attendance of witnesses in an action
brought under subsection (a) may be served in any judicial district.

(2) Whenever proceedings under subsection (a) involving identi-
cal chemical substances, mixtures, or articles are pending in courts in
two or more judicial districts, they shall be consolidated for trial by
order of any such court upon application reasonably made by any
party in interest, upon notice to all parties in interest,

(d) Action LTnder Section 6. — Where appropriate, concurrently
with the filing of an action under subsection (a) or as soon thereafter
as may be practicable, the Administrator shall initiate a proceeding
for the ])romulgation of a rule under section 6(a).

(e) Representation. — Notwithstanding any other provision of law,
in any action under subsection (a), the Administrator may direct
attorneys of the Environmental Protection Agency to appear and
represent the Administrator in such an action.

(f) Definition. — For the purposes of subsection (a), the term
"imminently hazardous chemical substance or mixture" means a chemi-
cal substance or mixture which presents an imminent and unreason-
able risk of serious or widespread injury to health or the environment.
Such a risk to health or the environment shall be considered imminent
if it is shown that the manufacture, processing, distribution in com-
merce, use, or disposal of the chemical substance or mixture, or that any
combination of such activities, is likely to result in such injury to
health or the environment before a final rule under section 6 can
protect against such risk.

SEC. 8. REPORTING AND RETENTION OF INFORMATION.

(a) Reports. — (1) The Administrator shall promulgate rules Rules,
under which— 15 USC 2607.

(A) each person (other than a small manufacturer or proc-
essor) who manufactures or processes or proposes to manufacture
or process a chemical substance (other than a chemical substance
described in subparagraph (B)(ii)) shall maintain such rec-
ords, and shall submit to the Administrator such reports, as the
Administrator may reasonably require, and

(B) each person (other than a small manufacturer or proc-
essor) who manufactures or processes or proposes to manufacture
or process —

(i) a mixture, or

(ii) a chemical substance in small quantities (as defined
by the Administrator by rule) solely for purposes of scientific
experimentation or analysis or chemical research on, or
analysis of, such substance or another substance, including
any such research or analysis for the development of a
product,

shall maintain records and submit to the Administrator reports
but only to the extent the Administrator determines the main-
tenance of records or submission of reports, or both, is necessary
for the effective enforcement of this Act.
The Administrator may not require in a rule promulgated under this
paragraph the maintenance of records or the submission of reports
with respect to changes in the proportions of the components of a
mixture unless the Administrator finds that the maintenance of such
records or the submission of such reports, or both, is necessary for
the effective enforcement of this Act. For purposes of the compilation

90 STAT. 2028 PUBLIC LAW 94-469— OCT. 11, 1976

of the list of chemical substances required under subsection (b), the
Administrator shall promulgate rules pursuant to this subsection not
later than 180 days after the effective date of this Act.

(2) The Administrator may require under paragraph (1) mainte-
nance of records and reporting with respect to the following insofar
as known to the person making the report or insofar as reasonably
ascertainable:

(A) The common or trade name, the chemical identity, and the
molecular structure of each chemical substance or mixture for
which such a report is required.

(B) The categories or proposed categories of use of each such
substance or mixture.

(C) The total amount of each such substance and mixture
manufactured or processed, reasonable estimates of the total
amount to be manufactured or processed, the amount manufac-
tured or processed for each of its categories of use, and reasonable
estimates of the amount to be manufactured or processed for each
of its categories of use or proposed categories of use.

(D) A description of the byproducts resulting from the manu-
facture, processing, use, or disposal of each such substance or
mixture.

(E) All existing data concerning the environmental and health
effects of such substance or mixture.

(F) The number of individuals exposed, and reasonable esti-
mates of the number who will be exposed, to such substance or
mixture in their places of employment and the duration of such
exposure.

(G) In the initial report under paragraph (1) on such Substance
or mixture, the manner or method of its disposal, and in any
subsequent report on such substance or mixture, any change in
such manner or method.

To the extent feasible, the Administrator shall not require under
paragraph (1), any reporting which is unnecessary or duplicative.

(3) (A) (i) The Administrator may by rule require a small manu-
facturer or processor of a chemical substance to submit to the Admin-
istrator such information respectin/^ the chemical substance as the
Administrator may require for publication of the first list of chemi-
cal substances required by subsection (b).

(ii) The Administrator may by rule require a small manufacturer
or processor of a chemical substance or mixture —

(I) subject to a rule proposed or promulgated under section 4,
5(b) (4) , or 6, or an order in effect under section 5(e), or

(II) with respect to which relief has been granted pursuant to
a civil action brought under section 5 or 7,

to maintain such records on such substance or mixture, and to submit
to the Administrator such reports on such substance or mixture, as
the Administrator may reasonably require. A rule under this clause
requiring reporting may require reporting with respect to the matters
referred to in paragraph (2) .
Standards. (B) The Administrator, after consultation with the Administrator

of the Small Business Administration, shall by rule prescribe stand-
ards for determining the manufacturers and processors which qualify
as small manufacturers and processors for purposes of this paragraph
and paragraph ( 1 ) .

(b) Inventory. — (1) The Administrator shall compile, keep cur-
rent, and publish a list of each chemical substance which is manufac-
tured or processed in the United States. Such list shall at least include
each chemical substance which any person reports, imder section 5 or

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2029

subsection (a) of this section, is manufactured or processed in the
United States. Such list may not include any chemical substance
which was not manufactured or processed in the United States within
three years before the effective date of the rules promulgated pur-
suant to the last sentence of subsection (a) (1). In the case of a chemi-
cal substance for which a notice is submitted in accordance with
section 5, such chemical substance shall be included in such list as of
the earliest date (as determined by the Administrator) on which such
substance was manufactured or processed in the United States. The
Administrator shall first publish such a list not later than 315 days
after the effective date of this Act. The Administrator shall not include
in such list any chemical substance which is manufactured or processed
only in small quantities (as defined by the Administrator by rule)
solely for purposes of scientific experimentation or analysis or chemi-
cal research on, or analysis of, such substance or another substance,
including such research or analysis for the development of a product.

(2) To the extent consistent with the purposes of this Act, the
Administrator may, in lieu of listing, pursuant to paragraph (1), a
chemical substance individually, list a category of chemical substances
in which such substance is included.

(c) Records. — Any person who manufactures, processes, or distrib-
utes in commerce any chemical substance or mixture shall maintain
records of significant adverse reactions to health or the environment,
as determined by the Administrator by rule, alleged to have been
caused by the substance or mixture. Records of such adverse reactions
to the health of employees shall be retained for a period of 30 years
from the date such reactions were first reported to or known by the
person maintaining such records. Any other record of such adverse
reactions shall be retained for a period of five years frojii the date
the information contained in the record was first reported to or known
by the person maintaining the record. Records required to be main-
tained under this subsection shall include records of consumer allega-
tions of personal injury or harm to health, reports of occupational
disease or injury, and reports or complaints of injury to the environ-
ment submitted to the manufacturer, processor, or distributor in com-
merce from any source. Upon request of any duly designated
representative of the Administrator, each person who is required to
maintain records under this subsection shall permit the inspection of
such records and shall submit copies of such records.

(d) Health and Safety Studies. — The Administrator shall pro- Rules,
mulgate rules under which the Administrator shall require any person

who manufactures, processes, or distributes in commerce or who pro-
poses to manufacture, process, or distribute in commerce any chemical
substance or mixture (or with respect to paragraph (2), any person
who has possession of a study) to submit to the Administrator —

(1) lists of health and safety studies (A) conducted or initiated
by or for such person with respect to such substance or mixture
at any time, (B) known to such person, or (C) reasonably ascer-
tainable by such person, except that the Administrator may exclude
certain types or categories of studies from the requirements of this
subsection if the Administrator finds that submission of lists of
such studies are unnecessary to carry out the purposes of this Act;
and

(2) copies of any study contained on a list submitted pursuant
to paragraph (1) or otherwise known by such person.

(e) Notice to Administrator of Substantial Risks. — ^Any person
who manufactures, processes, or distributes in commerce a chemical
substance or mixture and who obtains information which reasonably

90 STAT. 2030 PUBLIC LAW 94^9— OCT. 11, 1976

supports the conclusion that such substance or mixture presents a
substantial risk of injury to health or the environment shall imme-
diately inform the Administrator of such information unless such
person has actual knowledge that the Administrator has been ade-
quately informed of such mformation.

(f ) Definitions.— For purposes of this section, the terms "manufac-
ture" and '"process'- mean manufacture or process for commercial
purposes.

SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS.

15 use 2608. (a) Laws Xot Administered by the Administrator. — (1) If

the Administrator has reasonable basis to conclude that the manufac-
ture, processing, distribution in commerce, use, or disposal of a chemical
substance or mixture, or that any combination of such activities, pre-
sents or will present an unreasonable risk of injury to health or the
environment and determines, in the Administrator's discretion, that
such risk may be prevented or reduced to a sufficient extent by action
taken under a Federal law not administered by the Administrator,

^^eport- the Administrator shall submit to the agency which administers such

law a report which describes such risk and includes in such description
a specification of the activity or combination of activities which the
Administrator has reason to believe so presents such risk. Such report
shall also request such agency —

(A) (i) to determine if the risk described in such report may
be prevented or reduced to a sufficient extent by action taken under
such law, and

(ii) if the agency determines that such risk may be so prevented
or reduced, to issue an order declaring whether or not the activity
or combination of activities specified in the description of such
risk presents such risk ; and

(B) to respond to the Administrator with respect to the matters
described in subparagraph ( A ) .

Publication in Any report of the Administrator shall include a detailed statement of
Federal Register, the information on which it is based and shall be published in the
Federal Register. The agency receiving a request under such a report
shall make the requested determination, issue the requested order,
and make the requested response within such time as the Administrator
specifies in the request, but such time specified may not be less than
90 days from the date the request was made. The response of an agency
shall be accompanied by a detailed statement of the findings and
conclusions of the agency and shall be published in the Federal Regis-
ter.

(2) If tlie Administrator makes a report under paragraph (1) with
respect to a chemical substance or mixture and the agency to which
such report was made either —

(A) issues an order declaring that the activity or combination
of activities specified in the description of the risk described in
the report does not present the risk described in the report, or

(B) initiates, within 90 days of the publication in the Federal
Register of the response of the agency under paragraph (1 ) , action
under the law (or laws) administered by such agency to protect
against such risk associated with such activity or combination of
activities,

the .Administrator may not take any action imder section 6 or 7 with
respect to such risk.

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2031

administered by it to protect against such risk consult with the Admin-
istrator for the purpose of avoiding duplication of Federal action
against such risk.

(b) Laws Administered by the Administrator. — The Administra-
tor shall coordinate actions taken under this Act with actions taken
under other Federal laws administered in whole or in part by the
Administrator. If the Administrator determines that a risk to health or
the environment associated with a chemical substance or mixture could
be eliminated or reduced to a sufficient extent by actions taken under
tlie authorities contained in such other Federal laws, the Administrator
shall use such authorities to protect against sucli risk unless the Admin-
istrator determines, in the Administrator's discretion, that it is in the
public interest to protect against such risk by actions taken under
this Act. This subsection sluill not be construed to relieve the Admin-
istrator of any requirement imposed on the Administrator by such
other Federal laws.

(c) Oc^cuPATTONAL Satoty AND Health. — lu exercising any author-
ity under this Act, the Administrator shall not, for purposes of section

4(b)(1) of the Occupational Safety and Health Act of 1970, be 29 USC 651 note,
deemed to be exercising statutory authority to prescribe or enforce
standards or regulations affecting occupational safety and health.

(d) Coordination. — In administering this Act, the Administrator
shall consult and coordinate with tlie Secretary of Health, Education,
and Welfare and the heads of any other appropriate Federal execu-
tive department or agency, any relevant independent regulatory
agency, and any other appropriate instrumentality of the Federal Gov-
ernment for the purpose of achieving the maximum enforcement of this
Act while imposing the least burdens of duplicative requirements on
those subject to the Act and for other purposes. The Administrator
shall, in the report required by section 30, report, annually to the
Congress on actions taken to coordinate with such other Federal
departments, agencies, or instrumentalities, and on actions taken to
coordinate the authority imder this Act with the authority granted
under other Acts leferred to in subsection (b).

SEC. 10. RESEARCH. DEVELOPMENT, COLLECTION, DISSEMINATION,
AND UTILIZATION OF DATA.

(a) Authority.— The Administratoi- shall, in consultation and 15 USC 2609.
cooperation with the Secretary of Health, Education, and Welfare

and with other heads of appropriate departments and agencies, con-
duct such research, development, and monitoring as is necessary to
carry out the purposes of tliis Act. The Administrator may enter into
contracts and may make grants for resesirch, development, and moni-
toring under this subsection. Contracts may be entered into under this
subsection without regard to sections 3648 and 3709 of the Revised
Statutes (31 U.S.C. 529, 14 U.S.C. 5).

(b) Data Systems. — (1) The Administrator shall establish, admin-
ister, and be responsible for the continuing activities of an interagency
committee which shall design, establish, and coordinate an efficient and
effective system, within the Environmental Protection Agency, for
the collection, dissemination to other Federal departments and agen-
cies, and use of data submitted to the Administrator under this Act.

(2) (A) The Administrator shall, in consultation and cooperation
with the Secretary of Health, Education, and Welfare and other heads
of appropriate departments and agencies design, establish, and coordi-
nate an efficient and effective system for the retrieval of toxicological
and other scientific data which could be useful to the Administrator in
carrying out the purposes of this Act. Systematized retrieval shall be
developed for use by all Federal and other departments and agencies

90 STAT. 2032 PUBLIC LAW 94-469— OCT. 11, 1976

with responsibilities in the area of regulation or study of chemical
substances and mixtures and their effect on health or the environment.

(B) The Administrator, in consultation and cooperation with the
Secretary of Health, Education, and Welfare, may make grants and
enter into contracts for the development of a data retrieval system
described in subparagraph (A). Contracts may be entered into under
this subparagraph without regard to sections 3648 and 3709 of the
Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5) .

(c) Screening Techniques. — The Administrator shall coordinate,
with the Assistant Secretary for Health of the Department of Health,
Education, and Welfare, research imdertaken by the Administrator
and directed toward the development of rapid, reliable, and economical
screening techniques for carcinogenic, mutagenic, teratogenic, and
ecological effects of chemical substances and mixtures.

(d) Monitoring. — The Administrator shall, in consultation and
cooperation with the Secretary of Health, Education, and Welfare,
establish and be responsible for research aimed at the development, in
cooperation with local, State, and Federal agencies, of monitoring
techniques and instruments which may be used in the detection of toxic
chemical substances and mixtures and which are reliable, economical,
and capable of being implemented under a wide variety of conditions.

(e) Basic Research. — The Administrator shall, in consultation and
cooperation with the Secretary of Health, Education, and Welfare,
establish research programs to develop the fundamental scientific basis
of the screening and monitoring techniques described in subsections
(c) and (d), the bounds of the reliability of such techniques, and the
opportunities for their improvement.

(f) Training. — The Administrator shall establish and promote
programs and workshops to train or facilitate the training of Federal
laboratory and technical personnel in existing or newly developed
screening and monitoring techniques.

(g) Exchange of Research and Development Results. — The
Administrator shall, in consultation with the Secretary of Health,
Education, and Welfare and otlier heads of appropriate departments
and agencies, establish and coordinate a system for exchange ainong
Federal, State, and local authorities of research and development
results respecting toxic chemical substances and mixtures, including
a system to facilitate and promote the development of standard data
format and analysis and consistent testing procedures.

SEC. 11. INSPECTIONS AND SUBPOENAS.
15 use 2610. (a) In General. — For purposes of administering this Act, the

Administrator, and any duly designated representative of the Admin-
istrator, may inspect any establishment, facility, or other premises in
which chemical substances or mixtures are manufactured, processed,
stored, or held before or after their distribution in commerce and any
conveyance being used to transport chemical substances, mixtures, or
such articles in connection with distribution in commerce. Such an
inspection may only be made upon the presentation of appropriate
credentials and of a written notice to the owner, operator, or agent in
charge of the premises or conveyance to be inspected. A separate notice
shall be given for each such inspection, but a notice shall not be
resquired for each entry made during the period covered by the inspec-
tion. Each such inspection shall be commenced and completed with
reasonable promptness and shall be conducted at reasonable times,
within reasonable limits, and in a reasonable manner.

(b) Scope. — (1) Except as provided in paragraph (2), an inspec-
tion conducted under subsection (a) shall extend to all things within

PUBLIC L.\W 94-469— OCT. 11, 1976 90 STAT. 2033

the premises or conveyance inspected (including records, files, papers,
processes, controls, and facilities) bearing on whether the requirements
of this Act applicable to the chemical substances or mixtures within
such premises or conveyance have been complied with.
(2) No inspection under subsection (a) shall extend to —
(A) financial data,

B ) sales data ( other than shipment data ) ,

C) pricing data,

(D) personnel data, or

(E) research data (other than data required by this Act or
under a rule promulgated thereunder) ,

unless the nature and extent of such data are described with reasonable
specificity in the written notice required by subsection (a) for such
inspection.

(c) Subpoenas. — In carrying out this Act, the Administrator may
by subpoena require the attendance and testimony of witnesses and
the production of reports, papers, documents, answei"s to questions,
and otlier information that the Administrator de-ems necessary. Wit-
nesses shall be paid the same fees and mileage that are paid witnesses
in the courts of the United States. In the event of contumacy, failure,
or refusal of any person to obey any such subpoena, any district court
of the United States in which venue is proper shall have jurisdiction
to order any such jxM-son to comply with such subpoena. Any failure
to obey such an order of the court is punishable by the court as a con-
tempt thereof.

SEC. 12. EXPORTS.

(a) In Gener.\l. — (1) Except as provided in paragraph (2) and 15USC2611.
subsection (b), this Act (other than se<!tion 8) shall not apply to any

chemical substance, mixture, or to an article containing a chemical
substance or mixture, if —

(A) it can be shown that such substance, mixture, or article is
being manufactured, processed, or distributed in commerce for
export from the United States, unless such substance, mixture, or
article was, in fact, manufactured, processed, or distributed in
commerce, for use in the United States, and

(B) such substance, mixture, or article (when distributed in
commerce), or any container in which it is enclosed (when so dis-
tributed), bears a stamp or label stating that such substance, mix-
ture, or article is intended for export.

(2) Paragraph (1) shall not apply to any chemical substance, mix-
ture, or article if the Administrator finds that the substance, mixture,
or article will present an unreasonable risk of injury to health within
the United States or to the environment of the United States. The
Administrator may require, under section 4, testing of any cliemical
substance or mixture exempted from this Act by paragraph (1) for
the purpose of determining whether or not such substance or mixture
presents an unreasonable risk of injury to health within the United
States or to the environment of the United States.

(b) Notice. — (1) If any person exports or intends to export to a
foreign country a chemical substance or mixture for which the submis-
sion of data is required under section 4 or 5(b), such person shall
notify the Administrator of such exportation or intent to export and
the Administrator shall furnish to the government of such country
notice of the availability of the data submitted to the Administrator
under such section for such substance or mixture.

(2) If any person exports or intends to export to a foreign country
a chemical substance or mixture for which an order has been issued

90 STAT. 2034 PUBLIC LAW 94-469— OCT. 11, 1976

under section 5 or a rule has been proposed or promulgated under sec-
tion 5 or 6, or with respect to which an action is pending, or relief has
been granted under section 5 or 7, such person shall notify the Admin-
istrator of such exportation or intent to export and the Administrator
shall furnish to the government of such country notice of such rule,
order, action, or relief.

SEC. 13. ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES.

15 use 2612. (a) Ix General. — (1) The Secretary of the Treasury shall refuse

entry into the customs territory of the United States (as defined in

19 use 1202. genei al headnote 2 to the Tariff Schedules of the United States) of
any chemical substance, mixture, or article containing a chemical sub-
stance or mixture offered foi- such entry if —

(A) it fails to comply with any rule in effect under this Act, or

(B) it is offered for entry in violation of section 5 or 6, a rule or
order under section 5 or 6, or an order issued in a civil action
brought under section 5 or 7.

Notification. (2) If a chemical substance, mixture, or article is refused entry

under paragraph (1), the Secretary of the Treasury shall notify the
consignee of such entry refusal, shall not release it to the consignee,
and shall cause its disposal or storage (under such rules as the Secre-
tary of the Treasury may prescribe) if it has not been exported by the
consignee within 90 days from the date of receipt of notice of such
refusal, except that the Secretary of the Treasury may, pending a
review by the Administrator of the entry refusal, release to the con-
signee such substance, mixture, or article on execution of bond for the
amount of the full invoice of such substance, mixture, or article (as
such value is set forth in the customs entry), together with the duty
thereon. On failure to return such substance, mixture, or article for
any cause to the custody of the Secretary of the Treasury when
demanded, such consignee shall be liable to the L'nited States for liqui-
dated damages equal to the full amount of such bond. All charges for
storage, cartage, and labor on and for disposal of substances, mixtures,
or articles which are refused entry or release under this section shall
be paid by the owner or consignee, and in default of such payment
shall constitute a lien against any future entry made by such owner or
consignee.

(b) Rules. — The Secretary of the Treasury, after consultation with
the Administrator, shall issue rules for the administration of subsec-
tion (a) of this section.
SEC. 14. DISCLOSURE OF DATA.
15 use 2613. (a) In General. — Except as provided by subsection (b), any

information reported to, or otherwise obtained by, the Administrator
(or any representative of the Administrator) under this Act, which is
exempt from disclosure pursuant to subsection (a) of section 552 of
title 5, United States Code, by reason of subsection (b) (4) of such
section, shall, notwithstanding the provisions of an}' other section of
this Act, not be disclosed by the Administrator or by any officer or
employee of the United States, except that such information —

(1) shall be disclosed to any officer or employee of the United
States—

(A) in connection with the official duties of such officer
or employee under any law for the protection of health or
the environment, or

(B) for specific law enforcement purposes ;

(2) shall be disclosed to contractors with the United States and
employees of such contractors if in the opinion of the Administra-

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2035

tor such disclosure is necessary for the satisfactory performance
by the contractor of a contract with the United States entered into
on or after the date of enactment of this Act for the performance
of work in connection with this Act and under such conditions
as the Administrator may specify ;

(3) shall be disclosed if the Administrator determines it neces-
sary to protect health or tlie environment against an unreasonable
risk of injury to health or the environment ; or

(4) may Ibe disclosed when relevant in any proceeding under
this Act, except that disclosure in such a proceeding shall be
made in such manner as to preserve confidentiality to the extent
practicable without impairing tlie proceeding.

In any proceeding under section 552(a) of title 5, United States Code,
to obtain information the disclosure of which lias been denied because
of the provisions of this subsection, the Administrator may not rely on
section 55*2(1)} (3) of such title to sustain the Administrator's action.

(b) Data From Health and Safety Studies. — (1) Subsection (a)
does not prohibit the disclosure of —

(A) any health and safety study which is submitted under this
Act with respect to —

(i) any chemioal substance or mixture which, on the date
on which such study is to be disclosed has been offered for
commercial distribution, or

(ii) any chemical substance or mixture for which testing is
required under section 4 or for which notification is required
under section 5, and

(B) any data reported to. or otherwise obtained by, the Admin-
istrator from a health and safety study which relates to a chemical
substance or mixture described in clause (i) or (ii) of subpara-
graph (A).

This paragraph does not authorize the release of any data which dis-
closes processes used in the manufacturing or processing of a chemical
substance or mixture or, in the case of a mixture, the release of data
disclosing the portion of the mixture comprised by any of the chemical
substances in the mixture.

(2) If a request is made to the Administrator under subsection (a)
of section 552 of title 5, United States Code, for information which is
described in the first sentence of paragraph (1) and which is not
information described in the second sentence of such paragraph, the
Administrator may not deny such request on the basis of subsection
(b) (4) of such section.

(c) I)est(;nati()x and Release of Confidential Data. — (1) In sub-
mitting data under this Act, a manufacturer, processor, or distributor
in commerce may (A) designate the data which such person believes
is entitled to confidential treatment under subsection (a), and (B)
submit such designated data separately from other data submitted
under this Act. A designation under this paragraph shall be made in
writing and in such manner as the Administrator may prescribe.

(2) (A) Except as provided by subparagraph (B), if the Adminis-
trator proposes to release for inspection data which has been desig-
nated under paragraph (1)(A). the Administrator shall notify, in
writing and by certified mail, the manufacturer, processor, or distrib-
utor in commerce who submitted such data of the intent to release such
data. If the release of siich data is to be made pursuant to a request
made under section 552(a) of title 5, United States Code, such notice
shall be given immediateh' upon approval of such request by the
Administrator. The Administrator may not release such data until

90 STAT. 2036 PUBLIC LAW 94-469— OCT. 11, 1976

the expiration of 30 days after the manufacturer, processor, or distrib-
utor in commerce submitting such data has received the notice required
by this subparagraph.
Notification. (B) (i) Subparagraph (A) shall not apply to the release of infor-

mation under paragraph (1), (2), (3), or (4) of subsection (a), except
that the Administrator may not release data under paragraph (3) of
subsection (a) unless the Administrator has notified each manufac-
turer, processor, and distributor in commerce who submitted such data
of such release. Such notice shall be made in writing by certified mail
at least 15 days before the release of such data, except that if the
Administrator determines that the release of such data is necessary
to protect against an imminent, unreasonable risk of injury to health
or the environment, such notice may be made by such means as the
Administrator determines will provide notice at least 24 hours before
such release is made.

(ii) Subparagraph (A) shall not apply to the release of information
described in subsection (b)(1) other than information described in
the second sentence of such subsection.

(d) Criminal Penalty for Wrongfut^ Disclosure. — (1) Any
officer or employee of the United States or former officer or employee
of the United States, who by virtue of such employment or official
position has obtained possession of, or has access to, material the dis-
closure of which is prohibited by subsection (a), and who knowing
that disclosure of such material is prohibited by such subsection, will-
fully discloses the material in any manner to any person not entitled to
receive it, shall be guilty of a misdemeanor and fined not more than
$5,000 or imprisoned for not more than one year, or both. Section
1905 of title 18, United States Code, does not apply with respect to
the publishing, divulging, disclosure, or making known of, or making
available, information reported or otherwise obtained under this Act.

(2) For the purposes of paragraph (1), any contractor with the
United States who is furnished information as authorized by subsec-
tion (a) (2), and any employee of any such contractor, shall be con-
sidered to be an employee of the United States.

(e) Access by Congress. — Notwithstanding any limitation con-
tained in this section or any other provision of law, all information
reported to or otherwise obtained by the Administrator (or any repre-
sentative of the Administrator) under this Act shall be made available,
upon written request of any duly authorized committee of the Con-
gress, to such committee.

SEC. 15. PROHIBITED ACTS.
15 use 2614. It shall be unlawful for any person to —

(1) fail or refuse to comply with (A) any rule promulgated or
order issued under section 4, (B) any requirement prescribed by
section 5 or 6, or (C) any rule promulgated or order issued under
section 5 or 6 ;

(2) use for commercial purposes a chemical substance or mix-
ture which such person knew or had reason to know was manufac-
tured, processed, or distributed in commerce in violation of section
5 or 6, a rule or order under section 5 or 6, or an order issued in
action brought under section 5 or 7 ;

(3) fail or refuse to (A) establish or maintain records, (B)
submit reports, notices, or other information, or (C) permit access
to or copying of records, as required by this Act or a rule there-
under; or

(4) fail or refuse to permit entry or inspection as required by
section 11.

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2037

SEC. 16. PENALTIES.

(a) Civil. — (1) Any person who violates a provision of section 15 15 USC 2615.
shall be liable to the United States for a civil penalty in an amount

not to exceed $25,000 for each such violation. Each day such a viola-
tion continues shall, for purposes of this subsection, constitute a sepa-
rate violation of section 15.

(2) (A) A civil penalty for a violation of section 15 shall be assessed Hearing,
by the Administrator by an order made on the record after oppor-
tunity (provided in accordance with this subparagraph) for a hearing

in accordance with section 554 of title 5, United States Code. Before
issuing such an order, the Administrator shall give written notice to
the person to be assessed a civil penalty under such order of the Admin-
istrator's proposal to issue such order and provide such person an
opportunity to request, within 15 days of the date the notice is received
by such person, such a hearing on the order.

(B) In determining the amount of a civil penalty, the Administra-
tor shall take into account the nature, circumstances, extent, and
gravity of the violation or violations and, with respect to the violator,
ability to pay, effect on ability to continue to do business, any history
of prior such violations, the degree of culpability, and such other
matters as justice may require.

(C) The Administrator may compromise, modify, or remit, with
or without conditions, any civil penalty which may be imposed under
this subsection. The amount of such penalty, when finally determined,
or the amount agreed upon in compromise, may be deducted from
any sums owing by the United States to the person charged.

(3) Any person who requested in accordance with paragraph (2) Petition for
(A) a hearing respecting the assessment of a civil penalty and who is judicial review,
aggrieved by an prder asse^sin^ a civil penalty may file a petition for

judicial review of such order with the United States Court of Appeals
for the District of Columbia Circuit or for any other circuit in which
such person resides or transacts business. Such a petition may only be
filed within the 30-day period beginning on the date the order making
such assessment was issued.

(4) If any person fails to pay an assessment of a civil penalty —

(A) after the order making the assessment has become a final
order and if such person does not file a petition for judicial review
of the order in accordance with paragraph (3), or

(B) after a court in an action brought under paragraph (3)
has entered a final judgment in favor of the Administrator,

the Attorney General shall recover the amount assessed (plus interest
at currently prevailing rates from the date of the expiration of the 30-
day period referred to in paragraph (3) or the date of such final
judgment, as the case may be) in an action brought in any appropriate
district court of the United States. In such an action, the validity,
amount, and appropriateness of such penalty shall not be subject to
review.

(b) Criminal. — Any person who knowingly or willfully violates
any provision of section 15 shall, in addition to or in lieu of any civil
penalty which may be imposed under subsection (a) of this section for
such violation, be subject, upon conviction, to a fine of not more than
$25,000 for each day of violation, or to imprisonment for not more
than one year, or both.

SEC. 17. SPECIFIC ENFORCEMENT AND SEIZURE.

(a) Specific Enforcement. — (1) The district courts of the United 15 USC 2616.
States shall have jurisdiction over civil actions to —
(A) restrain any violation of section 15,

90 STAT. 2038 PUBLIC LAW 94-469— OCT. 11, 1976

(B) restrain any person from taking any action prohibited by
section 5 or 6 or by a rule or order under section 5 or 6,

(D) direct any manufacturer or processor of a chemical sub-
stance or mixture manufactured or processed in violation of sec-
tion 5 or 6 or a rule or order under section 5 or 6 and distributed
in commerce, (i) to give notice of such fact to distributors in
commerce of such substance or mixture and, to the extent reason-
ably ascertainable, to other persons in possession of such sub-
stance or mixture or exposed to such substance or mixture, (ii) to
give public notice of such risk of injury, und (iii) to either replace
or repurchase such substance or mixture, whichever the person to
which the requirement is directed elects.

(2) A civil action described in paragraph ( 1 ) may be brought —

(A) in the case of a civil action described in subparagraph (A)
of such paragraph, in the United States district court for the judi-
cial district wherein any act, omission, or transaction constituting
a violation of section 15 occurred or wherein the defendant is found
or transacts business, or

(B) in the case of any other civil action described in such para-
graph, in the United States district court for the judicial district
wherein the defendant is found or transacts business.

In any such civil action process may be served on a defendant in any
judicial district in which a defendant resides or may be found. Sub-
poenas requiring attendance of witnesses in any such action may be
served in any judicial district.

(b) Seizure. — Any chemical substance or mixture which was manu-
factured, processed, or distributed in commerce in violation of this Act
or any rule promulgated or order issued under this Act or any article
containing such a substance or mixture shall be liable to be proceeded
against, by process of libel for the seizure and condemnation of such
substance, mixture, or article, in any district court of the United States
within the jurisdiction of which such substance, mixture, or article is
found. Such proceedings shall conform as nearly as possible to proceed-
ings in rem in admiralty.
SEC. 18. PREEMPTION.
15 use 2617. (a) Effect on State Law. — (1) Except as provided in paragraph

(2) , nothing in this Act shall affect the authority of any State or politi-
cal subdivision of a State to establish or continue in effect regulation
of any chemical substance, mixture, or article containing a chemical
substance or mixture.

(2) Except as provided in subsection (b) —

(A) if the Administrator requires by a rule promulgated under
section 4 the testing of a chemical substance or mixture, no State or
political subdivision may, after the effective date of such rule,
establish or continue in effect a requirement for the testing of such
substance or mixture for purposes similar to those for which test-
ing is required under such rule ; and

(B) if the Administrator prescribes a rule or order under sec-
tion 5 or 6 (other than a rule imposing a requirement deecrilDed
in subsection (a) (6) of section 6) which is applicable to a chemical
substance or mixture, and which is designed to protect against a
risk of injury to health or the environment associated with such
substance or mixture, no State or political subdivision of a State
may, after the effective date of such requirement, establish or
continue in effect, any requirement which is applicable to such sub-
stance or mixture, or an article containing such substance or mix-

PUBLIC LAW 94-469~0CT. 11, 1976

90 STAT. 2039

Petition.
15 use 2618.

ture, and which is designed to protect against such risk unless such
requirement (i) is identical to the requirement prescribed by the
Administrator, (ii) is adopted under the authority of the Clean
Air Act or any other Federal law, or (iii) prohibits the use of such
substance or mixture in such State or political subdivision (other
than its use in the manufacture or processing of other substances
or mixtures).

(b) Exemption. — Upon application of a State or political subdivi- Application,
sion of a State the Administrator may by rule exempt from subsection
(a)(2), under such conditions as may be prescribed in such rule, a
requirement of such State or political subdivision designed to protect
against a risk of injury to health or the environment associated with
a chemical substance, mixture, or article containing a chemical sub-
stance or mixture if —

(1) compliance with the requirement would not cause the
manufacturing, processing, distribution in commerce, or use of the
substance, mixture, or article to be in violation of the applicable
requirement under this Act described in subsection (a)(2), and
^2) the State or political subdivision requirement (A) provides
a significantly higher degree of protection from such risk than the
requirement under this Act described in subsection (a)(2) and
(B) does not, through difficulties in marketing, distribution, or
other factors, unduly burden interstate commerce.
SEC. 19. JUDICUL REVIEW.

(a) In Gener.\l. — (1)(A) Not later than 60 days after the date
of the promulgation of a rule under section 4(a), 5(a) (2), 5(b) (4),
6(a), 6(e), or 8, any person may file a petition for judicial review of
such rule with the United States Court of Appeals for the District of
Columbia Circuit or for the circuit in which such person resides or in
wliich such person's principal place of business is located. Courts
of appeals of the Ignited States shall have exclusive jurisdiction of
any action to obtain judicial review (other tlian in an enforcement
proceeding) of such a rule if any district court of the United States
would liave had jurisdiction of such action but for this subparagraph.

(R) Courts of appeals of the United States shall have exclusive
jurisdiction of any action to obtain judicial review (other than in an
enforcement proceeding) of an order issued under subparagraph (A)
or (B) of sectioft 6(b)(1) if any district court of the United States
would have had jurisdiction of such action but for this subparagraph.

(2) Copies of any petition filed under paragraph (1)(A) sliall he
transmitted forthwith to the Administrator and to the Attorney Gen-
eral by the clerk of the court with which such petition was filed. The
provisions of section 2112 of title 28, United States Code, shall apply
to the filing of the rulemaking record of proceedings on which the
Administrator based the rule being reviewed under this section and to
the transfer of proceedings between United States courts of appeals.

(3) For purposes of this section, the term "rulemaking record"
means —

(A) the rule being reviewed under this section ;

(B) in the case of a rule under section 4(a) , the finding required
by such section, in the case of a rule under section 5(b) (4), the
finding required by such section, in the case of a rule under section
6(a) the finding required by section 5(f) or 6(a), as the case may
be, in the case of a rule under section 6(a) , the statement required
by section 6(c) (1), and in the case of a rule under section 6(e),
the findings required by paragraph (2)(B) or (3)(B) of such
section, as the case may be ;

Jurisdiction.

Petition copies,
transmittal to
Administrator
and Attorney
General.

"Rulemaking
record."

90 STAT. 2040

PUBLIC LAW 94-469— OCT. 11, 1976

Notice,

publication in
Federal Register.

Review.

(D) any written submission of interested parties respecting the
promulgation of such rule ; and

(E) any other information which the Administrator considers
to be relevant to such rule and which the Administrator identified,
on or before the date of the promulgation of such rule, in a notice
published in the Federal Register.

(b) Additional Submissions and Presentations ; Modifications. —
If in an action under this section to review a rule the petitioner or the
Administrator applies to the court for leave to make additional oral
submissions or written presentations respecting such rule and shows
to the satisfaction of the court that such submissions and presentations
would be material and that there were reasonable grounds for the sub-
missions and failure to make such submissions and presentations in
the proceeding before the Administrator, the court may order the
Administrator to provide additional opportunity to make such sub-
missions and presentations. The Administrator may modify or set
aside the rule being reviewed or make a new rule by reason of the
additional submissions and presentations and shall file such modified
or new rule with the return of such submissions and presentations.
The court shall thereafter review such new or modified rule.

(c) Standard of Review. — (1) (A) Upon the filing of a petition
under subsection (a) (1) for judicial review (,f a rule, the court shall
have jurisdiction (i) to grant appropriate relief, includiBg interim
relief, as provided in chapter 7 of title 5, United States Code, and
(ii) except as otherwise provided in subparagraph (B), to review
such rule in accordance with chapter 7 of title 5, United States Code.

(B) Section 706 of title 5, United States Code, shall apply to review
of a rule under this section, except that —

(i) in the case of review of a rule under section 4(a), 5(b) (4),
6(a), or 6(e), the standard for review prescribed by paragraph
(2) (E) of such section 706 shall not apply and the court shall
hold unlawful and set aside such rule if the court finds that the
rule is not supported by substantial evidence in the rulemaking
record (as defined in subsection (a)(3)) taken as a whole;

(ii) in the case of review of a rule under section 6(a), the court
shall hold unlawful and set aside such rule if it finds that—

(I) a determination by the Administrator under section
6(c) (3) that the petitioner seeking review of such rule is not
entitled to conduct (or have conducted) cross-examination or
to present rebuttal submissions, or

(II) a rule of, or ruling by, the Administrator under sec-
tion 6(c) (3) limiting such petitioner's cross-examination or
oral presentations,

has precluded disclosure of disputed material facts which was
necessary to a fair determination by the Administrator of the
rulemaking proceeding taken as a whole; and section 706(2) (D)
shall not apply with respect to a determination, rule, or ruling
referred to in subclause (I) or (II) ; and

(iii) the court may not review the contents and adequacy of—

(I) any statement required to be made pursuant to section
6(c)(1), or

(II) any statement of basis and purpose required by sec-
tion 553(c) of title 5, United States Code, to be incorporated
in the rule

except as part of a review of the rulemaking record taken as a
whole.

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2041

The term "evidence" as used in clause (i) means any matter in the "Evidence."
rulemaking record.

(C) A determination, rule, or ruling of the Administrator described
in suDparagraph (B)(ii) may be reviewed only in an action under
this section and only in accordance with such subparagraph.

(2) The judgment of the court affirming or setting aside, in whole
or in part, any rule reviewed in accordance with this section sliall be
final, subject to review by the Supreme Court of the United States
upon certiorari or certification, as provided in section 1254 of title 28,
United States Code.

(d) Fees and costs. — The decision of the court in an action com-
menced under subsection (a), or of the Supreme Court of the United
States on review of such a decision, may include an award of costs of
suit and reasonable fees for attorneys and expert witnesses if the court
determines that such an award is appropriate.

(e) Other remedies. — The remedies as provided in this section shall
be in addition to and not in lieu of any other remedies provided by law.
SEC. 20. CITIZENS' CIVIL ACTIONS.

(a) In General. — Except as provided in subsection (b) , any person 15 USC 2619.
may commence a civil action —

(1) against any person (including (A) the United States, and
(B) any other governmental instrumentality or agency to the
extent permitted by the eleventh amendment to the Constitution)
who is alleged to be in violation of this Act or any. rule promul-
gated imder section 4, 5, or 6 or order issued under section 5
to restrain such violation, or

(2) against the Administrator to compel the Administrator
to perform any act or duty under this Act which is not discre-
tionary.

Any civil action under paragraph (1) shall be brought in the United
States district court for the district in which the alleged violation
occurred or in which the defendant resides or in which the defendant's
principal place of business is located. Any action brought under para-
graph (2) shall be brought in the United States District Court for
the District of Columbia, or the United States district court for the
judicial district in which the plaintiff is domiciled. The district courts Jurisdiction,
of the United States shall have jurisdiction over suits brought under
this section, without regard to the amount in controversy or the citizen-
ship of the parties. In any civil action under this subsection process
may be served on a defendant in any judicial district in which the
defendant resides or may be found and subpoenas for witnesses may
be served in any judicial district.

(b) LiMrrATioN. — No civil action may be commenced —

(1) under subsection (a) (1) to restrain a violation of this Act
or rule or order under this Act —

(A) before the expiration of 60 days after the plaintiff Notice,
has given notice of such violation (i) to the Administrator,

and (ii) to the person who is alleged to have committed such
violation, or

(B) if the Administrator has commenced and is diligently
prosecuting a proceeding for the issuance of an order under
section 16(a) (2) to require compliance with this Act or with
such rule or order or if the Attorney General has commenced
and is diligently prosecuting a civil action in a court of the
United States to require compliance with this Act or with
such rule or order, but if such proceeding or civil action is
commenced after the giving of notice, any person giving such
notice may intervene as a matter of right in such proceeding
or action ; or

79-313 O - 77 - 4

90 STAT. 2042 PUBLIC LAW 94-469--0CT. 11, 1976

Notice. (2) under subsection (a) (2) before the expiration of 60 days

after the plaintiff has given notice to the Administrator of the
alleged failure of the Administrator to perform an act or duty
which is the basis for such action or, in the case of an action under
such subsection for the failure of the Administrator to file an
action under section 7, before the expiration of ten days after
such notification.

Rule. Notice under this subsection shall be given in such manner as the

Administrator shall prescribe by rule.

(c) General. — (1) In any action under this section, the Adminis-
trator, if not a party, may intervene as a matter of right.

(2) The court, in issuing any final order in any action brought pur-
suant to subsection (a), may award costs of suit and reasonable fees
for attoineys and expert witnesses if the court determines that such
an award is appropriate. Any court, in issuing its decision in an action
brought to review such an order, may award costs of suit and reason-
able fees for attorneys if the court determines that such an award
is appropriate.

(3) Xothing in this section shall restrict any right which any person
(or class of persons) may have under any statute or common law to
seek enforcement of this Act or any rule or order under this Act
or to seek any other relief.

(d) Consolidation. — When two or more civil actions brought under
subsection (a) involving the same defendant and the Si{m^ issues or
violations are pending in two or more judicial districts, «uch pending
actions, upon application of such defendants to such actions which is
made to a court in which any such action is brought, may, if such court
in its discretion so decides, be consolidated for trial by order (issued
after giving all parties reasonable notice and opportunity to be heard)
of such court and tried in —

(1) any district which is selected by such defendant and in
which one of such actions is pending,

(2) a district which is agreed upon by stipulation between all
the parties to such actions and in which one of such actions is
pending, or

(3) a district which is selected by the court and in which one
of such actions is pending.

The court issuing such an order shall give prompt notification of the
order to the other courts in which the civil actions consolidated under
the order are pending.
SEC. 21. CITIZENS' PETITIONS.
15 use 2620. (a) In General. — Any person may petition the Administrator to

initiate a proceeding for the issuance, amendment, or repeal of a rule
under section 4, 6, or 8 or an order under section 5(e) or (6) (b) (2).

(b) Procedures. — (1) Such petition shall be filed in the principal
office of the Administrator and shall set forth the facts which it is
claimed establish that it is necessary to issue, amend, or repeal a rule
under section 4, 6, or 8 or an order under section 5(6), 6(b) (1) (A),
or 6(b)(1)(B).

Public hearing. (2) The Administrator may hold a public hearing or may conduct

such investigation or proceeding as the Administrator deems appro-
priate in order to determine whether or not such petition should be
granted.

(3) "Within 90 days after filing of a petition described in paragraph
(1), the Administrator shall either grant or deny the petition. If the
Administrator grants such petition, the Administrator shall promptly

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2043

commence an appropriate proceeding in accordance with section 4,
5, 6, or 8. If the Administrator denies such petition, the Administrator Publication in
shall publish in the Federal Register the Administrator's reasons Fe<leral Register,
for such denial.

(4) (A) If the Administrator denies a petition filed under this CivU action,
section (or if the Administrator fails to grant or deny such petition

within the 90-day period) the petitioner may commence a civil action
in a district court of the United States to compel the Administrator
to initiate a rulemaking proceeding as requested in the petition. Any
such action shall be filed within 60 days after the Administrator's
denial of the petition or, if the Administrator fails to grant or deny
the petition within 90 days after filing the petition, within 60 days
after the expiration of the 90-day period.

(B) In an action under subparagraph (A) respecting a petition
to initiate a proceeding to issue a rule under section 4, 6, or 8 or an
order under section 5(e) or 6(b) (2), the petitioner shall be provided
an opportunity to have such petition considered by the court in a
de novo proceeding. If the petitioner demonstrates to the satisfaction
of the court by a preponderance of the evidence that —

(i) in the case of a petition to initiate a proceeding for the
issuance of a rule under section 4 or an order under section 5(e) —

(I) information available to the Administrator is insuffi-
cient to permit a reasoned evaluation of the health and
environmental effects of the chemical substance to be subject
to such rule or order; and

(II) in the absence of such information, the substance may
present an unreasonable risk to health or the environment,
or the substance is or will be produced in substantial quan-
tities and it enters or may reasonably be anticipated to enter
the environment in substantial quantities or there is or may
be significant or substantial human exposure to it; or

(ii) in the case of a petition to initiate a proceeding for the
issuance of a rule under section 6 or 8 or an order under section
6(b) (2), there is a reasonable basis to conclude that the issuance
of such a rule or order is necessary to protect health or the
environment against an unreasonable risk of injury to health or
the environment.

the court shall order the Administrator to initiate the action requested
by the petitioner. If the court finds that the extent of the risk to
health or the environment alleged by the petitioner is less than the
extent of risks to health or the environment with respect to which
the Administrator is taking action under this Act and there are
insufficient resources available to the Administrator to take the action
requested by the petitioner, the court may permit the Administrator
to defer initiating the action requested by the petitioner until such time
as the court prescribes.

(C) The court in issuing any final order in any action brought pur-
suant to subparagraph (A) may award costs of suit and reasonable
fees for attorneys and expert witnesses if the court determines that
such an award is appropriate. Any court, in issuing its decision in an
action brought to review such an order, may award costs of suit and
reasonable fees for attorneys if the court determines that such an
award is appropriate.

(5) The remedies under this section shall be in addition to, and not
in lieu of, other remedies provided by law.

90 STAT. 2044

PUBLIC LAW 94-469— OCT. 11, 1976

15 use 2621.

Publication in
Federal Register.
Notice to
congressional
committee.

15 use 2622.

Notification.

Investigation.
Notification.

Notice, hearing.

SEC. 22. NATIONAL DEFENSE WAIVER.

The Administrator shall waive compliance with any provision of
this Act upon a request and determination by the President that the
requested waiver is necessarjr in the interest of national defense. The
Administrator shall maintain a written record of the basis upon
which such waiver was granted and make such record available for in
camera examination when relevant in a judicial proceeding under
this Act. Upon the issuance of such a waiver, the Administrator shall
publish in the Federal Register a notice that the waiver was granted
for national defense purposes, unless, upon the request of the Presi-
dent, the Administrator determines to omit such publication because
the publication itself would be contrary to the interests of national
defense, in which event the Administrator shall submit notice thereof
to the Armed Services Committees of the Senate and the House of
Representatives.

SEC. 23. EMPLOYEE PROTECTION.

(a) In General. — No employer may discharge any employee or
otherwise discriminate against any employee with respect to the
employee's compensation, terms, conditions, or privileges of employ-
ment because the employee (or any person acting pursuant to a request
of the employee) has —

(1) commenced, caused to be commenced, or is about to com-
mence or cause to be commenced a proceeding under this Act ;

(2) testified or is about to testify in any such proo«eding; or

(3) assisted or participated or is about to assist or participate
in any manner in such a proceeding or in any other action to
carry out the purposes of this Act.

(b) Remedy. — (1) Any employee who believes that the employee
has been discharged or otherwise discriminated against by any person
in violation of subsection (a) of this section may, within 30 days after
such alleged violation occurs, file (or have any person file on the
employee's behalf) a complaint with the Secretary of Labor (here-
inafter in this section referred to as the "Secretary") alleging such
discharge or discrimination. Upon receipt of such a complaint, the
Secretary shall notify the person named in the complaint of the filing
of the complaint.

(2) (A) Upon receipt of a complaint filed under paragraph (1), the
Secretary shall conduct an investigation of the violation alleged in the
complaint. Within 30 days of the receipt of such complaint, the Secre-
tary shall complete such investigation and shall notify in writing the
complainant (and any person acting on behalf of the complainant)
and the person alleged to have committed such violation of the results
of the investigation conducted pursuant to this paragraph. Within
ninety days of the receipt of such complaint the Secretary shall, imless
the proceeding on the complaint is terminated by the Secretary on the
basis of a settlement entered into by the Secretary and the person
alleged to have committed such violation, issue an order either pro-
viding the relief prescribed by subparagraph (B) or denying the
complaint. An order of the Secretary shall be made on the record after
notice and opportunity for agency hearing. The Secretarv may not
enter into a settlement terminating a proceeding on a complaint with-
out the participation and consent of the complainant.

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT.

such person to reinstate the complainant to the complainant's former
position together with the compensation (including back pay), terms,
conditions, and privileges of the complainant's employment, (lii) com-
pensatory damages, and (iv) where appropriate, exemplary damag;es.
If such an order issued, the Secretary, at the request of the complain-
ant, shall assess against the person against whom the order is issued a
sum equal to the aggregate amount of all costs and expenses (including
attorney's fees) reasonably incurred, as determined by the Secretary,
by the complainant for, or in connection with, the bringing of the com-
plaint upon which the order was issued.

(c) Review. — (1) Any employee or employer adversely affected or
aggrieved by an order issued under subsection (b) may obtain review
of the order in the United States Court of Appeals for the circuit in
which the violation, with respect to which the order was issued,
allegedly occurred. The petition for review must be filed within sixty
days from the issuance of the Secretar>''s order. Review shall conform
to chapter 7 of title 5 of the United States Code.

(2) An order of the Secretary, with respect to which review could
have been obtained under paragraph (1), shall not be subject to
judicial review in any criminal or other civil proceeding.

(d) Enforcement. — Whenever a person has failed to comply with Gvil action,
an order issued under subsection (b)(2), the Secretary shall file a civil

action in the United States district court for the district in which the
violation was found to occur to enforce such order. In actions brought Jurisdiction,
under this subsection, the district courts shall have jurisdiction to
grant all appropriate relief, including injunctive relief and compensa-
tory and exemplary damages. Civil actions brought under this sub-
section shall be heard and decided expeditiously.

(e) Exclusion. — Subsection (a) of this section shall not apply with
respect to any employee who, acting without direction from the
employee's employer (or any agent of the employer), deliberately
causes a violation of any requirement of this Act.

SEC. 24. EMPLOYMENT EFFECTS.

(a) In General. — ^The Administrator shall evaluate on a continuing Evaluation,
basis the potential effects on employment (including reductions in 15 USC 2623
employment or loss of employment from threatened plant closures)

of —

(1) the issuance of a rule or order under section 4, 5, or 6, or

(2) a requirement of section 5 or 6.

(b) (1) Investigations. — Any employee (or any representative of
an employee) may request the Administrator to make an investigation
of —

(A) a discharge or layoff or threatened discharge or layoff of
the employee, or

(B) adverse or threatened adverse effects on the employee's
employment,

allegedly resulting from a rule or order under section 4, 5, or 6 or a
requirement of section 5 or 6. Any such request shall be made in writ-
ing, shall set foith with reasonable particularity the grounds for the
request, and shall be signed by the employee, or representative of such
employee, making the request.

(2) (A) Upon receipt of a request made in accordance with para- Public hearings
graph (1) the Administrator shall (i) conduct the investigation
requested, and (ii) if requested by any interested person, hold public
hearings on any matter involved in the investigation unless the Admin-
istrator, by order issued within 45 days of the date such hearings are

90 STAT. 2046

PUBLIC LAW 94-469~0CT. 11, 1976

Notification.

Publication in
Federal Register.

Recommenda-
tions.

15 use 2624.

Submittal to
Congress.
GAO review.

Consultation.

Report to
Congress.

15 use 2625.

requested, denies the request for the hearings because the Adminis-
trator determines there are no reasonable grounds for holding such
hearings. If the Administrator makes such a determination, the
Administrator shall notify in writing the person requesting the hear-
ing of the determination and the reasons therefor and shall publish the
determination and the reasons therefor in the Federal Register.

(B) If public hearings are to be held on any matter involved in an
investigation conducted under this subsection —

(i) at least five days' notice shall be provided the person mak-
ing the request for the investigation and any person identified in
such request,

(ii) such hearings shall be held in accordance with section
6(c) (3), and

(iii) each employee who made or for whom was made a request
for such hearings and the employer of such employee shall be
required to present information respecting the applicable matter
referred to in paragraph (1)(A) or (1) (B) together with the
basis for such information.

(3) Upon completion of an investigation under paragraph (2), the
Administrator shall make findings of fact, shall make such recom-
mendations as the Administrator deems appropriate, and shall make
available to the public such findings and recommendations.

(4) This section shall not be construed to require the Administrator
to amend or repeal any rule or order in effect under this Act.

SEC. 25. STUDIES.

(a) Indemnification Study.— The Administrator shall conduct a
study of all Federal laws administered by the Administrator for the
purpose of determining whether and unaer what conditions, if any,
indemnification should be accorded any person as a result of any action
taken by the Administrator under any such law. The studjr shall —

(1) include an estimate of the probable cost of anymdemnifica-
tion programs which may be recommended ;

(2) include an examination of all viable means of financing the
cost of any recommended indemnification ; and

(3) be completed and submitted to Congress within two years
from the effective date of enactment of this Act.

The General Accounting Office shall review the adequacy of the study
submitted to Congress pursuant to paragraph (3) and shall report the
results of its review to the Congress within six months of the date
such study is submitted to Congress.

(b) Classification, Storage, and Retrieval Study. — The Council
on Environmental Quality, in consultation with the Administrator,
the Secretary of Health, Education, and Welfare, the Secretary of
Commerce, and the heads of other appropriate Federal departments or
agencies, shall coordinate a study of the feasibility of establishing (1)
a standard classification system for chemical substances and related
substances, and (2) a standard means for storing and for obtaining
rapid access to information respecting such substances. A report on
such study shall be completed and submitted to Congress not later than
18 months after the effective date of enactment of this Act.

SEC. 26. ADMINISTRATION OF THE ACT.

(a) Cooperation of Federal Agencies. — Upon request by the
Administrator, each Federal department and agency is authorized —
(1) to make its services, personnel, and facilities available
(with or without reimbursement) to the Administrator to assist
the Administrator in the administration of this Act; and

PUBLIC LAW 94-469— OCT. 11, 1976 90 STAT. 2047

(2) to furnish to the Administrator such information, data,
estimates, and statistics, and to allow the Administrator access to
all information in its possession as the Administrator may reason-
ably determine to be necessary for the administration of this Act.

(b) Fees. — (1) The Administrator may, by rule, require the pay-
ment of a reasonable fee from any person required to submit data
under section 4 or 5 to defray the cost of administering this Act. Such
rules shall not provide for any fee in excess of $2,500 or, in the case of
a small business concern, any fee in excess of $100. In setting a fee
under this paragraph, the Administrator shall take into account the
ability to pay of the person required to submit the data and the cost
to the Administrator of reviewing such data. Such rules may provide
for sharing such a fee in any case in which the expenses of testing are
shared under section 4 or 5. -

(2) The Administrator, after consultation with the Administrator Consultation,
of the Small Business Administration, shall by rule prescribe stand- ^^f^-
ards for determining the persons which qualify as small business
concerns for purposes of paragraph (1).

(c) Action With Respect to Categories. — (1) Any action author-
ized or required to be taken by the Administrator under any provision
of this Act with respect to a chemical substance or mixture may be
taken by the Administrator in accordance with that provision with
respect to a category of chemical substances or mixtures. Whenever
the Administrator takes action under a provision of this Act with
respect to a category of chemical substances or mixtures, any reference
in this Act to a chemical substance or mixture (insofar as it relates
to such action) shall be deemed to be a reference to each chemical
substance or mixture in such category.

(2) For purposes of paragraph ( 1 ) : Definitions.

(A) The term "category of chemical substances" means a group
of chemical substances the members of which are similar in molec-
ular structure, in physical, chemical, or biological properties, in
use, or in mode of entrance into the human body or into the
environment, or the members of which are in some other way suit-
able for classification as such for purposes of this Act, except that
such term dees not mean a group of chemical substances which are
grouped together solely on the basis of their being new chemical
substances.

(B) The term "category of mixtures" means a group of mix-
tures the members of which are similar in molecular structure, in
physical, chemical, or biological properties, in use, or in the mode
of entrance into the human body or into the environment, or the
members of which are in some other way suitable for classification
as such for purposes of this Act.

(d) Assistance Office. — The Administrator shall establish in the Establishment.
Environmental Protection Agency an identifiable office to provide
technical and other nonfinancial assistance to manufacturers and
processors of chemical substances and mixtures respecting the require-
ments of this Act applicable to such manufacturei^ and processors, the

policy of the Agency respecting the application of such requirements
to such manufacturers and processors, and the means and methods by
which such manufacturers and processors may comply with such
requirements.

(e) Financial Disclosures. — (1) Except as provided under para- ,
graph (3), each officer or employee of the Environmental Protection
Agency and the Department of Health, Education, and Welfare who —

(A) performs any function or duty under this Act, and

90 STAT^2048 PUBLIC LAW 94-469— OCT. 11, 1976

(B) has any known financial interest (i) in any person subject
to this Act or any rule or order in effect under this Act, or (ii) in
any person who applies for or receives any grant or contract under
this Act,

shall, on February 1, 1978, and on February 1 of each year thereafter,
file with the Administrator or the Secretary of Health, Education, and
Welfare (hereinafter in this subsection referred to as the "Secre-
tary") , as appropriate, a written statement concerning all such inter-
ests held by such officer or employee during the preceding calendar
year. Such statement shall be made available to the public.

(2) The Administrator and the Secretai-y shall —

(A) act within 90 days of the effective date of this Act —

(i) to define the term "known financial interests" for pur-
poses of paragraph ( 1) , and

(ii) to establish the methods by which the requirement to
file written statements specified in paragraph (1) will be
monitored and enforced, including appropriate provisions for
review by the Administrator and the Secretary of such state-
ments; and

Report to (B) report to the Congress on June 1, 1978, and on June 1 of

Congress. e&ch. year thereafter with respect to such statements and the

actions taken in regard thereto during the preceding calendar

year.

(3) The Administrator may by rule identify specific positions with
the Environmental Protection Agency, and the Secretary may by rule
identify specific positions with the Department of Health, Education,
and Welfare, which are of a nonregulatory or nonpolicymaking
nature, and the Administrator and the Secretary may by rule provide
that officers or employees occupying such positions shall be exempt
from the requirements of paragraph (1).

(4) This subsection does not supersede any requirement of chapter
11 of title 18, United States Code.

Penalty. (5) Any officer or employee who is subject to, and knowingly vio-

lates, this subsection or any rule issued thereunder, shall be fined not
more than $2,500 or imprisoned not more than one year, or both.

(f) Statement of Basis and Purpose. — Any final order issued
under this Act shall be accompanied by a statement of its basis and
purpose. The contents and adequacy of any such statement shall not
be subject to judicial review in any respect.

Appointment. (g) ASSISTANT ADMINISTRATOR. — (1) The President, by and witli

the advice and consent of the Senate, shall appoint an Assistant
Administrator for Toxic Substances of the Environmental Protection
Agency. Such Assistant Administrator shall be a qualified individual
who is, by reason of background and experience, especially qualified
to direct a program concerning the effects of chemicals on human
health and the environment. Such Assistant Administrator shall be
responsible for (A) the collection of data, (B) the preparation of
studies, (C) the making of recommendations to the Administrator for
regulatory and other actions to carry out the purposes and to facili-
tate the administration of this Act, and (D) such other functions as
the Administrator may assign or delegate.

(2) The Assistant Administrator to be appointed under paragraph
(1) shall (A) be in addition to the Assistant Administrators of the
Environmental Protection Agency authorized by section 1(d) of Reor-

5 use app. II. ganization Plan No. 3 of 1970, and (B) be compensated at the rate of
pay authorized for such Assistant Administrators.

PUBLIC LAW 94-469— OCT. 11, 1976

90 STAT. 2049

EC. 27. DEVELOPMENT AND EVALUATION OF TEST METHODS.

(a) In Gener.\l. — The Secretary of Health, Education, and Welfare,
n consultation with the Administrator and acting through the Assist-
nt Secretary for Health, may conduct, and make grants to public and
onprofit private entities and enter into contracts with public and
•rivate entities for, projects for the development and evaluation of
nexpensive and efficient methods (1) for determining and evaluating
he healtli and environmental effects of chemical substances and mix-
ures, and their toxicity, persistence, and other characteristics which
ffect health and the environment, and (2) which may be used for the
development of tost data to meet the requirements of rules promulgated
nder section 4. The Administrator shall consider such methods in
>rescribing under section 4 standards for the development of test data.

(b) Approval by Secretary. — No grant may be made or contract
ntered into under subsection (a) unless an application therefor has
•een submitted to and approved by the Secretary. Such an application
hall be submitted in such form and manner and contain such informa-
ion as the Secretary may require. The Secretary may apply such
onditions to grants and contracts under subsection (a) as the Secre-
ary determines are necessary to carry out the purposes of such subsec-
ion. Contracts may be entered into under such subsection without
egard to sections 3648 and 3709 of the Revised Statutes (31 U.S.C.
'39; 41 U.S.C. 5).

(c) Annual Reports. — (1) The Secretary shall prepare and sub-
ait to the President and the Congress on or before January 1 of each
'ear a report of the number of grants made and contracts entered into
mder this section and the results of such grants and contracts.

(2) The Secretary shall periodically publish in the Federal Register
eports describing the progress and results of any contract entered
nto or grant made under this section.
>EC. 28. STATE PROGRAMS.

(a) In General. — For the purpose of complementing (but not reduc-
ng) the authority of, or actions taken by, the Admmistrator under
his Act, the Administrator may make grants to States for the estab-
ishment and operation of programs to prevent or eliminate unreason-
ble risks within the States to health or the environment which are asso-
iated with a chemical substance or mixture and with respect to which
he Administrator is unable or is not likely to take action under this
Let for their prevention or elimination. The amount of a grant under
his subsection shall be determined by the Administrator, except that
lo grant for any State program may exceed 75 per centum of the
istablishment and operation costs (as determined by the Admin-
strator) of such program during the period for which the grant is
Qade.

(b) Approval by Administrator. — (1) No grant may be made under
ubsection (a) unless an application therefor is submitted to and
approved by the Administrator. Such an application shall be sub-
nitted in such form and manner as the Administrator may require and
ihall—

(A) set forth the need of the applicant for a grant under subsec-
tion (a),

(B) identify the agency or agencies of the State which shall
establish or operate, or both, the program for which the applica-
tion is submitted,

G>nsultation.
15 use 2626.

Grants or
contracts,
application.

Report to
President and
G)ngress.

Publication in
Federal Register.

15 use 2627.

Grants,
application.

90 STAT. 2050 PUBLIC LAW 94-469— OCT. 11, 1976

(D) contain or be supported by assurances satisfactory to the
Administrator that such program shall, to the extent feasible,
be integrated with other programs of the applicant for environ-
mental and public health protection,

(E) provide for the making of such reports and evaluations
as the Administrator may require, and

(F) contain such other information as the Administrator may
prescribe.

Application (2) The Administrator may approve an application submitted in

approval. accordance with paragraph (1) only if the applicant has established to

the satisfaction of the Administrator a priority need, as determined
under rules of the Administrator, for the grant for which the appli-
cation has been submitted. Such rules shall take into consideration the
seriousness of the health effects in a State which are associated with
chemical substances or mixtures, including cancer, birth defects, and
gene mutations, the extent of the exposure in a State of human beings
and the environment to chemical substances and mixtures, and the
extent to which chemical substances and mixtures are manufactured,
processed, used, and disposed of in a State.
Report to (c) Annual Reports. — Not later than six months after the end of

Congress. each of the fiscal years 1979, 1980, and 1981, the Administrator shall

submit to the Congress a report respecting the programs assisted by
grants under subsection (a) in the preceding fiscal year and the extent
to which the Administrator has disseminated information respecting
such programs.

(d) Authorization. — For the purpose of making grants under
subsection (a) there are authorized to be appropriated $1,500,000 for
the fiscal year ending September 30, 1977, $1,500,000 for the fiscal year
ending September 30, 1978, and $1,500,000 for the fiscal year ending
September 30, 1979. Sums appropriated under this subsection shall
remain available until expended.
SEC. 29. AUTHORIZATION FOR APPROPRIATIONS.
15 use 2628. There are authorized to be appropriated to the Administrator for

purposes of carrying out this Act (other than sections 27 and 28 and
subsections (a) and (c) through (g) of section 10 thereof) $10,100,000
for the fiscal year ending September 30, 1977, $12,625,000 for the fiscal
year ending September 30, 1978, $16,200,000 for the fiscal year ending
September 30, 1979. No part of the funds appropriated under this
section may be used to construct any research laboratories.
SEC. 30. ANNUAL REPORT.
Report to The Administrator shall prepare and submit to the President and

President and ^j^^ Congress on or before January 1, 1978, and on or before January 1
?iisr*9fi5>Q ^^^^ succeeding year a comprehensive report on the administration

5 UbL 2629. ^^^-^ during the preceding fiscal year. Such report shall include —

(1) a list of the testing required under section 4 during the year
for which the report is made and an estimate of the costs incurred
during such year by the persons required to perform such tests;

(2) the number of notices received during such year under
section 5, the number of such notices received during such year
under such section for chemical substances subject to a section 4
rule, and a summary of any action taken during such year under
section 5(g);

(3) a list of rules issued during such year under section 6 ;

(4) a list, with a brief statement of the issues, of completed or
pending judicial actions under this Act and administrative actions
under section 16 during such year ;

PUBLIC LAW 94^9— OCT. 11, 1976 90 STAT. 2051

(5) a summary of major problems encountered in the adminis-
tration of this Act ; and

(6) such recommendations for additional legislation as the Recommenda-
Administrator deems necessary to carry out the purposes of this

Act.

SEC 31. EFFECTIVE DATE.

Eixcept as provided in section 4(f), this Act shall take effect on 15 USC 2601
January 1, 1977. °ote.

Approved October 11, 1976.

LEGISLATIVE HISTORY:

HOUSE REPORTS: No. 94-1341 accompanying H.R. 14032 (Comm. on Interstate and

Foreign Commerce) and No. 94-1679 (Comm. of Conference).
SENATE REPORTS: No. 94-698 (Comm. on Commerce) and No. 94-1302 (Comm. of

Conference).
CONGRESSIONAL RECORD, Vol. 122 (1976):
Mar. 26, considered and passed Senate.

Aug. 23, considered and passed House, amended, in lieu of H.R. 14032.
Sept. 28, Senate and House agreed to conference report.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 12, No. 42:
Oct. 12, Presidential statement.

Note. — A change has been made in the slip law format to provide for one-time
preparation of copy to be used for publication of both slip laws and the United
States Statutes at Large volumes. Comments from users are invited by the Office of
the Federal Register, National Archives and Records Service, Washington, D.C.
20408.

(Excerpt from Weekly Compilation of Presidential Documents, vol. 12, No. 42. Oct. 18,

1976, p. 1489]

Statement of the President on Signing S. 3149 Into Law —

October 12, 1976

I have signed S. 3149, the Toxic Substances Control Act. I believe
this legislation may be one of the most important pieces of environ-
mental legislation that has been enacted by the Congress.

This toxic substances control legislation provides broad authority to
regulate any of the tens of thousands of chemicals in commerce. Only
a few of these chemicals have been tested for their long-term effects on
human health or the environment. Through the testing and reporting
requirements of the law% our understanding of these chemicals should
be greatly enhanced. If a chemical is found to present a danger to
health or the environment, appropriate regulatory action can be taken
before it is too late to undo the damage.

The legislation provides that the Federal Government through the
Environmental Protection Agency may require the testing of selected
new chemicals prior to their production to determine if they will pose
a risk to health or the environment. Manufacturers of all selected new
chemicals w411 be required to notify the Agency at least 90 days before
commencing commercial production. The Agency may promulgate
regulations or go into couit to restrict the production or use of a chem-
ical or to even ban it if such drastic action is necessary.

The bill closes a gap in our current array of laws to protect the
health of our people and the environment. The Clean Air Act and the
Water Pollution Control Act protect the air and water from toxic
contaminants. The Food and Drug Act and the Safe Drinking Water
Act are used to protect the food we eat and the water we drink against
hazardous contaminants. Other provisions of existing laws protect
the health and the environment against other polluting contaminants
such as pesticides and radiation. However, none of the existing stat-
utes provide comprehensive protection.

This bill provides broad discretionary authority to protect the health
and environment. It is critical, however, that the legislation be admin-
istered in a manner so as not to duplicate existing regulatory and en-
forcement authorities.

In addition, I am certain that the Environmental Protection Agency
realizes that it must carefully exercise its discretionary authority so
as to minimize the regulatory burden consistent with the effective pro-
tection of the health and environment.

The administration, the majority and minority members of the
Congress, the chemical industry, labor, consumer, environmental, and
other groups all have contributed to the bill as it has finally been
enacted. It is a strong bill and will be administered in a way which
focuses on the most critical environmental problems not covered by
existing legislation while not overburdening either the regulatory
agency, the regulated industry, or the American people.

(53)

CHAPTER II

S. 3149 TOGETHER WITH REPORT AND DEBATE

Note. — S. 3149 was introduced as a clean bill: the original bill on which
hearings were held was S. 776.

94Tn CONGUESS
2d Session

Calendar No. 668

S. 3149

[Report No. 94-698]

IN THE SENATE OF THE UNITED STATES

March 16, 1976

Mr. TuNNEY (for himself and Mr. IIartke) introduced the following bill;
which was read twice and referred to the Committee on Commerce

March 16,1976
Reported by Mr. Tunxev, without amendment

A BILL

To regulate commerce and protect human health and the envh-on-
ment by requiring testing and necessary use restrictions on
certain chemical substances, and for other purposes.

1 Be it enacted by the Senate and House of Representa-

2 tives of the United States of America in Congress assembled,

3 SIIOET TITLE AND TABLE OF CONTENTS

4 Section 1. This Act may be cited as the ''Toxic Sub-

5 stances Control Act".

TABLE OF CONTENTS

Sec. 1. Short title and table of contents.

Sec. 2. Findings, policy, and intent.

Sec. 3. Definitions and exclusions.

Sec. 4. Testing of chemical substances and mixtures.

Sec. 5. Premarket notification of chemical substances.

Sec. 6. Regulation of chemical substances and mixtures.

Sec. 7. Imminent hazards.

Sec. 8. Reporting and retention of information.

TABLE OF CONTENTS— Continued

Sec.

9. Relationship to other Federal laws.

Sec.

10.

Research, collection, dissemination, and utilization of data.

Sec.

11.

Inspections.

Sec.

12.

Exports.

Sec.

13.

Entry into customs territory of the United States.

Sec.

14.

Disclosure of data.

Sec.

15.

Prohibited acts.

Sec.

16.

Penalties.

Sec.

17.

Specific enforcement and seizure.

Sec.

18.

Preemption.

Sec.

19.

Judicial review.

Sec.

20.

Citizen's civil action.

Sec.

21.

Citizen's petitions.

Sec.

22.

National defense waiver.

Sec.

23.

Employee protection.

Sec.

24.

Studies.

Sec.

25.

Administration of Act.

Sec.

26.

Authorization for appropriations.

Sec.

27.

Aimual report.

1 FINDINGS, POLICY, AND INTENT

2 Sec. 2. (a) Findings— The Congress finds that—

3 ( 1 ) humans and the environment are being ex-

4 posed to a large number of chemical substances and

5 mixtures each year;

6 (2) among the many chemical substances and mix-

7 tures constantly being developed and produced are some

8 whose manufacture, processing, distribution in com-

9 merce, use, or disposal may cause or contribute to an

10 unreasonable risk of injury to health or the environ-

11 ment; and

12 (o) the effective regulation of such chemical sub-

13 - stances and mixtures in interstate commerce necessitates
■^^ the regulation of such chemical substances and mixtures

in intrastate commerce as well.

1 (b) Policy.— It is the policy of the United States

2 that—

3 (1) adequate data should be developed with re-

4 spect to chemical substances and mixtures concerning

5 their effect on human health and the environment and

6 that such data development should be die responsibil-

7 ity of those who manufacture and those who process

8 such chemical substances and mixtures ;

9 (2) adequate authority should exist to regulate

10 chemical substances and mixtures which cause or con-

11 tribute to an unreasonable risk of injury to health or the

12 environment, and to take action with respect to chemical

13 substances and mixtures Avhich are imminent hazards;

14 and

15 (3) authority over chemical substances and mix-

16 tures should be exercised m such a manner as not to

17 impede unduly or create unnecessary economic barriers

18 to technological innovation while fulfilling the primary

19 purpose of tliis Act to ass,ure that such innovation and

20 commerce in such chemical substances and mixtures do

21 not cause or contribute <to an unreasonable risk of injury

22 to health or the environment.

23 (c) Intent of Congress.— It is the intent of Con-

24 gross that the Administrator shall carry out this Act in a

25 reasonable and prudent manner, and that the Administrator

1 stall consider the environmental, economic, and social impact

2 of any action the Administrator takes or proposes to take

3 under this Act.

4 DEFINITIONS AND EXCLUSIONS

5 Sec. 3. (a) Definitions— As used in this Act:

6 (1) The term ''Administrator" means the Administra-

7 tor of the Environmental Protection Agency.

8 (2) (A) Except as provided in suhparagraph (B), the

9 term "chemical substance" means —

10 (i) any organic or inorganic substance of a par-

11 ticular molecular identity including a combination of

12 such substances occ.urring as a result of a chemical

13 reaction, or

14 (ii) any element or uncombined radical.

15 (B) Such term does not include —

16 (i) any mixture,

17 (ii) any pesticide (as defined in the Federal In-

18 secticide. Fungicide and Rodenticide Act) when manu-

19 factured or distributed in commerce for use as a pesti-

20 cide,

21 (iii) tobacco or any tobacco product,

22 (iv) any source material, special nuclear material,

23 or byproduct material (as such terms are defined in the

24 Atomic Energy Act of 1954 and regulations issued under

25 such Act) ,

1 (v) any article which, if sold by the manufacturer,

2 would be subject to the tax imposed by section 4181 of

3 the Internal Revenue Code of 1^54 (determined without

4 regard to any exemptions from such tax provided by sec-

5 tion 4182 or 4221 or any other provision of such Code) ,

6 and

7 (vi) any substance found in or on any food, or

8 any drug, cosmetic, or device (as such terms are de-

9 fined in section 201 of the Federal Food, Drug, and

10 Cosmetic Act) when (A) manufactured or distributed

11 in commerce for use in or on any such food, or as any

12 such drug, cosmetic, or device, or (B) produced for

13 research and development purposes and intended only

14 for use in or on any such food, or as any such drug,

15 cosmetic, or device.

16 The term ''food" as used in clause (vi) of this subparagraph

17 includes poultry and poultry products (as defined m sections

18 4 {e) and 4(f) of the Poultry Products Inspection Act),

19 meat and meat food products (as defined in section 1 (j) of

20 the Federal Meat Inspection Act) , and eggs and egg prod-

21 ucts (as defined in section 4 of the Egg Products Inspection

22 Act).

23 (3) The term ''commerce" means trade, traffic, or trans-

24 portation (A) between a place in a State and any place

1 outside of such State, or (B) which affects such trade,

2 traffic, or transportation.

3 (4) The term ''distribute in commerce" or "distribu-

4 tion in commerce" when used to describe an action taken

5 with respect to a chemical substance or mixture means to

6 sell, or the sale of, the substance or mixture; to introduce or

7 deliver for introduction into commerce, or the introduction or

8 delivery for introduction into commerce of, the substance or

9 mixture; or to hold, or the holding of, the substance or

10 mixture after its introduction into conmierce.

11 (5) The term "environment" includes humans and

12 their environment, water, atmosphere, and land and the

13 interrelationships which exist among and between these.

11 (6) The term ''health and safety study" means any
study of any effects of a chemical substance or mixture on

1^ health or the environment, including epidemiological studies,

1' studies of occupational exposure to a chemical substance bt
mixture, toxicological, clinical, and ecological studies of a

1^ chemical sul^stance or mixture, and any test perforaicd pur-

-0 suant to this Act.

^1 (7) The term "manufacture" means to import, produce,

or manufacture for commercial purposes.

(8) The term "mixture" means any combination of two
^4 or more clieniicnl substances if such su))stances (A) do not

1 react chemically with each other and if the combination is not

2 the result of a chemical reaction, or (B) occur in nature.

3 (9) The term ''new chemical substance" means any

4 chemical substance not included in the chemical substance

5 hst compiled and published under section 8 (b) .

6 (10) The term ''process" means the preparation of a

7 chemical subsUuice or mixture for distribution in commerce —

8 (A) in the same form or physical state, or in a

9 different form or physical state from that m which it

10 was received by the person making such preparation, or

11 (B) as part of an article containing the chemical

12 substimce or mixture.

13 (11) The tei-m "processor" means any person who

14 processes a chemical substance or mixture.

IT) (12) The temi "standards for the development of test
datii" means a prescription of —

17 . (A) the—

18 (i) health and environmental effects, and

19 (ii) ty]3e of information relating to toxicity,

20 persistence, and other characteristics w'hich relate to

21 effects on health and the environment

22 for which test data for a chemical substance or mixture

23 are to be developed and any analysis that is to be per-

24 fonned on such data, and

1 (B) to the extent necessary to assure that such data

2 are reliable and adequate, the manner in w*hich such

3 data are to be developed, the specification of any test

4 protocol or methodology to be employed in the develop-

5 ment of data respecting such effects and characteristics,
Q and such other requirements as are necessary to provide

7 such assurance.

8 (13) The term ^'State" means any of^the several

9 States, the District of Columbia, the Commonwealth of

10 Puerto Eico, the Virgin Islands, Guam, the Canal Zone,

11 American Samoa, or the Trust Territory of the Pacific

12 Islands.

13 (14) The term "United States", when used in the

14 geogi'aphic sense, means all the States.

15 (b) Exclusions.— The Administrator may exclude

16 from coverage of this Act or any provision of this Act any

17 chemical substance or mixture if the Administrator deter-

18 mines, by rule, that such substance or mixture does not

19 present an unreasonable risk of injury to health or the

20 environment, except that any such exclusion shall not apply

21 to section 7 or 8(e). Any such rule shall (A) be pro-

22 mulgated pursuant to the procedures specified in section

23 6(c) (2), (3), (4), and (5) and (B) may be modified,

24 amended, or revoked in accordance with the requirements

1 of this subsection and pursuant to the procedures specified

2 in such section 6(c) (2), (3), (4), and (5).

3 TESTING OF CHEMICAL SUBSTANCES AND MIXTURES

4 Sec. 4. (a) Testing Eequirements .— If the Ad-

5 ministrator finds that —

6 (1) (A) (i) the manufacture, processing, distribu-

7 tion in commerce, use, or disposal of a chemical sub-

8 stance or mixture may present an unreasonable risk of

9 injury to health or the environment, or (ii) (I) that the

10 manufacture, processing, distribution in commerce, use,

11 or disposal of a chemical substance or mixture may

12 present significant human or environmental exposure

13 because it is or will be produced in substantial quantities

14 or for other reasons, and (II) that such substance or

15 mixture may perhaps present an adverse effect on health

16 or the environment,

17 " (^) there are insufficient data or experience upon

18 which the effects of such manufacture, processing, dis-

19 tribution in commerce, use, or disposal on health or

20 the environment can reasonably be determined or pre-

21 dieted, and

22 (C) testing of such substance or mixture with

23 respect to such effects is necessary to develop such data ;

24 and

1 (2) in the case of a mixture, the effects which the

2 mixture's manufacture, distribution in commerce, proc-

3 essing, use, or disposal may have on health or the en-

4 vironment may not be reasonably and more eflSciently

5 determined or predicted by testing the chemical sub-

6 stances which comprise the mixture ;

7 the Administrator shall by rule require that testing be con-

8 ducted on such substance or mixture to develop data with

9 respect to the health and environmental effects for which

10 there is an insuffidency of data or experience and which

11 are relevant to a determination that the manufacture, distri-

12 bution in commerce, processing, use, or disposal of such

13 substance or mixture does or does not cause or contribute to

14 an unreasonable risk of injuiy to health or the environment.

15 In requiring tests under this subsection, the Administrator

16 shall consider the reasonably ascertainable costs and other

17 burdens associated with conducting such tests in light of the

18 possible risks of injury to health or the environment and shall
IP publish the same in the Federal Register. The finding in

20 paragraph (1) (A) (ii) (II) shall be presumed if the Ad-

21 ministrator has no reliable data or experience available to

22 him concerning the chemical substance or mixture. The find-

23 ing in paragraph (1) (A) (ii) (11) shall not be subject to

24 judicial review on any ground other than the fact that such

25 finding was not made.

1 (b) (1) Testing Requirement Eule— A rule under

2 subsection (a) requiring the testing of a chemical substance

3 or mixture shall include —

4 (A) identification of the substance or mixture for

5 which testing is required,

6 (B) standards for the development of test data for

7 such substance or mixture, and

8 (C) with respect to chemical substances which are

9 not new chemical substances a specification of the period

10 (which period may not be of unreasonable duration)

11 within which the persons required to conduct the testing

12 shall submit to the Administrator data developed in

13 accordance with the standards referred to in subpara-

14 graph (B) .

15 Such a nile may require the submission of prehminary data

16 during the period prescribed under subparagraph (C).

17 (2)" (A) The health and environmental effects for which

18 standards for tlie development of test data may be pre-

19 scribed include carcinogenesis, mutagenesis, teratogenesis,

20 behavioral disorders, cumulative or synergistic effects, and

21 any other effect which may cause or contribute to an unrea-

22 sonable risk of injury to health or the environment, and the

23 characteristics of chemical substances and mixtures for which

24 such standards may be prescribed include persistence, acute

25 toxicity, subacute toxicity, chronic toxicity, and any other

1 characteristic whicli may cause or contribute to such a risk

2 of injury. The methodologies that may be prescribed in such

3 standards include epidemiology, serial, or hierarchical tests;

4 in vitro tests; and whole animal tests.

5 (B) From time to time, but not less than once each
ft'

6 12 months, the Administrator shall review the adequacy

7 of the standards for development of data prescribed in rules

8 under subsection (a) and shall, if necessary, institute pro-

9 ceedings to make appropriate revisions of such standards.

10 (3) (A) A rule under subsection (a) respecting a

11 chemical substance or mixture shall require the persons

12 described in subparagraph (B) to conduct tests and submit

13 data on such substance or mixture, except that the Admin-

14 istrator may permit t^vo or more of such persons to designate

15 one such person or a qualified third party to conduct such

16 tests and submit such data on behaK of the persons making

17 the designation.

18 (B) The following persons shall be required to conduct

19 tests and submit data on a chemical substance or mixture

20 subject to a rule under subsection (a) :

21 (i) Each person who manufactures or intends to

22 manufacture such substance or mixture if the Adminis-

23 trator made a finding described in subsection (a) (1)

24 (B) with respect to the manufacture of the substance

1 or mixture which such person is engaged in or intends

2 to engage in.

3 (ii) Each person who processes or intends to process

4 such substance or mixture if the Administrator made a

5 finding described in subsection (a) (1) (B) with respect

6 to the processing of the substance which such person

7 is engaged in or intends to engage in.

8 (iii) Each person who manufactures or processes or

9 intends to manufacture or process such substance or mix-

10 tui'e if, with respect to the distribution in commerce, dis-

11 posal or use of such substance or mixture manufactured

12 or processed or to be manufactured or processed by such

13 person, the Administrator made a finding described in

14 subsection (a) (1) (B).

15 (4) Rules issued under subsection (a) (and any amend-

16 ment thereto or repeal thereof) shall be promulgated pur-

17 suant to section 553 of title 5, United States Code, except

18 that in promulgating, amending, or repealing any such rule

19 (A) the Administrator shall give interested persons an op-

20 portunity for the oral presentation of data, views, or argu-

21 ments, in addition to an opportunity to make written sub-

22 missions; and (B) a transcript shall be made of any oral

23 presentation.

24 (c) Exemption. — (1) Any person required by a rule

1 under subsection (a) to conduct tests and submit data on a

2 chemical substance or mixture may apply to the Adminis-

3 trator (in such form and manner as the Administrator shall

4 prescribe) for an exemption from such requuement.

5 (2) If, upon receipt of an application under paragraph

6 ( 1 ) , the Administrator determines that —

7 (A) the chemical substance or mixture with respect

8 to which such application was submitted is equivalent

9 to a chemical substance or mixtm'e for which data has

10 been submitted to the Administrator in accordance with

11 a rule under subsection (a) or for which data is being

12 developed pursuant to such a rule, and

13 (B) submission of data by the applicant on such

14 substance or mixture would be duplicative of data which

15 has been submitted to the Administrator in accordance

16 with such rule or which is being developed pursuant to

17 such rule,

18 the Administrator shall exempt, in accordance with para-

19 graph (3) or (4), the apphcant from conducting tests and

20 submitting data on such substance or mixture.

21 (3) (A) If the exemption of any person from the re-

22 quirement to conduct tests and submit test data on a chemical

23 substance or mixture is granted on the basis of the existenee

24 of previously submitted tesit data and if such exemption is

1 granted d,uring the reimbursement period for such te&i data

2 (as prescribed by subparagraph (B)), then (miless such

3 person and the persons referred to in clauses (i) and (ii)

4 agree on the amount and method of reimbursement) the

5 Administrator shall order the person granted the exemption

6 to provide fair and equitable reimbursement (in an amount

7 determined under rules of the Administrator) —

8 (i) to the person who previously submitted such test

9 data, for a portion of the costs incui'red by such person

10 in complying with the requirement to submit such data,

11 and

12 (ii) to any other person who has been required

13 under this subparagraph to contribute with respect to

14 such costs, for a portion of the amount such person was

15 required to contribute.

16 In promulgating rules for the detemiination of fair and

17 equitable reimbursement to the persons described in clauses

18 (i) and (ii) for costs incurred with respect to a chemical

19 substance or mixture, the Administrator shall, after consul-

20 tation with the Attorney General and the Federal Trade

21 Commission, consider all relevant factors, including the

22 effect on competition within the chemical industiy and the

23 share of the market for such substance or mixture of the

24 person required to provide reimbursement in relation to the

1 share of such market of the persons to be reimbursed. An

2 order under this subparagraph for purposes of judicial

3 review shall be considered final agency action.

4 (B) For purposes of subparagraph (A) , the reimburse-

5 ment period for any test data for a chemical substance or
Q mixture is a period —

7 (i) beginning on the date such data was submitted

g in accordance with a rule promulgated under subsection

9 (a) , and

10 (ii) ending—

11 (I) two years after the date referred to in

12 clause (i) , or

13 (II) at the expiration of a period which begins

14 on the date referred to in clause (i) and is equal to

15 the period which the Administrator determines was

16 necessary to develop such data,

17 whichever is later.

13 (4) (A) If the exemption of any person from the re-

19 quirement to conduct tests and submit test data on a chemical

20 substance or mixture is granted on the basis of the fact that

21 test data is being developed by one or more persons pursuant

22 to a rule promulgated under subsection (a) , then (unless

23 such person and the persons referred to in clauses (i) and

24 (ii) agree on the amount and method of reunbursement) the

25 Administrator shall issue an order to the person granted the

1 exemption to provide fair and equitable reimbursement (In

2 an amount determined under rules of the Administrator) —

3 (I) to each such person who is> developing such test

4 data, for a portion of the costs incurred by each such

5 person in complying with such rule, and

(J (ii) to any other person who has been required

7 under this subparagraph to contribute with respect to

8 the costs of complying with such rule, for a portion of

9 the amount such person was required to contribute.

10 In promulgating rules for the determination of fair and

11 equitable reunbursement to the persons described in clauses

12 (i) and (ii) for costs incurred with respect to a chemical

13 substance or mixture^ the Administrator shall, after consul-

14 tation with the Attorney General and the Federal Trade

15 Commission, consider all relevant factors, including the
1(5' effect on competition within the chemical industry and the

17 share - of thie market for such substance or mixtilre of the

18 person required to provide reimbursement in relsltion to the
19^ share of such market of thte persons to be reimbursed. An

20 .order under ' this subparagraph for purposes of judicial

21 review shall be considered final agency action.

22" (Sy i^ exemption' is granted on the basis of the fact

23 that one or more persons are developing test data pursuant to

24 a rule promulgated under subsection (a) and if after such
25' ' exemption is granted the Administrator determines that no

79-313 O - 77 - 6

1 such person has complied with such rule, the Administrator

2 shall (i) after providmg written notice, to the person who

3 holds such exemption and an opportunity for a hearing, by

4 order termmate such exemption, and (ii) notify in writing

5 such person of the requirements of the rule with respect to

6 which such exemption was granted.

7 (5) If a person provides reimbursement pursuant to an

8 order issued under paragraph (3) (A) or (4) (A) in con-

9 nection with an exemption from a rule promulgated under

10 subsection (a) , such person may, subject to section 14, have

11 access to test data the submission or development of which

12 was the basis for such exemption.

13 (d) Notice. — Upon the receipt of any test data pur-

14 suant to a rule under subsection (a) , the Administrator shall

15 (subject to section 14) publish a notice of the receipt of

16 such data in the Federal Register and make the data avail-

17 able to the public within 15 days of receipt. Each such

18 notice shall (1) identify the chemical substance or mixture

19 for which data have been received; (2) hst the uses or in-

20 tended uses of such substance or mixture and the information

21 required by the applicable standards for the development of

22 test data; and (3) describe the nature of the test data

23 developed.

24 (e) Peioeity List.— (1) (A) There is established

25 a committee to make recommendations to the Administrator

1 respecting the chemical substances and mixtures to which the

2 Administrator should give priority consideration for the

3 promulgation of a rule under subsection (a) . In makmg such

4 a determination with respect to any chemical substance or

5 mixture, the committee shall consider all relevant factors,

6 including —

7 (i) the quantities in which the substance or mix-

8 ture is or will be manufactured,

9 (ii) the quantities in which the substance or mixture

10 enters or will enter the environment,

11 (iii) the number of persons who are or will be

12 exposed to the substance or mixture in their places of

13 employment and the duration of such exposure,

14 (iv) the extent to which humans are or will be ex-

15 posed to the substance or mixture,

16 (v) the extent to which the substance or mixture is

17 -closely related to a chemical substance or mixture which

18 is known to cause or contribute to an unreasonable risk

19 to health or the environment,

20 (vi) the existence of data concerning the effects of

21 the substance or mixture on health or the environment,

22 and

23 (vii) the extent to which testing of the substance

24 or mixture may result in the development of data upon

25 which the effects of the substance or mixture on health

1 or the environment can reasonably be detenmned or

2 predicted.

3 The reconmiendations of the committee shall be in the form

4 of a list of chemical substances and mixtures which shall

5 be hs'ted, either by individual substance or mixtui'e or by

6 groups of substances or mixtures, in the order in which the

7 committee deteraiines the Admmistrator should take action

8 under subsection (a) with respect to the substances and

9 mixtures. The committee shall give priority attention in
30 estabhshing such list to those chemical substances and mix-

11 tures which are known or are suspected of causing or con-

12 tributing to (i) cancer, (ii) gene mutations, or (iii) birth

13 defects.

14 (B) As soon as practicable but not later than nme

15 months after the date of the enactment of this Act, the com-

16 mittee shall pubUsh in the Federal Register the Ust required

17 by subparagraph (A) together with the reasons for the com-

18 mittee 's inclusion of each chemical substance or mixture on

19 the Hst. At least every 6 months after the pubhcation of

20 the list pursuant to the preceding sentence, the committee

21 shall make such revisions in the list as it determines to be

22 necessary and shall pubhsh the list in the Federal Kegister

23 with the committee's revisions (if any) and the reasons for

24 the revisions. Within the 12-month period be^nning on the

25 date of the inclusion of a chemical substance or mixture on

1 such a list the Administrator shall with respect to such

2 chemical substance or mixture either (i) initiate a rule-

3 making proceeding under section 4 (a) or (ii) if such a

4 proceeding is not initiated within such period, publish in

5 the Federal Register the Administrator's reasons for not
Q initiating such a proceeding.

7 (C) The Administrator may promulgate a rule under

8 subsection (a) with respect to a chemical substance or mix-

9 ture (i) wliidi is not contained on a list published under

10 this subsection or (ii) whether or not the Administrator has

11 published in the Federal Register reasons for not initiating

12 a proceeding under subparagraph (B) .

12, (2) (A) The committee established by paragraph (1)

14 (A) shall consist of seven members as follows :

15 (i) One member (or designee of the member)

16 appointed from the Department of Commerce by the

17 ■ Secretary.

18 (ii) One member (or designee of the member)

19 appointed from the Environmental Protection Agency

20 by the Administrator.

21 (iii) One member (or designee of the member)

22 appomted by the Secretary of Labor from officers of

23 the Department of Labor engaged in the Secretary's

24 activities under the Occupational Safety and Health

25 Act of 1970.

1 (iv) One member (or designee of the member)

2 'appointed from the Council on Environmental Quality

3 by the Chairman of the Council.

4 (v) One member (or designee of the member)

5 appointed from the National Institute for Occupational

6 Safety and Health by the Director of the Institute.

7 (vi) One member (or the designee of the member)

8 appointed from the National Institute of Environmental

9 Health Sciences by the Director of the Institute.

10 (vii) One member (or designee of the member)

11 appointed from the National Cancer Institute by the

12 Director of the Institute. ^

13 (^iii) One member (or designee of the member)

14 appointed from the National Science Foundation by
35 the Dh'ector of the Foundation.

K) A member may designate an individual to serve on the

17 member's behalf only with the approval of the applicable

18 appomtmg authority and only if the individual is from the

19 entity from which the member was appointed. A vacancy in

20 the committee shall be filled in the same manner m which

21 the original appointment was made.

22 (^) (i) The term of office of a member of the committee

23 is 4 years, except that of the members first appointed,

24 four members shall have initial terms of 2 years. Any

79
23

1 member appointed to fill a vacancy occurring prior to the

2 expiration of the term for which the member's predecessor

3 was appointed shall be appointed only for the remainder of

4 such term. If any member of the committee leaves the office

5 or entity from which the member was appointed, such mem-
G ber's term of office shall be terminated and the member's

7 position shall be considered as being vacant. A member may

8 serve after the expiration of the member's term of office until

9 a successor has taken office. Members may be reappointed.

10 (ii) Initial appointments to the committee shall be

11 made not later than the 60th day after the date of the

12 enactment of this Act. Not later than the 90th day after

13 such date of enactment the members of the committee shall

14 hold a meeting for the selection of a chairman from among

15 their number and to determine, by lot, the four members

16 who shall have initial tenns of 2 years.

17 (C) (i) No member of the committee, or designee of

18 such member, shall accept employment or compensation

19 from any person subject to any requirement of this Act, or

20 rules issued thereunder, for a period of at least 24 months

21 after termination of employment with such agency.

22 (ii) No person, while serving as a member of such

23 committee, or designee of such member, may own any stocks

24 or bonds, or have any pecuniary interest in any firm, asso-

1 elation, or corporation engaged m the manufactiu'e, process-

2 ing, or distribution of any chemical substance or mixture

3 subject to the provisions of this Act.

4 (iii) The Administrator or the Attorney General may

5 bring an action in the appropriate district court of the United

6 States to restrain any violations of this subparagraph.

7 (D) The Administrator shall provide tiie committee

8 such administrative and stafif support services as may be

9 necessary for the committee to carry out its functions under

10 this subsection.

11 (f) Eequieed Actions. — (1) Upon tiie receipt of

12 (A) any test data required to be submitted under this secth)n

13 or under sectipn 5, or (B) any other information available to

14 the Administrator which indicates that a chemical substance

15 or mixture has the potential, at levels for which human ex-

16 posure exists or may exist and with appropriate safety mar-

17 gins, to induce in human beings (1) cancer, (2) gene

18 mutations, or (3) birth defects, the Administrator shall take

19 appropriate action under section 5 (e) , 6 (a) , or 7, within

20 180 days after the receipt of such data or information to Umit

21 exposure of human beings with respect to such substance or

22 mixture, or he shall publish m the Federal Register his find-

23 ing that no unreasonable risk of injury is presented and rea-

24 sons tiicrefor. Any such finding under this subsection that no

81
25

1 unreasonable risk is presented shall be reviewable in accord-

2 ance with chapter 7 of title 5, United States Code^

3 (2) Nothing contained in this subsection shall require

4 the Administrator to take action under section 5 (e) , 6 (a) ,

5 or 7, or publish his reasons for failing to take such action,

6 until 2 years after the date of enactment of this Act.

7 PEEMARKET NOTIFICATION OF CHEMICAL SUBSTANCES

8 Sec. 5. (a) General.— (1) Commencing 1 year and

9 30 days after the date of enactment of this Act, a

10 manufacturer shall notify the Administrator, who shall

11 notify the public as required in subsection (c) , of any

12 planned manufacture of a new ^^hemical substance, at least

13 90 days prior to the commencement of such manufacture.

14 Such notice to the Administrator shall be accompanied by

15 all pertinent information referred to in section 8(a) (2),
1^ whether or not the Administrator has required the siibmis-
1'^ sion thereof under section 8(a) (2) . except that with respect

18 to the information referred to under section 8(a) (2) (E),

19 such manufacturer may submit a description of such infor-

20 mation, as defined by the Administrator, by rule.

21 (2) The Administrator shall give priority attention to

22 a chemical substance with respect to which information is

23 received indicating that serious economic or other hardships

24 are likely to result if there is any delay in manufacture.

1 If the Administrator finds that such a substance does not

2 present an unreasonable risk to human health and the

3 environment, he may reduce the number of days, after sub-

4 mission of such infoimation, during which manufacture may

5 not occur. The Administrator shall promptly pubhsh (sub-

6 ject to section 14) his findings and the basis therefor in the

7 Federal Eegister.

8 (b) Submission of Data. — Any manufacturer of a

9 new chemical substance that is covered by section 4 (a) shall

10 submit to the Administrator (in addition to the information

11 required in subsection (a) ) the data developed in accord-

12 ance with such requirement .at least 90 days prior to such

13 manufacture, and the Administrator shall make it pubhcly

14 available in accordance with subsection (c) .

15 (c) Data Availability. — Within 15 days after re-

16 ceipt, the Administrator shall promptly publish in the Fed-

17 eral Eegister (subject to section 14) the identity of each

18 chemical substance for which a notice has been received un-

19 der subsection (a) or (b) , the intended use or distribution

20 of such substance, and a statement that the data and other

21 information is available. The 90 days referred to in subsec-

22 tions (a) and (b) shall begin upon pubHcation under this

23 subsection in the Federal Register.

24 (d) Extension. — The Administrator may extend, for

25 an additional period beyond the 90-day period referred to

1 in subsection (a) or (b) , the date after which a new chemi-

2 cal substance may be manufactured. Such additional period

3 may not exceed 90 days and shall not be imposed except

4 for good cause shown. Notice of any such extension, and

5 the reasons therefor, shall be pubhshed (subject to section

6 14) in the Federal Register. Such an extension shall consti-

7 tute a final action for purposes of judicial review.

8 (e) Ordees.— ( 1 ) (A) If the Administrator finds, dur-

9 ing the 90-day period referred to in subsection (a) or (b)

10 or during any extension thereof, with respect to any new

11 chemical substance for which notification is required under

12 this section —

13 (i) that such new chemical substance is covered by

14 a test requirement under section 4(a), but that such

15 requirement requires additions or revisions with respect
IG to such substance ; or

17 (ii) that such new chemical substance is not cov-

18 ered by such a requirement under section 4(a), but

19 that such requirement should be estabhshed;

20 he shall issue an order in accordance with this subsection.

21 Such an order shall appropriately prohibit or restrict the

22 manufacture, processing, distribution in commerce, use, or

23 disposal of such new chemical substance pending the comple-

24 tion of a rulemaking proceeding under section 4(a) and

25 the submission of any data required thereunder, as described

^ tinder sul)paragraph (B) ; shall contain a proposed rule

2 under section 4(a) ; and shall be immediately effective.

2 (B) Upon the issuance of any order under subpara-

^ gi'aph (A) , the Administrator shall proceed with a rulemak-

g ing procedure as expeditious^ as practicable under section 4

Q (a) and in accordance with subparagraph (C) . During the

rj course of, or upon the completion of, such rulemaking, the

g Administrator shall, if necessary, appropriately modify or

g rescind any order issued under subparagraph (A). If any

-^Q testing requirements are established as a result of such rule-

j^-j^ making, any proAdsion of such order restricting the manu-

■J2 facture, processing, distribution in commerce, use, or disposal

-J3 of such substance shall remain in eflfect, unless modified or

■j^^ rescinded, pending the submission of such data to the Ad-

-|5 ministrator and the completion of procedures described in

■^Q subsection (b) or any extension imposed under subsection

17 (d).

-j^g paragraph (A), the Administrator shall provide interested

2Q persons reasonable opportunity, in accordance with section

21 4(b) (4) to make presentations and submissions with re-

22 spect to such order. If such presentation or submission is

23 requested, the Administrator shall comply within 30 days

24 from the date such request is made unless the Administra-

25 tor and the person making the request agree upon a later

1 date. Within 10 days after such presentations and submis-

2 sion are concluded, the Administrator shall consider such

3 presentations and submissions and affirm, modify, or revoke

4 such order.

5 (2) (A) If the Admmistrator finds, during the 90-day

6 period referred to in subsection (a) or (b) or during any

7 extension thereof, with respect to any new chemical substance

8 for which notification is required under this section, that a

9 rule is appropriate under section 6(a), he shall issue an

10 order in accordance with this subsection, Such an order.

11 shall appropriately prescribe such requirements as are au-

12 thorized under section 6(a) ; shall contain a proposed rule

13 under section 6 (a) ; and shall be immediately effective.

1-1 (B) Upon the issuance of any order under subpara-

15 graph (A), the Administrator shall proceed with a rule-

16 making procedure as expeditiously as practicable imder sec-

17 tion 6(a) and in accordance wdth subparagraph (C) .

18 During the course of, or upon the completion of such rule-

19 making, the Administrator shall> if necessary, appropriately

20 modify or rescmd any order issued under subparagraph ( A) .

21 (C) If the Administrator issues an order under sub-

22 paragraph (A), the Administrator shall provide interested

23 persons reasonable opportunity^, in accordance with section

24 6(c) (2) and (3) for an mformal hearing wdth respect to

25 s,uch order. If such hearing is requested, the Administrator

1 shall comply within 30 days from the date such request is

2 made unless the Administrator and the person making the

3 request agree upon a later date. Within 10 days after such

4 hearing is concluded, the Administrator shall consider the

5 information presented at such hearing and affirm, modify,

6 or revoke such order.

7 (f) Statement of Reasons foe I^ot Taking Ac-

8 TioN. — Prior to the expiration of 90 days after the date

9 of publication under subsection (c) , of data and informa-

10 tion with respect to a new chemical substance, or prior to

11 the expiration of such period as extended under subsection

12 (d), the Administrator shall publish a statement of his

13 reasons in the Federal Register, if he decides not to take

14 action under subsection (e) or section 7 with respect to

15 s,uch chemical substance during such period. Manufacture

16 may commence following publication of the Administrator's

17 statement. The Admniistrator's failure to issue such an order

18 under subsection (e) or take action under section 7 is an

19 action subject to judicial review in accordance with section

20 19. Nothing in this subsection prohibits the Administrator

21 from —

22 ( 1 ) promulgating a rule pursuant to section 6 or 4,

23 with respect to such a substance, after such manufacture

24 has commenced;

25 (2) taking action against any chemical substance

X which is found to be an imminent hazard pursuant to

2 section 7 ; or

3 (3) taking any other action authorized by this Act.

4 (g) Exemption. — (1) The Administrator may upon

5 application (made in such form and manner as the Adminis-

6 trator may prescribe) exempt any person from the require-

7 ment of subsection (b) or (h) to submit data for a chemical

8 substance or mixture. If, upon receipt of an appHcation

9 under the precedmg sentence, the Administrator determines

10 that^

11 (A) the chemical substance or mixture with respect

12 to which such application was submitted is equivalent

13 to a chemical substance or mixture for which data has

14 been submitted to the Administrator in accordance with

15 subsection (b) or (h),and

16 (B) submission of data by the applicant with re-

17 (spect to such substance would be duplicative of data

18 which has been submitted to the Administrator in

19 accordance with such subsection,

20 the Administrator shall exempt the applicant from submit-

21 ting such data with respect to such substance. No exemption

22 granted under this subparagraph with respect to the submis-

23 sion of data for a chemical substance or mixt^e may take

24 effect before the beginning of the reimbursement period

25 applicable to such data.

1 (2) If the Administrator, under paragraph (1), ex-

2 empts any person from submitting under subsection (b) or

3 (h) data for a chemical substance or mixi.ture because of

4 the existence of previously submitted data and if such exemp-

5 tion is granted during the reimbursement period for such

6 data, then (unless such person and the persons referred to

7 in subparagraphs (A) and (B) agree on the amount and

8 method of reimbursement) the Administrator shall order the

9 person granted the exemption to provide fair and equitable

10 reimbursement (in an amount determined under rules of the

11 Administrator) —

12, (A) to the person who previously submitted the

13, data on which the exemption was basedj for a portion of

14 the costs incurred by such person in complying' with the

15 requirement under subsection (b) or (h) to submit

16 such data, and

17 (B) to any other person who has been required

18 under this subparagraph to contrib,ute with respect to

19 such costs, for a portion of the amount -such' person

20 was required to contribute.

21 In promulgating rules for the determination of fair and

22 equitable reimbursement to the. persons described -in sub-

23 paragraphs (A) and (B) for costs incurred with respect to

24 a chemical substance or mixture, the Administrator shall,

25 after consulting with the Attorney General and the Federal

1 Trade Commission, consider all relevant factors, including

2 the effect on competition within the chemical industry and

3 the share of the market for such s.ubstance or mixture of the

4 person required to provide reimbursement in relation to the

5 share of such market of the persons to he reimbursed. An

6 order under tliis subparagraph shall be considered final

7 agency action, for purposes of judicial review.

8 (3) For purposes of this paragraph, the reimbursement

9 period for any previously submitted data for a chemical

10 substance or mixture is a period —

11 (A) beginning on the date of the termination of

12 the prohibition, imposed under this section, on the manu-

13 facture or processing of such s.ubstance by the person

14 who submitted such data to the Administrator, and

15 (B) ending—

16 (i) two years after the date referred to in

17 subparagraph (A), or

18 (ii) at the expiration of a period which begins

19 on the date referred to in subparagraph (A) and is

20 equal to the period which the Administrator deter-

21 mines was necessary to develop such data,

22 whichever is later.

23 (h) Significant New Use.— (1) Within 6 months

24 after the date of enactment of this Act, and from time to

25 tune thereafter, the Administrator shall, by rule, establish

S.3149 3

79-313 O -

77 - 7

1 criteria defming a significant new distribution in commerce,

2 use, or disposal of a chemical substance. In establishing such

3 criteria, the Administrator shall take into account —

4 (A) projected volume of production;

5 (B) projected category or categories of uses;

6 (C) projected increase in magnitude and duratiori

7 of human and environmental exposure;

8 (D) route or routes of exposure of human beings

9 or of the environment that are attributable to such

10 signficant new use; and

11 (E) the human health and environmental effects
12, thereof.

13 (2) A chemical substance may not be manufactured or

14 processed for a distribution in conamerce, use, or disposal

15 that is identified by the Administrator, in a rule, as a sig-

16 nificant new distribution in conamerce, use, or disposal, unless,
1^7 at least 90 days prior to such manufacture or processing,

18 the person intending to manufacture or process such substance

19 for such distribution in commerce, use, or disposal submits a

20 notice of his intention to do so and any data required to be

21 developed under section 4 (a) to the Administrator. Any such

22 use of such substance shall be subject to all of the provisions

23 of this section.

24 (i) Special Exemption.— The Administrator may,

^ upon application and by rule, exempt any person from the

2 foregoing requirements of this section —

3 (1) for the purpose of permitting such person to

4 manufacture, process, distribute in commerce, use, or

5 dispose of a new chemical substance to which a rule
Q under section (a) is applicable for test marketing pur-

7 poses or specially limited purposes (A) upon a show-

8 ing by such person that such activity will not cause or

9 contribute to an unreasonable risk of injury to human

10 health or the environment, and (B) under such restric-

11 tions as the Administrator considers appropriate; or

12 (2) to the extent that such person manufactures

13 chemical substances which are intermediate reaction

14 products formed during the manufacture of other chem-

15 ical substances and for which there is no exposure to

16 human beings or the environment.

17 (j) MiXTUEES— The Administrator is authorized to

18 specify any mixture which shall be subject to the provisions

19 of this section.

20 (k) Experimentation. — The requirements of subsec-

21 tions (a), (b), and (h) do not apply to any chemical sub-

22 stance which is manufactured or intended to be manufactured

23 only in small quantities (as defined by the Administrator

24 by rule) solely for scientific experimentation or analysis or

' i for chemical .research or analysis, including such research

2 or analysis for the development of a product, except that

3 the Administrator may, by rule, include such chemical sub-

4 stances upon a finding that the manufacture, processing, dis-
•5 tribution in coimnerce, use, or disposal of such chemical sub-

6 stances may cause or contribute to an unreasonable risk of

7 injury to human health or the environment.

8 EEGULATION OF CHEMICAL SUBSTANCES
0 " AND MIXTURES

-10 Sec. 6. (a) Scope of Regulation — ( 1 ) If the Ad-

11 minis tra tor finds that the manufacture, processing, distribu-

12 tion in commerce, use, or disposal of a chemical substance

13 or mixture presents or is likely to present an unreasonable
-14 'risk of iitjury to health or the environment, the Adminis-

15 tiator shall by rule apply to such substance or mixture one

16 or more of the following requirements as is necessary to

17 adequately protect against such risk:

18 * (A) A requirement prohibiting the manufacturing,

19 processing, or distribution in commerce of such substance
-20 ' or mixture or limiting the amount of such substance or
'21 ' mixture which may be manufactured, processed, or dis-
'22 tributed in conunerce.

23 (B) A requirement—

*24: (I) prohibiting the manufacture, processing

25 or distribution in commerce of such substance or

1 mixture for (i) a particular use or particular u^s

2 or (ii) a particular use or particular uses ini:a

3 concentration in excess of a level specified by the

4 Administrator in the rule imposing the requirement,

5 or

6 (II) limiting the amount of such substance or

7 mixture which may be manufactured, processed,

8 or distributed in commerce for (i) a particular use

9 or particular uses or (ii) a particular use or par-

10 ticular uses in a concentration in excess of a level

11 specified by the Administrator in the rule imposing

12 the requirement. : r

13 (C) A requirement regulating the manner or meth<)d

14 of Use or disposal of such substance or mixture.

15 (I^) A requirement that such substance or mixture

16 or any article containing such substance or ipixture be
1'^ marked with or accompanied by clear and adequate

18 warnings and instructions with respect to its distribution

19 in commerce, use, or disposal. The form and content of

20 such warnings and instructions shall be prescribed by

21 the Administrator.

22 (E) A requirement directing manufacturers or

23 processors of such substance or mixture (i) to give

24 notice of such unreasonable risk of injury to distrib-

1 utors in commerce of such substance or mixture and,

2 to the extent reasonably ascertainable, to other pei*sons

3 in possession of such substance or mixture or exposed

4 to such substance or mixture, (ii) to give public notice

5 of such risk of injury, and (iii) to either replace or re-

6 purchase such substance or mixture whichever the person

7 to which the requirement is dhected elects.

8 t^") -A. requirement that manufacturers and proc-

9 essors of such substance or mixture make and retain

10 records of the processes used to manufacture or process

11 such substance or mixture and monitor or conduct tests

12 which are reasonable and necessary to assure compliance

13 with the requirements of this subsection.

14 A requirement imposed under this subsection may be limited

15 in application to specified geographic areas.

16 (2) Rules limiting the amount of a chemical substance

17 or mixture which may be manufactured, processed, or distrib-

18 uted in commerce, or hmiting the amount of such substance

19 which may be manufactured, processed, or distributed for a

20 particular use, shall, upon the petition of any manufacturer,

21 processor, or distributor in commerce thereof, provide for as-

22 signing production, processing, and distribution quotas, to the

23 extent necessary, with respect to the chemical substance in-

24 volved. The permissible quota for each person who applies to

25 manufacture, process, or import such substance or to engage

1 in its distribution in commerce shall be determined in accord-

2 ance with fair and equitable criteria which the Secretary of

3 Commerce, in consultation with the Administrator and the

4 Attorney General, shall prescribe by rule. Such criteria shall

5 take into account all relevant factors, including (A) effects on

6 competition; (B) the market shares, productive capacity,

7 and product and raw material inventories of the precursors

8 of the chemical substance or mixture of persons applying for

9 quotas; (C) emergency conditions; and (D) effects on

10 technological innovation.

11 (3) (A) Prior to the issuance of a quota under para-

12 graph (2), the persons who apply under such paragraph

13 shall attempt to develop a voluntary agreement limiting the

14 quantities which each such person shall manufacture, process,

15 import, or distribute. The availability of immunity from the

16 antitrust laws with respect to the development of such volun-

17 tary agreement shall be Hmited to the provisions of this

18 subsection.

19 (B) The Secretary of Commerce, with the approval of

20 the Attorney General, after each of them has consulted with

21 the Federal Trade Commission, shall prescribe, by rule,

22 standards and procedures by which persons seeking to manu-

23 facture, process, import, or otherwise distribute a chemical

24 substance or mixture for which limitations on quantity have

25 been prescribed pursuant to paragraph (B) (II) of subsec-

1 tion (a) of this section may develop and carry out such

2 voluntary agreements as are permissible pursuant to this

3 subsection.

4 (C) The standards and procedures prescribed under

5 subparagraph (A) shall include the following requirements:

6 (i) Meetings held to develop or carry out a volun-

7 tary agreement under this subsection shall permit at-
•8 ■ tendance by representatives of Committees of Congress

9 and interested persons, including all persons interested

10 in the chemical substance or mixture involved, and the

11 public; shall be preceded by timely and adequate notice

12 with identification of the agenda of such meeting to the

13 Secretary of Commerce, the Attorney General, the Fed-
11 era! Trade Commission, the Administrator and the pub-

15 lie; and shall be chaired by a regular full-time Federal

16 employee.

,17 (ii) ^ full and complete record, and where prac-

18 ticable a verbatim transcript, shall be kept of any

19 meeting held, and a full and complete record shall be

20 kept of any communication (other than in a meeting)

21 made, between or among participants or potential par-

22 ticipants, to develop, or carry out a voluntary agree-

23 ment under this subsection. Such record or transcript

24 shall be deposited, together with any agreement result-

25 ing therefrom, with the Secretary of Commerce and

26 the Administrator and shall be available to the Attor-

1 ney General and the Federal Trade Commission. Such

2 records or transcripts shall be available for public

3 inspection and copying in accordance with section 552

4 of title 5, United States Code.

5 (I^) (i) The Attorney General and the Federal Trade

6 Commission shall participate from the beginning in the

7 development, and when practicable, in the carrying out of

8 voluntaiy agreements and plans of action authorized under

9 this section. Each may propose any alternative which would

10 void or overcome, to the greatest extent practicable, possible

11 anticompetitive effects while achieving substantially the pur-

12 poses of this subsection. A voluntary agreement under this

13 subsection may not be carried out unless approved by the

14 Attorney General, after consultation with the Federal Trade

15 Commission. Prior to the expiration of the 20-day period

16 prescribed under clause (ii) , the Federal Trade Commission

17 shall transmit to the Attorney General its views as to

18 whether such an agreement or plan of action should be

19 approved, and shall publish such views in the Federal Reg-

20 ister. The Attorney General, in consultation with the Federal

21 Trade Conunission, and the Secretary, shall have the right

22 to review, amend, modify, disapprove, or revoke, on his

23 o^Ti motion or upon the request of the Federal Trade Com-

24 mission or any interested person, any voluntary agreement

25 at any time, and, if revoked, thereby withdraw prospectively

1 any immunity which may be conferred by subparagraphs

2 (F)or(I).

3 (ii) Any voluntary agreement entered into pursuant to

4 this section shall be submitted in writing to the Attorney

5 General and the Federal Trade Commission 20 days before

6 being implemented. Any such agreement shall be available

7 for public inspection and copying, to the extent to which

8 records or transcripts are so available as provided in the

9 last sentence of subparagraph (C) (ii) . Any action taken

10 pursuant to such voluntary agreement or plan of action

11 shall be reported to the Attorney General and the Federal

12 Trade Commission pursuant to such regulations as shall be

13 prescribed under clauses (iii) and (iv) of subparagraph

14 (E).

15 (E) (i) The Attorney General and the Federal Trade

16 Commission shall monitor the development and carrying

17 out of voluntary agreements authorized under this para-

18 graph in order to promote competition and to prevent

19 anticompetitive practices and effects.

20 (ii) In addition to any requirement specified under

21 subparagraph (B) and (C) of this paragraph and in order

22 to carry out the purposes of this section, the Attorney Gen-

23 eral, in consultation with the Federal Trade Conmiission

24 and the Administrator, shall promulgate rules concerning

25 the maintenance of necessary and appropriate records re-

1 lated to the development and carrying out of voluntaiy

2 agreements authorized pursuant to this section.

3 (iii) Persons developing or canying out voluntary

4 agreements authorized pursuant to this section shall main-

5 tain such records as are required by rules promulgated

6 under subparagraph (B) . The Attorney General and the

7 Federal Trade Commission shall have access to and the

8 right to copy such records at reasonable times and upon

9 reasonable notice.

10 (iv) The Attorney General and the Federal Trade Com-

11 mission may each prescribe such rules as may be necessar}^ or

12 appropriate to carry^ out their respective responsibihties under

13 this section. They may both utilize for such purposes and for

14 purposes of enforcement any powers conferred upon the

15 Federal Trade Conamission or the Department of Justice, or

16 both, by the antitrust laws or the Antitrust Civil Process Act;

17 and wherever any such law refers to ''the pui"poses of this

18 Act'' or like terms, the reference shall be understood to in-

19 elude this subsection.

20 (F) (i) There shall be available as a defense to any

21 civil or criminal action brought under the antitrust laws

22 (or any similar State law) in respect to actions taken to

23 develop or carry out a voluntary agreement by persons

24 engaged in the business of manufacturing, processing or dis-

25 tributing such chemical substance or mixture (provided that

100

1 such actions were not taken for the purpose of injuring

2 competition) that —

3 (I) such actions were taken in the course of de-

4 veloping a voluntary agreement pursuant to this para-

5 graph to carry out a voluntary agreement authorized

6 and approved in accordance with this section, and

7 (II) such persons complied with the requirements

8 of this paragraph and the rules promulgated here-

9 under.

10 (ii) Persons interposing the defense provided by this

11 paragraph shall have the burden of proof, except that the

12 burden shall be on the person against whom the defense

13 is asserted with respect to whether the actions were taken

14 for the purpose of injuring competition.

15 (G) No provision of this section shall be construed

16 as granting immunity for, or as hmiting or in any way

17 affecting any remedy or penalty which may result from any

18 legal action or proceeding arising from, any act or practice

19 which occurred prior to the date of enactment of this Act

20 or subsequent to its expiration or repeal.

21 (H) The Attorney General and the Federal Trade

22 Commission shall each submit to the Congress and to the

23 President, at least once each year a report on the impact

24 on competition and on small business of actions authorized

25 by this section.

101

1 (I) In any action in any Federal or State court for

2 breach of contract, there shall be available as a defense

3 that the alleged breach of contract was caused predomi-

4 nantly by action taken to carry out a voluntary agree-

5 ment authorized and approved in accordance with this

6 paragraph.

7 (J) As used in this paragraph, the term ''antitrust

8 laws" hicludes —

9 (i) the Act entitled "An Act to protect trade and

10 commerce against unlawful restraints and monopolies",

11 approved July 2, 1890;

12 (ii) the Act entitled *'An Act to supplement exist-

13 ing laws against unlawful restraints and monopolies,

14 and for other purposes", approved October 15, 1914;

15 (iii) the Federal Trade Commission Act;

10 (iv) sections 73 and 74 of the Act entitled ''An Act

17 to reduce taxation, to provide revenue for the Govem-

18 ment, and for other purposes", approved August 27,

19 1894; and

20 (v) tbe Act of June 19, 1936, chapter 592.

21 (b) Quality Control. — (1) If the Admuaistrator

22 has good cause to beheve that a particular manufacturer or

23 processor is manufacturing or processmg a chemical sub-

24 stance or mixture in a manner which causes the adultera-

25 tion of a chemical substance or mixture —

102
46

1 (A) the Administi-ator may by order require such

2 manufactui'er or processor to submit a description of the

3 relevant quality control procedures followed in the man-

4 ufacturing or processing of such chemical substance or

5 mixture ; and

6 (B) if the Administrator thereafter determines on

7 the record, after opportunity for hearing in accordance

8 with section 554 of title 5, United States Code, that

9 such quality control procedures are inadequate to pre-

10 vent the chemical substance or mixtm*e from causing or

11 contributing to such risk, the Administrator may order

12 the manufacturer or processor to revise such quality

13 control procedures to the extent necessary to remedy

14 such inadequacy.

15 (2) As used in this section, a chemical substance or

16 mixture is adulterated if the manner in which it is manu-

17 factured or processed causes it to contain a particular mo-

18 lecular identity, an uncombined radical, an element, or any

19 combination thereof, which is found by the Administrator

20 to cause or contribute to an unreasonable risk of injury to

21 human health or the environment.

22 (c) Promulgation of Subsection (a) Rules.—

23 (1) In promulgating any rule under subsection (a) with

24 respect to a chemical substance or mixture, the Adminis-

103

1 trator shall consider relevant factors and make findings

2 with respect thereto, including —

3 (A) the risks presented by such substance or mix-

4 ture to health and the magnitude of human exposure to

5 such substance or mixture.

6 (B) the risks presented by such substance or mix-

7 ture to the environment and the magnitude of environ-

8 mental exposure to such substance or mixture,

9 (C) the benefits of such substance or mixture for

10 such use or uses and the availability of other substances

11 or mixtures for such use or uses, and

12 (D) the reasonably ascertainable economic conse-

13 quences of the rule, including consideration of the

14 effect on the national economy, innovation, the environ-

15 ment, and pubhc health.

16 Findings made under this paragi'aph shall be published in

17 the Federal Register.

18 (2) When prescribing a rule under subsection (a) the

19 Administi'ator shall proceed in accordance with section 553

20 of title 5, United States Code (without regard to any

21 reference in such section to sections 556 and 557 of such

22 title) , and shall also (A) publish a notice of proposed rule-

23 making statmg with particularity the reason for the pro-

24 posed rule; (B) allow interested persons to submit written

25 data, views, and arguments, and make all such submissions

104

1 publicly available; (C) provide an opportunity for an in-

2 formal bearing in accordance witb paragraph (3) ; and (D)

3 promulgate, if appropriate, a final rule based on the matter

4 in the rulemaking record.

5 (3) The Administrator shall conduct informal hearings

6 required by paragraph (2) (C) of this subsection in ac-

7 cordance with the following procedure:

8 (A) Subject to subparagraph (B) of this para-

9 graph, an interested person is entitled —

10 (i) to present his position orally or by docu-

11 mentary submissions (or both) , and

12 (ii) if the Admmistrator determines that there

13 are disputed issues of material fact it is necessary

14 to resolve, to present such rebuttal submissions and

15 to conduct (or have conducted under subparagraph

16 (B) (ii) ) such cross-examination of persons as

17 the Administrator determines (I) to be appropriate,

18 and (II) to be required for a full and true dis-

19 closure with respect to such issues.

20 (B) The Administrator may prescribe such rules

21 and make such rulings concerning proceedings in such

22 hearings to avoid unnecessary costs or delay. Such rules

23 or rulings may include (i) imposition of reasonable time

24 limits on each interested person's oral presentations, and

25 (ii) requirements that any cross-examination to which

105

1 a person may be entitled under subparagraph (A) be

2 conducted by the Administrator on behalf of that person

3 in such manner as the Administrator determines (I) to

4 be appropriate, and (II) to be required for a full and

5 true disclosure with respect to disputed issues of material

6 fact.

7 (C) (i) Except as provided in clause (ii) , if a group

8 of persons each of whom under subparagraphs (A) and

9 (B) would be entitled to conduct (or have conducted)

10 cross-examination and who are determined by the Ad-

11 ministrator to have the same or similar interests in the

12 proceeding cannot agree upon a single representative of

13 such interests for purposes of cross-examination, the Ad-

14 ministrator may make rules and rulings (I) limiting the

15 representation of such interest for such purposes, and

16 (II) governing the manner in which such cross-exami-

17 nation shall be limited.

18 • (ii) When any person who is a member of a group

19 with respect to which the Administrator has made a

20 detennination under clause (i) is unable to agree upon

21 group representation with the other members of the

22 group, then such person shall not be denied under the

23 authority of clause (i) the opportunity to conduct (or

24 have conducted) cross-examination as to issues affecting

25 his particular interests if (I) he satisfies tlie Administra-
S.3149 4

79-313 O - 77 - 8

106

1 tor that he has made a reasonable and good faith effort

2 to reach agreement upon group representation with the

3 other members of the group and (II) the Administrator

4 determines that there are substantial and relevant issues

5 which are not adequately presented by the group rep-

6 resentative.

7 (D) A verbatim transcript shall be taken of any

8 oral presentation, and cross-examination, in informal

9 hearings under this subsection. Such transcript shall be

10 available to the public.

11 (E) A substantive amendment to, or repeal of, a

12 rule promulgated under subsection (a) shall be pre-

13 scribed, and subject to judicial review, in the same man-

14 ner as a rule prescribed under such subsection.

15 (4) Any rule promulgated under this section shall be

16 judicially reviewable in accordance with section 19, except

17 that in addition to any basis for holding unlawful or setting

18 aside the rule under subparagraphs (A), (B), (C), or (D)

19 of section 706(2) of title 5, United States Code, the court

20 shall hold unlawful and shall set aside the rule if the court

21 finds that—

22 (A) the Administrator's determination under para-

23 graph (3) that the petitioner is not entitled to conduct

24 cross-examination or make rebuttal submissions, or

25 (B) the Administrator's rule or ruling under para-

107

1 graph (3) limiting the petitioner's cross-examination or

2 rebuttal submissions,

3 has precluded disclosure of disputed material facts which

4 was necessary for fair determination by the Administrator

5 of the rulemaking proceeding taken as a whole.

6 (5) (A) The Admmistrator may, pursuant to rules

7 proscribed by him, provide compensation for reasonable attor-

8 neys fees, expert witness fees, and other costs of participating

9 in a rulemaking proceeding under this section to any person

10 (i) who has, or represents an interest (I) which would not

11 otherwise be adequately represented in such proceeding, and

12 (II) representation of which is necessary for a fair determi-

13 nation of the rulemaking proceeding taken as a whole, or

14 (ii) who is unable effectively to participate in such proceed-

15 ing because such person cannot afford to pay costs of making

16 oral presentations, conducting cross-examination, and making

17 rebuttal submission in such proceeding.

18 (B) The aggregate amount of compensation paid to

19 all persons in any fiscal year under this subsection may

20 not exceed $1,000,000.

21 (d) Effective Date.— ( 1 ) The Administrator shall

22 specify in any rule under subsection (a) the date on which

23 it shall take effect, which date shall be as soon as feasible.

24 (2) Section 553 (b) (B) of title 5, United States Code,

25 shall be applicable to rules issued under subsection (a)

108

1 notwithstanding any requirement of subsection (c) (2) or

2 (3).

3 IMMINENT HAZAEDS

4 Sec. 7. (a) Definition. — An inmiinent hazard shall

5 be considered to exist when the evidence is sufficient to show

6 that the manufacturing, processing, distribution in com-

7 merce, use, or disposal of a chemical substance or mixture

8 presents an unreasonable risk of death, serious illness or

9 serious personal injury, or serious environmental harm prior

10 to the completion of an administrative hearing or other

11 proceeding authorized under any other section of this Act.

12 (b) Actions Authorized. — The Administi*ator may

13 file an action in a United States district court —

M ( 1 ) against an imminently hazardous chemical sub-

15 stance or mixture for seizure of such substance or mixture,

16 (2) against any person who manufactures, processes,

17 distributes in commerce, uses, or disposes of such sub-

18 stance or mixture, or

19 (3) against both (A) such substance or mixture

20 and (B) such person.

21 An action under this subsection may be filed notwith-

22 standing the existence of a rule under section 4 (a) or 6 (a)

23 or an order under section 5(e) and notwithstanding the

24 pendency of any administrative or judicial proceeding under

25 any provision of this Act.

109

1 (c) Jurisdiction of Court — (1) The United

2 States district court in which an action under subsection (b)

3 is brought shall have jurisdiction to grant such temporary

4 or permanent relief as may be necessary to protect against

5 such unreasonable risk of death, serious illness or serious

6 personal injury, or serious environmental harm presented

7 by the chemical substance or mixture involved in such action.

8 (2) In the case of an action under subsection (b)

9 brought against a person who manufactures, processes, dis-

10 tributes in commerce, uses, or disposes of a chemical substance

11 or mixture, the relief authorized by paragraph ( 1 ) may in-

12 elude the issuance of a mandatory order requiring (A) in the

13 case of purchasers of such substance or mixture known to

14 the defendant, notification to such purchasers of the risk as-

15 sociated with it ; (B) public notice of such risk ; (C) recall;

16 and (D) the replacement or repurchase of such substance

17 or mixture.

18 (3) In the case of an action under subsection (b)

19 against a chemical substance or mixture, such substance or

20 mixture may be proceeded against by process of libel for

21 its seizure and condemnation. Proceedings in such an action

22 shall conform as nearly as possible to proceedings in rem

23 in admiralty.

24 (d) Venue and Consolidation.— ( 1 ) (A) An ac-

25 tion under subsection (b) against a person who manufac-

110

1 tures, processes, distributes in commerce, uses, or disposes of a

2 chemical substance or mixture may be brought in the United

3 States District Court for the District of Cohimbia or for any

4 judicial district in which any of the defendants is found,

5 resides, or ti'ansacts business; and process in such an action

6 may be served on a defendant in any other district in which

7 such defendant resides or may be found. An action under

8 subsection (b) against a chemical substance or mixture

9 may be brought in any United States district court

10 within the jurisdiction of which the substance or mixture

11 is found.

12 (B) In determining the judicial district in whigh an

13 action may be brought under subsection (b) in instances in

14 which such action may be brought in more than one judicial

15 district, the Administrator shall take into account the con-

16 venience of the parties.

17 (C) Subpoenas requiring attendance of witnesses in

18 an action brought under subsection (b) may run into any

19 judicial district.

20 (2) Whenever proceedings under subsection (b) in-

21 volving the same type of chemical substances or mixtures

22 are pending in courts in two or more judicial districts,

23 they shall be consolidated for trial by order of any

24 such court upon application reasonably made by any party

25 in interest, upon notice to all parties in interest.

Ill

1 (e) Action Under Section 6 — Where appropriate,

2 concurrently with the filing of an action under subsection (b)

3 or as soon thereafter as may be practicable, the Administra-

4 tor shall -initiate a proceeding for the promulgation of a rule

5 under section 6 (a) .

6 (f) Representation— Notwithstanding any other

7 provision of law, in any action under subsection (b) , the

8 Administrator may direct attorneys of the Environmental

9 Protection Agency to appear and represent the Administra-
10 tor in such an action.

11 REPORTING AND RETENTION OF INFORMATION

12 Sec. 8. (a) Reports.— (1) The Administrator shall

13 promulgate rules under which —

14 (A) each person who manufactures or processes

15 or proposes to manufacture or process a chemical sub-

16 stance shall maintain such records, and shall submit to

17 the Administrator such reports, as the Administrator may

18 reasonably require, and

19 (B) each person who manufactures or processes or

20 proposes to manufacture or process —

21 (i) ^ mixture, or

22 (ii) a chemical substance in small quantities

23 (as defined by the Administrator by rule) solely for

24 scientific experimentation or analysis or for chemical

112

1 research or analysis, including sucli research or

2 analysis for the development of a product,

3 shall maintain records and submit to the Administrator

4 reports but only to the extent the Administrator deter-

5 mines the maintenance of records or submission of re-
5 ports, or both, is necessary for the effective enforcement

7 of the Act.

8 For purposes of the compilation of the list of chemical

9 substances required under subsection (b) , the Administrator

10 shall promulgate rules pursuant to this subsection not later

11 than 180 days after the date of the enactment of this Act.

12 (2) The Administi'ator may require under paragraph

13 (1) reporting with respect to the following:

14 (A) The common name, trade name, the chemical

15 identity, and the molecular structure and identity of each

16 chemical substance or mixture for which such a report

17 is required, insofar as known to the person making the

18 report or insofar as reasonably ascertainable.

19 (B) The categories or proposed categories of use

20 of each such substance or mixture, insofar as known to

21 the person making the report or insofar as reasonably

22 ascertainable.

23 (C) Reasonable estimates of the amount of each

24 substance and mixture to be manufactured or processed

25 and, insofar as known to the person making the report

113
57

1 or insofar as reasonably ascertainable, a reasonable esti-

2 mate of the amount of each such substance and mixture

3 to be manufactured or processed for each of its categories

4 or proposed categories of use.

5 (I)) ^ description of the byproducts resulting from
Q the manufacture, processing, use, or disposal of each such
7 substance or mixture, insofar as known to die person
3 making the report or insofar as reasonably ascertainable.
9 (E) All existuig data concerning the environmental

IQ and health effects of such substance or mixture, insofar

11 as known to the person making the report or are reasou-

12 ably ascertainable.

13 (F) Estimates of the number of persons who will

14 be exposed to such substance or mixture in their places

15 of employment and the duration of such exposure, insofar

16 as known to the person making the report or are reason-

17 ably ascertainable.

18 (b) Inventory.— The Administrator shall compile,

19 keep current, and publish a Hst of each chemical substance or

20 mixture which any person reports under subsection (a) or

21 under section 5 (a) is manufactured or processed in the United

22 States. The Administrator shall first publish such a list not

23 later than 270 days after the date of the enactment of this

24 Act. The Administrator shall not include in such list any

114

1 chemical substance which is manufactured or processed only

2. in small quantities (as defined by the Administrator by rule)

3. solely for scientific experimentation or analysis or for chemi-

4 cal research or analysis, including such research or analysis

5 for the development of a product.

6 (c) Kecoeds.— Any person who manufactures, proc-

7 esses, or distributes in commerce or intends to manufacture,

8 process, or distribute in commerce any chemical substance

9 or mixture shall maintain records of adverse reactions to

10 health or the environment alleged to have been caused by

11 the substance or mixtm*e. Records of such adverse reactions

12 to the health of employees shall be retained for 36^ years

13 from the date such reactions were fii-st reported to or known

14 by the person maintaining suoh records; and an}^ other

15 record of such adverse reactions shall be retained for 5 years

16 from the date the information contained in the records was

17 first reported to or known by the person maintaining the

18 records. Records .under this subsection shall include records

19 of consumer allegations of personal injuiy or harm to health,

20 reports of occupational disease or injury, and reports or

21 complaints of injuiy to the environment subniitted to the

22 manufacturer, processor, or distributor in commerce from

23 any source. Upon request of an officer or employee duly

24 designated by the Administrator, each person who is rc-

25 quired to maintain records under this subsection shall permit

115
59

1 the inspection of such records and shall submit copies of

2 such records.

3 (d) Health and Safety Studies— The Admlnis-

4 trator shall promulgate r.ules under which the Administrator

5 requires any person who manufa<itures, processes, or dis-

6 tributes in commerce or who proposes to manufacture, proc-

7 ess, or distribute in commerce any chemical substance or

8 mixture to submit to the Administrator —

9 ' (1) l^sts of health and safety studies conducted or

10 initiated by or for such person with respect to such

11 substance or mixture at any time or known to such

12 person or are reasonably ascertainable, except that the

13 Administrator may exclude certain types or categories

14 of studies from the requirements of this subsection if he

15 finds that submission of hsts of such studies are unneces-

16 sary to carry out the purposes of this Act ; and

17 (2) the Administrator may require the submission

18 of any study contamed on a list submitted pursuant to

19 paragraph (1) or otherwise known by such person.

20 (e) Notice to Administeator of Unreasonable

21 Risks. — Any person who manufactures, processes, or dis-

22 tributes in commerce a chemical substance or mixture, and

23 any liability insurer of such person, who obtains information

24 which supports the conclusion that such substance or mixture

25 causes or contributes to an unreasonable risk of mjury to

116

1 health or the environment shall immediately inform the Ad-

2 ministrator of such risk unless such person has reason to

3 believe that the Administrator has been adequately informed

4 of such risk.

5 EELATIONSHIP TO OTHER FEDERAL LAWS

6 Sec. 9. (a) Laws Not Administered by the Ad-

7 MINISTRATOR. — ( 1 ) If the Administrator has reason to be-

8 lieve that the manufacture, processing, distribution in com-

9 merce, use, or disposal of a chemical substance or mixture

10 causes or contributes to, or is likely to cause or contribute to

11 an unreasonable risk of injury to health or the environment,

12 and determines, in his discretion, that such risk may be

13 prevented or reduced to a sufficient extent by action taken

14 under a Federal law not administered by the Administra-

15 tor, the Administrator shall request the agency which ad-

16 ministers such law (A) to issue an order declaring whether

17 or not the manufacture, processing, distribution in commerce,

18 use, or disposal of such substance or mixture causes or con-

19 tributes to or is likely to cause or contribute to such a risk,

20 and (B) if the agency issues an order declaring that such

21 manufacture, processing, distribution in commerce, use, or

22 disposal respecting such substance or mixture causes or con-

23 tributes to or is likely to cause or contribute to such a risk,

24 to determine if such risk may be prevented or reduced to a

25 sufficient extent by action taken under such law. Any such

117

1 request shall be published in the Federal Register and shall

2 be accompanied by a detailed statement of the information

3 on which it is based. The agency receiving the request shall

4 consider carefully all data submitted by the Administrator

5 and other information available to it and shall issue an appro-

6 priate order upon request, and shall make any resulting de-

7 termination within such reasonable time as the Adminis-

8 trator specifies in the request, but such time specified may

9 not be less than 90 diays from the date the request was

10 made. The report of an agency in response to a request made

11 under this paragraph shall be accompanied by a detailed

12 statement of the findings and conclusions of the agency re-

13 specting the order and determination requested to be made,
li (2) If the Administi'ator makes a request under para-
15 graph (1) with respect to a chemical substance or mixture
1(^ and the agency to which such request was made either —

17 (A) issues an order declaring that there is no

18 unreasonable risk of injury to health or the environment

19 associated with such substance or mixture, or

20 (B) initiates, within 90 days of the publication

21 in the Federal Register of the report of the agency

22 under paragraph ( 1 ) in response to such request, action

23 under the law (or laws) administered by such agency

24 to protect against such a risk,

25 the Adnunistrator may not take any action under section 6

118
62

1 or 7 with respect to the risk associated with such substance

2 or mixture. Nothing contained herein shall prevent the

3 Administrator from (A) making any subsequent request

4 under paragraph (1) with respect to such risks or (B) to

5 take subsequent action under this Act with respect to such

6 risks if the requirements of this subsection are satisfied.

7 (3) If the Administrator has initiated action under sec-

8 tion 6 or 7 with respect to a risk of injury associated with a

9 chemical substance or mixture which was the subject of a

10 request made to an agency under paragraph ( 1 ) , such

11 agency shall before taking action under the law (or laws)

12 administered by it to protect against such risk consult with

13 the Administrator for the purpose of avoiding duplication of

14 Federal action against such risk.

15 (b) Laws Administeeed BY THE Admixisteator. —

16 The Administrator shall coordinate actions taken under this
IT Act with actions taken under other Federal laws administered

18 in whole or in part by the Administrator. The Administrator

19 shall use the authorities contained in such other Federal laws

20 to protect against any risk to health or the environment asso-

21 ciated with a chemical substance or mixture unless the Ad-

22 ministrator, in his discretion, determines that such risk may

23 be more appropriately protected against under this Act. This

24 subsection shall not be construed to relieve the Administrator

119

1 of any requirement imposed on the Administrator by sucli

2 other Federal laws. Nothing contained in this subsection shall

3 (1) affect any final action taken under such other Federal

4 law, or (2) in any way affect the extent to which hum;an

5 health or the environment is to be protected under such other

6 Federal law.

7 (c) Occupational Safety and Health. — In exer-

8 cising any authority under this Act, the Administrator sh^ll

9 not, for purposes of section 4(b) (1) of the Occupational

10 Safety and Health Act of 1970, be deemed to he exercising

11 statutory authority to prescribe or enforce standards or regu-

12 lations affecting occupational safety and health.

13 (d) Coordination. — In administering this Act, the

14 Administrator shall consult and coordinate with the Secre-

15 tary of Health, Education, and Welfare and the heads of

16 any other appropriate Federal executive . department or

17 agency, any relevant independent regulatory agency, and

18 any other appropriate instrumentality of the Federal Gov-

19 emment for the purpose of achieving the maximum enforce-

20 ment of this Act while imposing the least burdens of dupli-

21 cative requirements on those subject to the Act and for other

22 purposes. The Administrator shall report annually to the

23 Congress on actions taken to coordinate with such other Fed-

24 eral departments, agencies, or instrumentalites, and on

120

1 actions taken to coordinate the authority under this Act with

2 the authority granted under other Acts referred to in sub-

3 section (b) .

4 (e) Exception. — Nothing contained in this section shall

5 limit any requirement of section 4, 5 (other than section

6 5 (e) (2) ) , or 8, or rules promulgated thereunder.

7 RESEARCH, COLLECTION, DISSEMINATION, AND

8 UTILIZATION OF DATA

9 Sec 10. (a) Authority.— The Administrator shall, in

10 consultation and cooperation with the Secretary of Health,

11 Education, and Welfare and with other heads of appropriate

12 agencies, conduct such research and monitoring as h neces-

13 sary to carry out the purposes of this Act.

14 (b) Data Systems.— ( 1 ) The Administrator shall

15 establish, administer, and be responsible for the continuing

16 activities of an interagency committee which will (A) de-

17 sign, establish, and coordinate an efficient and effective sys-

18 tern, within the Environmental Protection Agency, for the

19 collection, dissemination to other Federal agencies, and use

20 of data submitted to the Administrator under this Act and

21 (B) coordinate the regulation of chemical substances among

22 Federal agencies.

23 (2) (A) The Administrator shall, in consultation witii

24 the Secretary of Health, Education, and Welfare and other

25 heads of appropriate agencies, design, establish, and coordi-

121

1 nate an efficient and effective system for the retrieval of toxi-

2 cological and other scientific data which could be useful to the

3 Administrator in carrying out the purposes of this Act. Sys-

4 tematized retrieval shall be developed for use by all Federal

5 and other agencies with responsibilities in the area of regula-

6 tion or study of chemical substances and mixtures and their

7 effect on health or the environment.

8 (c) Grants and Contkacts.— The Administrator, in

9 consultation with the Secretary of Health, Education, and

10 Welfare, is authorized to make grants and enter into con-

11 tracts in order to carry out his responsibilities under this sec-

12 tion. Contracts may be entered into under this section without

13 regard to sections 3648 and 3709 of the Revised Statutes
11 (31U.S:C.529,41 U.S.C.5).

15 INSPECTIONS AND SUBPOENAS

16 Sec. 11. (a) Inspections.— ( 1 ) For purposes of ad-

17 ministermg this Act (including any rule or order promul-

18 gated under this Act) the Administrator, or any representa-

19 tive of the Admmistrator duly designated by the Administra-

20 tor, may inspect any establishment, facility, or other premises

21 in which chemical substances or mixtures are manufactured,

22 processed, stored, or held before or after distribution in com-

23 merce and any conveyance being used to transport chemical

24 substances or mixtures in connection with distribution in com-

25 merce. Such an inspection may only be made upon presenting

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1 appropriate credentials and a written notice to the owner,

2 operator, or agent in charge of the premises or conveyance

3 to he inspected. A separate notice shall he given for each

4 such inspection, but a notice shall not be required for each

5 entry made during the period covered by the inspection.

6 Each such inspection shall be commenced and completed

7 with reasonable promptness and shall be conducted at rea-

8 sonable times, within reasonable limits, and in a reasonable

9 manner.

IQ (2) An mspection under paragraph (1) shall extend to

11 all things within the premises or conveyance inspected (in-

12 eluding records, files, papers, processes, controls, and facili-

13 ties) bearing on whether the requirements of this Act appli-

14 cable to the chemical substances or mixtures within such

15 premises or conveyance have been comphed with.

16 (b ) Subpoenas. — ^In carrying out his or her duties under

17 the provisions of this Act, the Administrator may by subpoena

18 require the attendance and testimony of witnesses and the

19 production of reports, papers, documents, answers to ques-

20 tions, or other infonnation that the Administrator deems

21 advisable. Witnesses shall be paid the same fees and mileage

22 that are paid witnesses in the courts of the United States. In

23 the event of contumacy, failure, or refusal of any person to

24 obey any such order, any district court of the United States

25 in which venue is proper shall have jurisdiction to order any

123

,67

1 such person to comply therewith. The faihire to ohey such

2 order of the Court is punishable by the Court as a contempt

3 thereof.

4 EXPORT

5 Sec. 12. (a) General.— (1) Except as provided in

6 paragraph (2) and subsection (b), this Act (other than

7 section 8) shall not apply to any chemical substance or

8 mixture, if —

9 (^M ^^^^ shown that such substance or mixture

10 is being manufactured, processed, sold, or held for sale,

11 for export from the United States, unless such substance

12 or mixture is, in fact, manufactured, processed, or dis-

13 tiibuted in commerce, for use in the United States, and

14 (B) such substance or- mixture, when distributed

15 in commerce, or any container in which it is enclosed

16 when so distributed, bears a stamp or label stating

17 that such substance or mixture, is intended for export.

18 (2) Paragraph (1) shall not apply to any chemical

19 substance or mixture if the Administrator finds that the

20 substance or mixture will cause or contribute to an unreason-

21 able risk of injury to the health of persons within the United

22 States or to the environment of the United States or may

23 cause or contribute to such risk. The Administrator may

24 require, under section 4, testing of a chemical substance or

25 mixture exempted from this Act by paragraph (1) to

124
68

1 determnie whether or not such substance or mixture causes

2 or contributes to an unreasonable risk to health within the

3 United States or to the environment of the United States.

4 (b) Notice. — (1) If any person exports or intends

5 to export to a foreign country a chemical substance or mix-

6 ture for which the submission of data is required under sec-

7 tion 4 or 5, such person shall notify the Administrator of

8 such exportation or intent to export and the Administrator

9 shall furnish to the government of such country notice of the

10 availabihty of the data (subject to section 14) submitted to

11 the Administrator under section 4 or 5 for such substance or

12 mixture. ^

13 (2) If any person exports or intends to export to a for-

14 eign country a chemical substance or mixture for which a rule

15 has been proposed or promulgated under section 5 or 6, or

16 with respect to which an action is pending, or rehef has been

17 granted, under section 7, such person shall notify the Ad-

18 ministrator of such exportation or intent to export and the

19 Administrator shall furnish to the government of such coun-

20 try notice of such rule, action, or relief.

21 ENTEY INTO CUSTOMS TERRITORY OF THE UNITED STATES

22 Sec. 13. (a) General.— (1) The Secretary of the

23 Treasury shall refuse entry into the customs territory of the

24 United States (as defined in general headnote 2 to the Tariff

125
69

3 Schedules of the United States) of any chemical substance or

2 mixture offered for entry if —

3 (^) it fails to conform with any requirement of this

4 Act or any rule in effect thereunder, or

5 (B) it is otherwise prohibited pursuant to this Act
Q from bemg distributed in commerce.

7 (2) If a chemical substance or mixture is refused

8 entry under paragraph ( 1 ) , the Secretary of the

9 Treasury shall notify the consignee of such entry refusal,

10 shall not release it to the consignee, and shall cause its

11 disposal or storage (under such regulations as the Secre-

12 taiy of the Treasury may prescribe) if it has not been ex-

13 ported by the consignee within 90 days from the date

14 of receipt of notice of such refusal, except that the Secre-

15 tary of the Treasuiy may, pending a review by the Admin-

16 istrator of the entry refusal, release to the consignee such

17 substance or mixture on execution of bond for the amount

18 of the full invoice of such substance or mixture (as such

19 value is set forth in the customs entry), together with

20 the duty thereon. On failure to return such substance or

21 mixture for any cause to the custody of the Secretary

22 of the Treasury when demanded, such consignee shall be

23 liable to the United States for liquidated damages equal

24 to the full amount of such bond. All charges for storage,

126

1 cartage, and labor on such substances or mixtures which

2 are refused entry or release under this section shall be

3 paid by the owner or consignee, and in default of such

4 payment shall constitute a lien against any future entry

5 made ])y such owner or consignee. Nothing contained

6 herein shall limit any other remedy to which the United

7 States is entitled.

8 (b) KuLES. — The Secretary of the Treasury, after

9 consultation with the Administrator, shall issue rules for

10 the enforcement of subsection (a) of this section.

11 DISCLOSURE OF DATA

12 Sec. 14. An}^ information reported to, or otherwise

13 obtained by, the Administrator or his representative, under

14 this Act, shall be subject to section 552 of title 5, United

15 States Code ; except that such infoi-mation shall be disclosed —

16 (1) upon request, to officers or employees of the

17 United States, in connection with their official duties

18 (A) under laws protecting human health or the cn-

19 vironment or (B) for specific law enforcement purposes ;
^0 (2) to contractors with the United States and

21 employees of such contractors if in the opinion of the

22 Administrator sucli disclosure is necessary for the satis-

23 factory performance by the contractor of a contract

24 with the United States entered into on or after the date

127

1 of enactment of this Act for the perfonnance of work

2 in connection with this Act and under such conditions

3 as the Administrator may specify ;

4 (3) whenever the Administrator determines it nec-

5 essary to protect human heahli or the environment; or

6 (4) to any duly authorized committee of the Con-

7 gress upon written request of such committee or any

8 chairman thereof.

9 PROHIBITED ACTS

10 Sec. 15. It shall he unlawful for any person to-
ll (1) fail or refuse to comply with- (A) an}- rule or

12 order promulgated under section 4, (B) any requirement

13 prescrihed hy section 5, or (C) any rule or order pro-

14 mulgated under section 5 or 6;

15 (2) use or dispose of a chemical suhstance or mix-

16 ture which such person knew or had reason to know was

17 manufactured, processed, or distrihuted in commerce in

18 violation of section 5 or a rule or order under section 6;

19 (3) fail or refuse to (A) estahlish or maintain rec-

20 ords, (B) suhmit reports, notices, or other informa-

21 lion, or (C) permit access to or copying of records, as

22 required by this Act or a rule thereunder; or

23 (4) fail or refuse to permit entry or inspection as

24 required by section 11.

128

2 PENALTIES

2 Sec. 16. (a) Civil. — (1) Any person who violates

3 a provision of section 15 of this Act shall be liable to the

4 United States for a civil penalty in an amount not to exceed

5 $25,000 for each such violation. Each day such a violation
Q continues shall for purposes of this subsection constitute a
rj separate violation of section 15.

g (2) (A) A civil penalty for a violation of section 15

9 shall be assessed by the Administrator by an order made on

"I^Q the record after opportunity (provided in accordance with

II this subparagraph) for a hearing in accordance with sec-

-^2 tion 554 of title 5, United States Code. Before issuing such

;i^3 an order, the Administrator shall give written notice to the

24 person to be assessed a civil penalty under such order of the

25 Administrator's proposal to issue such order and providing

26 such person an opportunity to request, within 15 days

27 of the date the notice is received by such person, such a

28 hearing on the order.

29 (B) In determining the amount of a civil penalty, the
20 Administrator shall take into account the nature, circum-
22 stances, exten', and gravity of the violation or violations

22 and, with respect to the violator, ability to pay, effect on

23 ability to continue to do business, any history of prior such

24 violation.^, the degree of culpability, and such other matters

25 as justice may require.

129

1 (C) The Administrator may compromise, modify, or

2 remit, with or without conditions, any civil penalty which

3 may be imposed under this subsection. The amount of such

4 penalty, when finally determined, or the amount agreed

5 upon in compromise, may be deducted from any sums owed
Q by the United States to the person charged.

7 (3) Any pei^on who requested in accordance with

8 paragraph (2) (A) a hearing respecting the assesment of a

9 civil penalty and who is aggrieved by an order assessing a

10 civil penalty may file a petition for judicial review of such

11 order with the United States Court of Appeals for the Dis-

12 trict of Columbia Circuit or for any other circuit in which

13 such person resides or transacts business. Such a petition

14 may only be filed within the 30-day period beginning on

15 the date the order making such assessment was issued.

16 (4) If any person fails to pay an assessment of a civil

17 penalty after it has become a final and unappealable order,

18 or after a court in an action brought under paragraph (3)

19 has entered final judgment in favor of the Administrator,

20 the Attorney General shall recover the amount assessed

21 (plus interest at currently prevailing rates from such date)

22 in any appropriate United States district court. In such

23 action, the validity, amount, and ap})ropriateness of such

24 penalty shall not be subject to review.

25 (b) Ceiminal. — (1) Any person who knowingly or

130

1 willfully violates any provision of section 15 shall, in addi-

2 tion to or in lieu of a civil penalty which may be imposed

3 under subsection (a) of this section for suoh violation, be

4 subject upon conviction, to a fine of not more than $25,000

5 for each day of violation, or to imprisonment for not more

6 than 1 year, or both.

7 (2) For purposes of paragraph (1), the term "know-

8 ingly'* means having actual knowledge.

9 SPECIFIC ENFORCEMENT AND SEIZURE

10 Sec. 17. (a) Specific Enforcement.— ( 1 ) Upon

11 application of the Administrator or the Attorney General

12 the United States district courts shall have jurisdietion over

13 civil actions to —

14 (A) restrain any violation of section 15,

15 (B) restrain any person from manufacturing or

16 processing a chemical substance before the expiration

17 of the period during which such manufacturing or proc-

18 essing is prohibited under section 5,

19 (C) restrain any person from taking any action

20 prohibited by a requirement prescribed under section

21 5 or 6 or rules or orders issued thereunder or,

22 (U) direct any manufacturer or processor of a

23 chemical substance or mixture not in compliance with

24 any order issued under section 5 (e) or any rule issued

25 under section 4 or 6, (i) to give notice of such fnct to

131

1 distributors in commerce of such substance or mixture

2 and, to the extent reasonably ascertainable, to other

3 persons in possession of such substance or mixture or

4 exposed to such substance or mixture, (ii) to give public

5 notice of such risk of injury, and (iii) to either replace

6 or repurchase such substance or mixture whichever

7 the person to which the requirement is directed elects.

8 (E) compel the taking of any action required by

9 or under this Act.

10 (^) ^ ^'i^'il i^^'tion described in paragraph (1) may be

11 brought —

12 (A) in the case of a civil action described in sub-

13 paragraph (A) of such paragraph, in the United States

14 district court for the judicial district wherein any act,

15 omission, or transaction constituting a violation of sec-

16 tion 15 occurred or wherein the defendant is found or
1.7 transacts business, or

18 (B) in the case of any other civil action described

19 in such paragi'aph, in the United States district court

20 for the judicial district wherein the defendant is found

21 or transacts business.

22 In any such civil action process may be served on a defend-

23 ant in any judicial district in which a defendant resides or

24 may be found. Sul)poenas requiring attendance of witnesses

25 in any such action may run into any judicial district.

132

1 (b) Seizure. — Any chemical substance or mixture

2 which was manufactured, processed, or distributed in com-

3 merce in violation of this Act or any rule or order promul-

4 gated under this Act shall be hable to be proceeded against,

5 by process of libel for the seizure and condemnation of such
Q substance or mixture in any United States district court

7 within the jurisdiction of which such substance or mixture

8 is found. Such proceedings shall conform as nearly as pos-

9 sible to proceedings in rem in admiralty.

10 PEEEMPTION

11 Sec. 18. (a) Effect on State Law.— (1) Except

12 as provided in paragraph (2), nothmg in this hct shall

13 affect the authority of any State or political subdivision of a

14 State to establish or continue in effect regulation of any

15 chemical substance or mixture containing a chemical sub-

16 stance or mixture.

17 (2) Except as provided in subsection (b) —

18 (^) if the Administrator requires by rule promul-

19 gated under section 4 the testing of a chemical sub-

20 stance or mixture, no State or political subdivision may,

21 after the effective date of such mle, require the testing

22 of such substance or mixture for purposes similar to

23 those for which testing is required under such rule;

24 and

133

2 (B) if the Administrator prescribes a requirement

2 under section 5 or 6 of this Act which is appUcahle to

2 a chemical substance or mixture and which is designed

4 to protect against a risk to heaUh or the environment

5 associated with such substance or mixture no State or
Q poHtical subdivision of a State may, after the effective
rj date of such requirement, estabhsh or continue in effect
g a requirement appHcable to such substance or mixture
9 and designed to protect against such risk unless such

requirement is identical to the requirement prescribed

H by the Administrator or unless such State or political

^2 subdivision requirement prohibits the use or distribution

of such substance or mixture within the territorial juris-

14 diction of the State or political subdivision.

15 (b) Exemption— Upon apphcation of a State or

16 political subdivision of a State, the Administi'ator may by

17 rule exempt such State or subdivision from subsection (a)

18 (2), undet such conditions as may be prescribed in such

19 rule, if—

20 (1) compliance with the requirement would not

21 cause the substance or mixture to be in violation of the

22 applicable requirement under this Act described in sub-

23 section (a) (2) , and

24 (2) the State or political subdivision requirement

134

1 (A) provides a significantly higher degree of protection

2 from such risk than tlie reqiih'ement under this Act de-

3 scribed in suhsection (a) (2), and (B) does not, through

4 difficulties in marketing, distribution, or other factors,

5 unduly burden interstate commerce.

Q JUDICIAL EE\1EW

7 Sec. 19. (a) General.— Not later than GO days

8 following the promulgation of any rule under this Act or an

9 order under section 5 (e), any interested person may file a

10 petition for judicial review of such rule or order with the

11 United States Court of Appeals for the District of Columbia

12 Circuit, or for the circuit in which such person resides or in

13 which such person's principal place of business is located.
1,1 Copies of the petition shall be forthwith transmitted by the
15 clerk of such court to the Administi'ator and to the Attorney
1(5 General. The Administrator shall transmit to the Attorney

17 General, who shall file in the court, the record of the pro-

18 ceedings on which the A(hninistrator based such rule or

19 order as provided in section 2112 of title 28, United

20 States Code. For purposes of this section, the term "record"

21 means such rule or order, any transcript required of any

22 oral presentation; any written submission of interested par-

23 ties; and any other inforaiation which the Administrator
21 considers to be relevant to such rule or order and with respect
25 to which the Administrator, on or before the date of the

135

1 promulgation of such rule or order, published a notice in

2 the Federal Eegister identifying such information.

3 (b) Additional Data. — ^If the petitioner applies to

4 the oo^rt for leave to adduce additional data, views, or

5 arguments, and shows to the satisfaction of the court that

6 such additional data, views, or arguments are material and

7 that there are reasonable gromid^ for tlie petitioner's failure

8 to adduce such data, views, or argmnents in the proceeding

9 before the Administrator, the coui't may order the Adminis-

10 trator to provide additional opportunii}' for oral presentation

11 of data, views, or arguments and for written submissions.

12 The Administrator ma}^ modify findings or determinations

13 upon which the rule or order, subject to review by such court

14 was based, or make new findings or determinations by reason

15 of the additional data, yiews, or argimients so taken and shall

16 file s,uch modified or new findings or determinations, and the

17 Administrator's rccoimiicndation, if any, for the modifica-

18 tion or settmg aside of such rule or order, with the return of

19 such additional data, views, or arguments.

20 (c) AuTHOKiTY AND Review Standard.— ( 1 ) Upon

21 the fiUng of a petition under subsection (a) , the court shall

22 have jurisdiciton (A) to review the rule or order involved,

23 in accordance with chapter 7 of title 5, United States Code,

24 and (B) to grant appropriate relief, including interim reHef,

136

2 as provided in such chapter, except that any rule promulgated

2 by the Administrator under section 3(b), 5, or 6 of this

3 Act and reviewed under this section shall be aifinned, unless

4 the rule is not supported by substantial evidence on the record
g taken as a whole.

Q (2) The judgment of the court affirming or setting aside,

fj in whole or in part, any rale or order reviewed in accordance

g with this section shall be final, subject to review by the

9 Supreme Court of the United States upon certiorari or certi-
fication, as provided in section 1254 of title 28, the United

II States Code.

22 (3) The judgment of the court in an action brought

23 pursuant to subsection (a) may include an award of costs

14 of suit and reasonable fees for attorneys and expert witnesses

15 if the court determines that such an award is appropriate.
IQ The Supreme Court of the United States in its decision on a

17 review of a judgment in such an action may provide for the

18 award of costs of suit and reasonable fees for attorneys if the

19 court determines that such an award is appropriate.

20 (d) Other Remedies. — The remedies provided in this

21 section shall be in addition to and not in lieu of any other

22 remedies provided by law.

23 citizen's civil action

24 Sec. 20. (a) In General.— Except as provided in

25 subsection (b) , any person may commence a civil action —

137

1 (1) against any person (includmg (A) the United

2 States, and (B) any other governmental instrumentality

3 or agency to the extent permitted by the eleventh amend-

4 ment to the Constitution) who is alleged to be in viola-

5 tion of this Act or any rule or order f)rescribed under

6 section 4, 5, or 6 (a) to restrain such violation, or

7 (2) against the Administrator to compel the A(i-

8 ministrator to perform any act or duty under this Act

9 which is not discretionary.

10 Any civil action under paragraph (1) shall be brought in the

11 district court of the United States for the district in which

12 the alleged violation occurred or in which the defendant

13 resides or in which the defendant's principal place of busi-

14 ness is located. Any action brought under paragraph (2)

15 shall be brought in the district court for the District of Colum-

16 bia, or the United States district court for the judicial district

17 in which the plaintiff is domiciled. The district courts shall

18 have jurisdiction over suits brought under this section, with-

19 out regard to the amount in controversy or the citizenship of

20 the parties. In any civil action under this subsection, process

21 may be served on a defendant in any judicial district in which

22 the defendant resides or may be found and subpoenas for

23 witnesses may run into any judicial district.

24 (b) Limitation.— No civil action may be com-

25 menced —

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138

1 (1) under subsection (a) (1) to restrain a viola-

2 tion of this Aet or rule or order under this Act —

3 (A) before the expiration of sixty days after

4 the plaintiff has given notice of such violation (i)
^ to the Administrator, and (ii) to the person who
g is alleged to have committed such violation, or

-tjf (B) if Administrator (or Attorney General

g. on hig behalf) has commenced and is diligently

g prosecuting a civil action in a court of the United

2Q States to require comphance with this Act or such

j2 rule, but if such action is commenced after the giv-

j2 iug of notice, any person giving such notice may

j3 intervene as a matter of right in such action ; or

14 (2) under subsection (a) (2) before the expira-

15 tion of 60 days after the plaintiff has given notice

16 to the Administrator of the alleged failure of the Ad-

17 ministrator to perform an act or duty which is the basis

18 for such action or, in the case of an action under such

19 subsection for the failure of the Administrator to file an

20 action under section 7, before the expiration of 10 days

21 after such notification.

22 N^otice under this subsection shall be given in such manner

23 as the Administrator shall prescribe by rule.

24 (c) General.— (1) In any action under this section,

139

1 the Administrator, if not a party, may inteiTene as a matter

2 of right.

3 (2) The court, in issuing any final order in any action

4 brought pursuant to subsection (a), may award costs of suit

5 and reasonable fees for attorneys and expert witnesses if the

6 court determines that such an award is appropriate. Any

7 court, in issuing its decision in an action brought to review

8 such an order, may award costs of suit and reasonable fees

9 for attorneys if the court determines that such an award is

10 appropriate.

11 (3) Nothing in this section shall restrict any right which

12 any person (or class of persons) may have under any statute

13 or common law to seek enforcement of this Act or any rule

14 under this Act or to seek any other relief.

15 (d) Consolidation. — When two or more civil actions

16 brought under subsection (a) involving the same defendant

17 or plaintiffs and the same issues or violations are pending

18 in two or more judicial districts, such pending actions, upon

19 application of such defendant or plaintiff to such actions

20 which is made to a court in which any such action is

21 brought, may, if such court in its discretion so decides, be

22 consolidated for trial by order (issued after giving all parties

23 reasonable notice and opportunity to be heard) of such court

24 and tried in —

140
84

1 ( 1 ) any district which is selected by such defendant

2 or plaintiff and in which one of such actions is pending.

3 (2) a district which is agreed upon by stipulation

4 between all the parties to such actions and in which one

5 of such actions is pending, or

g (3) a district which is selected by the court and

7 in which one of such actions is pending.

8 The court issuing such an order shall give prompt notification

9 of the order to the other courts in which the civil actions con-

10 solidated under the order are pending.

11 citizens' petitions

12 Sec. 21. (a) In General. — Any person may petition

13 the Administrator to issue a rule or order, or to take other

14 action under this Act, the purpose of which is to protect

15 against an unreasonable risk of injury to health or the

16 environment.

17 (b) Peoceduees.— ( 1 ) Such petition shall be filed in

18 the principal office of the Administrator and shall set forth

19 the facts which it is claimed estabhsh that such rule, order, or

20 other action is necessary.

21 (2) The Administrator may hold a public hearing or

22 may conduct such investigation or proceeding as the Admin-

23 istrator deems appropriate in order to determine whether or

24 not such petition should be granted.

25 (3) Within 90 days after filing of a petition de-

141

1 _ scribed in paragraph ( 1 ) , the Administrator shall either

2 grant or deny the petition. If the Administrator grants

3 such petition, the Administrator shall promptly commence

4 an appropriate proceeding to comply with such petition. If

5 the Administrator denies such petition, the Administrator

6 shall publish in the Federal Register the Administrator's rea-

7 sons for such denial.

8 (4) (A) If the Administrator denies a petition filed

9 under this section (or if the Administrator fails to grant or

10 deny such petition within the 90-day period), the peti-

11 tioner may commence a civil action in a United States dis-

12 trict court to compel the Administrator to initiate the action

13 requested. Any such action shall be filed within 60 days

14 after the Administrator's denial of the petition or, if the Ad-

15 ministrator fails to grant or deny the petition within 90

16 days after filing the petition, within 60 days after the ex-

17 piration of the 90-day period.

18 (B) If the petitioner can demonstrate to the satisfaction

19 of the court, by a preponderance of the evidence in a de novo

20 proceeding before such court, that the action requested in the

21 petition conforms to thfe applicable requirements of this Act,

22 the court shall order the Administrator to initiate the action

23 requested by the petitioner.

24 (C) The court in issuing any final order in any action

25 brought pursuant to subparagraph (A) , may award costs of

S. 3149—7

142

-j^ suit and reasonable fees for attorneys and expert witnessjes

2 if the coui't determines that such an award is appropriate,

o Any court, in issuing its decision in an action brought to

4 review such an order, may award costs of suit and reason-

5 able fees for attorneys if the court determines that such an
Q award is appropriate.

ij (5) The remedies under this section shall be in addi-

g tion to, and not in lieu of, other remedies provided by law.

9 NATIONAL DEFENSE WyVIVER

Sec. 22. The Administrator shah waive comphance

-^l with any provision of this Act upon request of the Secretary

22 of Defense and upon a determination by the President that

;j^3 the requested waiver is necessary in the interest of national

14 defense. The Administrator shall maintain a written record

35 of the basis upon which such waiver was granted and make

16 such record available for in camera examination when relc-

17 vant in a judicial proceeding under this Act. Upon the is-

18 suance of such a w^aiver, the Administrator shall publish in

19 the Federal Register a notice tliat the waiver was granted

20 for national defense purposes, unless, upon the request of

21 the Secretary of Defense, the Administartor determines to

22 omit such publication because the publication itself would

23 be contrary to the interests of national defense, in which

24 event the Administi-ator shall su])mit notice thereof to the

143

2 Armed Services Committees of the Senate and the House of

2 Representatives.

3 EMPLOYEE PROTECTION

4 Sec. 23. (a) Geneeal. — No employer may discharge

5 any employee or otherwise discriminate against any em-
Q ployee with respect to the employee's compensation, terms,
tj conditions, or privileges of employment because the employee
g (or any person acting pursuant to a request of the employee)
Q has —

(1) commenced, caused to be commenced, or is
about to commence or cause to be commenced a pro-

j2 ceeding under this Act;

13 (2) testified or is about to testify in any such pro-

14 ceeding ; or

15 (3) assisted or participated or is about to assist or

16 participate in any manner in such a proceeding or in

17 any other action to carry out the purposes of this Act.

18 (b) Remedy. — (1) Any employee who believes that

19 he or she has been aisciiarged or otherwise discriminated

20 against by any person in violation of subsection (a) of this

21 section may, within 30 days after such alleged violation

22 occurs, file (or have any person file on the employee's

23 behalf) a complaint with the Secretary of Labor (herein-

24 after in this section referred to as the "Secretary") alleging

144

1 such discharge or discrimination. Upon receipt of such a

2 complaint, the Secretary shall notify the person named in

3 the complaint of the filing of the complaint.

4 (2) (A) Upon receipt of a com})laiiit filed under para-

5 graph ( 1 ) , the Secretary shall conduct an investigation of the

6 violation alleged in the complaint. Within 30 days of the

7 receipt of such complaint, the Secretary shall complete such

8 investigation and shall notify in writing the complainant

9 (and any person acting on behalf of the complainant) and

10 the person alleged to have committed such violation of the

11 results of the investigation conducted pursuant to this para-

12 graph. Within 90 days of the receipt of such complaint the

13 Secretary shall, unless the proceeding on the complaint is

14 terminated by the Secretary on the basis of a settlement

15 entered into by the Secretary and the person alleged to have

16 committed such violation, issue an order either providing

17 the relief prescribed by subparagraph (B) or denying the

18 complaint. An order of the Secretary shall be made on the

19 record after notice and opportunity for agency hearing. The

20 Secretary may not enter into a settlement terminating a

21 proceeding on a complaint without the participation and

22 consent of the complainant.

23 (B) If in response to a complaint filed under paragraph

24 (1) the Secretary detemiines that a violation of subsection

145

1 (a) of this section has occurred, the Secretary shall order (i)

2 the person who committed such violation to take aflSrmative

3 action to abate the violation, (ii) such person to reinstate

4 the complainant to the complainant's former position to-

5 gather with the compensation (including back pay) , terms,

6 conditions, and privileges of the complainant's employment,

7 (iii) compensatory damages, and (iv) where appropriate,

8 exemplary damages. If such an order is issued, the Secre-

9 tary, at the request of the complainant shall assess against

10 the person against whom the order is issued a sum equal

11 to the aggregate amount of all costs and expenses (including

12 attorney's fees) reasonably incurred, as determined by the

13 Secretary, by the complainant for, or in connection with,

14 the bringing of the complaint upon which the order was
35 issued.

16 (c) Review. — (1) Any person adversely affected or

17 aggrieved by an order issued under subsection (b) may

18 obtain review of the order in the United States Court of

19 Appeals for the circuit in which the violation, with respect

20 to which the order was issued, allegedly occurred. The peti-

21 tion for review must be filed within 60 days from the

22 issuance of the Secretary's order. Review shall conform to

23 chapter 7 of title 5 of the United States Code.

24 (2) An order of the Secretary, with respect U) which

146

1 review could have been obtained under paragraph ( 1 ) , shall

2 not be subject to judicial review in any criminal or other

3 civil proceeding.

4 (d) Enforcement — ( 1 ) Whenever a person has

5 failed to comply with an order issued under subsection (b)

6 (2), the Secretary shall file a civil action in the United

7 States distiict court for the district in which the violation

8 was found to occur to enforce such order. In actions brought

9 under this subsection, the district courts shall have jurisdic-

10 tion to grant all appropriate relief, including injimctive relief

11 and compensatory and exemplary damages. Civil actions

12 brought under this subsection shall be heard and decided

13 expeditiously.

14 (2) Any nondiscretionary duty imposed by this section

15 is enforceable in a mandamus proceeding brought under sec-

16 tion 1361 of title 28, United States Code.

17 (e) Exclusion. — Subsection (a) of this section shall

18 not apply with respect to any employee who, acting with-

19 out direction from the employee's employer (or any agent of

20 the employer) , deliberately causes a violation of any require-

21 ment of this Act.

22 (f) Employment Effects.— (1) The Administrator

23 shall conduct continuing evaluations of the potential loss or

24 shifts of employment which may result from the issuance of

147

1 any rule or order under this Act, including, where appro-

2 priate, investigating threatened plant closures or reductions

3 in employment allegedly resulting from such rule or order.

4 (2) Any employee who is discharged or whose employ-

5 ment is otherwise interrupted, or is threatened with discharge
G or such interruption, or otherwise discriminated against by

7 any person because of the results of an}- rule or order issued

8 under this Aet, or a representative of such employee, may

9 request the Administrator to conduct a full investigation of

10 the matter. The Administrator shall thereupon investigate

11 the matter and, at the request of any interested party, shall

12 hold a pubhc hearing on not less than 5 days notice, and

13 shall at such hearings require the parties, including the em-
11 ployer involved, to present information relating to the actual
13 or potential effect of such rule or order on employment and

16 on any alleged discharge, interruption of employment, or

17 other discrimination and tlie detailed reasons or justification

18 therefor. Any such hearing shall be of record and shall be

19 conducted in accordance with section 554 of title 5, United

20 States Code.

21 (3) Upon receiving the report of any such investigation,
1:2 the Administrator shall make findings of fact as to the effect

23 of such rule or order on employment and the alleged dis-

24 charge, interruption of employment, or discrhnination and

148

1 shall make such recommendations as he deems appropriate.

2 Such report, findings, and recommendations shall be avail-

3 able to the public.

4 (4) Nothing in this subsection shall be construed to

5 require the Administrator to modify or withdraw any rule or

6 order issued under this Act.

7 STUDIES

8 Sec. 24. (a) Indemnification. — The General Ac-

9 counting Office shall conduct a study of all Federal laws

10 administered by the Administrator for the pui'pose of deter-

11 mining whether and under what conditions, if any, indem-

12 nification should be accorded any person as a. result of any

13 action taken by the Administrator under any such law. The
34 study shall —

15 (1) include an estimate of the probable cost of any

16 indemnification progmms which may be recommended;

17 (2) include an examination of all viable means of

18 financing the cost of any recommended indenmification ;

19 and

20 (3) be completed and submitted to Congress not

21 less than 2 years from the date of enactment of this Act.

22 (b) Classification, Storage, and Keteieval.—

23 The Council on Environmental Quality, in consultation

24 with the Administrator, the Secretary of Health, Edu-

25 cation, and Welfare, the Secretary of Commerce, and the

149

1 heads of otlier appropriate Federal departmeiits or agen-

2 cies, shall coordinate a study of the feasibihty of estabUshing

3 ( 1 ) a standard classifioation system for chemical substances

4 and related substances, and (2) a standard means for

5 storing and for obtaining rapid access to information re-

6 specting such substances. A report on such study shall be

7 completed and submitted to Congress not later than 18

8 months after the date of the enactment of this Act.

9 ADMINISTRATION OF ACT

10 Sec. 25. (a) Cooperation of Federal Agencies.—

11 Upon request by the Administrator, each Federal depart-

12 ment and agency is authorized —

13 (1) to make its services, personnel, and facilities

14 available (with or without reimbursement) to the Ad-

15 ministrator to assist the Administrator in the admin-

16 isti*ation of this Act ; and

17 (2) to furnish to the Administrator such informa-

18 tion, data, estimates, and statistics, and to allow the

19 Administrator access to all information in its possession

20 as the Administrator may reasonably determine to be

21 necessary for the admmstration of this Act.

22 (b) Fees. — The Administrator may, by rule, require

23 the payment of a reasonable fee from any person required

24 to submit data under section 4 or 5 of this Act to de-

150

1 fray the cost of administering this Act. Such rules shall not

2 provide for any fee in excess of $2,500. In settiag such a fee,

3 the Administrator shall take into account the ability to pay

4 of the person required to submit the data and the cost to the

5 Administrator of reviewing such data. Such rules may pro-

6 vide for sharing such a fee in any case in which the expenses

7 of testing are shared under section 4 or 5 of this Act.

8 (c) Action With Respect to Categobies — ( 1 )

9 Any action which may be taken by the Administrator under

10 any provision of this Act with respect to a chemical sub-

11 stance or mixture may be taken by the Administrator in

12 accordance with that provision with respect to a category

13 of chemical substances or niixt,ures. Whenever the Admmis-

14 trator takes action under a provision of this Act with respect

15 to a category of chemical substances or mixtures, any refer-

16 ence in this Act to a chemical substance or mixture (insofar

17 as it relates to such action) shall be deemed to be a refer-

18 ence to all chemical substances or mixtures in such category.

19 (2) For purposes of paragraph (1) :

20 (A) The term ''categoiy of chemical substances"

21 means a group of chemical substances the members of

22 which are similar in molecular structure, in physical,

23 chemical, or biological properties, in use, or in mode of

24 entrance into the human body or into the environment,

25 or the members of which are in some other wa}^ s.iiitablc

151

1 for classification as such for purposes of this Aot, except

2 that such term does not mean a group of chemical sub-

3 stances which are grouped together solely on the basis

4 of their being new chemical substances.

5 (B) The term ''category of mixtures" means a

6 group of mixtures the members of which are similar in

7 molecular sti'ucture, in physical, chemical, or biological

8 properties, in use, or in mode of entrance into the human

9 body or into the environment, or the members of which

10 are in some other way suitable for classification as such

11 for purposes of this Act.

12 (d) Statement of Purpose and Justification. —

13 Any proposed or final rule or order issued under this Act

14 shall be accompanied by a statement of purpose and justifi-

15 cation. Such a statement shall be considered part of the

16 ''record of the proceedings" for purposes of judicial review

17 under section 19 (a) .

18 (e) Assistant Administrator.— The President, by

19 and with the advice and consent of the Senate, shall appoint

20 an Assistant Administrator for Toxic Substances of the Envi-

21 ronmental Protection Agency. Such Assistant Administrator

22 shall be a qualified individual who is, by reason of back-

23 ground and experience, especially qualified to direct a pro-

24 gram concerning the effects of chemicals on human health

25 and the environment. Such Assistant Administrator shall be

152

1 responsible for the collection of data, the preparation of

2 studies, and the making of recommendations to the Adminis-

3 trator for regulatory and other actions to carry out the

4 purposes, and to facihtate the administration of this Act.

5 AUTHORIZATION FOR APPROPRIATIONS

6 Sec. 26. (a) In General.— There is authorized to be

7 appropriated to the Administrator, for purposes of carrying

8 out this Act, $11,100,000 for the fiscal year ending June 30,

9 1976, $2,600,000 for the period beginning July 1, 1976 and

10 ending September 30, 1976, and $10,100,000 for the fiscal

11 year ending September 30, 1977. No part of the funds so

12 authorized to be appropriated shall be used to construct any

13 research laboratories.

14 (b) Budget Requests.— Whenever the Administra-

15 tor directly or indirectly submits, in connection with this

16 Act, any budget requests, supplemental budget estimates,

17 legislative recommendations, prepared testimony for con-

18 gressional hearings, or comments on legislation to the Presi-

19 dent or to the Office of Management and Budget, or per-

20 sons acting on their behalf, the Administrator shall con-

21 currently transmit a copy thereof to the Congress. No officer

22 or agency of the United States shall have any authority to

23 require the Administrator to submit budget requests or esti-

24 mates, legislative recommendations, prepared testimony for

25 congressional hearings, or comments on legislation relating

153

1 to this Act to any officer or agency of the United States for

2 approval, comments, or review, prior to the submission of

3 such requests, estimates, recommendations, testimony, or

4 comments to the Congress.

5 ANNUAL REPORT

6 Sf-C. 27. The Administrator shall prepare and submit

7 to the President amir tUe Congress on or before January 1 of

8 each year a comprehensive report on the administration of

9 this Act during the preceding fiscal year. Such report shall

10 include —

11 (1) a list of the testing required under section 4

12 during the year for which the repor^ is made and an

13 estimate of the costs incurred during such year by the
1^ persons required to perform such tests;

1^ (2) the number of notices received during such year

1^ under section 5, the number of such notices received dur-
ing such year under such section for chemical substances
and mixtures subject to a section 4 rule, and a summary

19 of any" action taken during such year under section 5 (e) ;

20 (3) a list of rules issued during such year under

21 section 6;

22 (4) a list, with a brief statement of the issues, of

23 coni])]eted or pending' judicial or enforcement actions
2- under this Act during such year;

79-313 0 - 77 - 11

154

1 (5) a summary of major problems encountered in

2 the administration of this Act; and

3 (6) such recommendations for additional legislation

4 as the Administrator deems necessary to carry out the

5 purposes of this Act.

155

Calendar No. 668

94th Congbess \ (sii^-iTii- / Repoet

2d Sesnon / si>.>Ait -j^ j^.^, 94-098

TOXIC SUBSTxVXCES CONTROL ACT

REPORT

OF THE

SENATE COMMITTEE ON COMMERCE

S. 3149
together with
ADDITIONAL VIEWS

TO REGULATE COMMERCE AND PROTECT HUMAN HEALTH
AND THE ENVIRONMENT BY REQUIRING TESTING AND
NECESSARY USE RESTRICTIONS ON CERTAIN CHEMICAL
SUBSTANCES, AND FOR OTHER PURPOSES

Mabch 16, 1976. — Ordered to be printed

57-010

U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 1976

156

CONTENTS

Pac«

Purpose and brief description 1

Background and needs 3

Description 6

Responses to arguments 10

Legislative background 13

Section-by-section analysis 14

Sec. 1. Short title and table of contents . 14

Sec. 2. Findings, policy, and intent 14

Sec. 3. Definitions and exclusions 14

Sec. 4. Testing of chemical substances and mixtures 15

Sec. 5. Premarket notification of chemical substances 17

Sec. 6. Regulation of hazardous chemical substances and mixtures 20

Sec. 7. Imminent hazards 21

Sec. 8. Reporting and retention of information 21

Sec. 9. Relationship to other laws 23

Sec. 10. Research, collection, dissemination, and utilization of data.. 23

Sec. 11. Inspections and subpoenas 24

Sec. 12. Exports 24

Sec. 13. Entry into customs territory of the United States 25

Sec. 14. Disclosure of data 25

Sec. 15. Prohibited acts 25

Sec. 16. Penalties 26

Sec. 17. Specific enforcement and seizure 26

Sec. 18. Preemption 27

Sec. 19. Judicial review 27

Sec. 20. Citizen's civil action 28

Sec. 21. Citizen's petitions : 29

Sec. 22. National defense waiver 29

Sec. 23. Employee protection 29

Sec. 24. Studies ^ 30

Sec. 25. Administration of act 30

Sec. 26. Authorization for appropriations 31

Sec. 27. Annual report 31

Changes in existing law 32

Estimated costs 32

Record votes in Committee 32

Text of S. 3149 as reported - 33

Agency comments 73

Additional views of Mr. Baker 89

(HI)

157

Calendar No. 668

<)4th Congress ) SENATE ( Report

2d Session f (No. 94-698

TOXIC SUBSTANCES CONTROL ACT

March 16, 1976. — Ordered to be printed

Mr. Magnusox, from the Committee on Commerce,
submitted the following

REPORT

together with
ADDITIONAL VIEWS

[To accompany S. 3149]

The Committee on Commerce having considered the bill (S. 3149)
to regulate commerce and protect human health and the environment
by requiring testing and necessary use restrictions on certain chemi-
cal substances, and for other purposes, reports favorably thereon and
recommends that the bill do pass.

Purpose axd Brief Descriptiox

The purpose of S. 3149 is to prevent unreasonable risks of injury
to bealtli or the environment associated with the manufacture, process-
ing, distribution in commerce, use, or disposal of chemical substances.
The bill is designed to fill a number of regulatory gaps which cur-
rently exist. They are :

1. PREM arret review

"Wliile certain environmental health statutes may be used to protect
healtli and the environment from chemical substances, only pesticides,
drugs, and food additives undergo j^remarket scrutiny prior to first
manufacture. The Clean Air Act (77 Stat.. 392), the Federal Water
Pollution Control Act (GO Stat. 755). the Occupational Safety and
Health Act (84 Stat. 1590), and the Consumer Product Safety Act
(Sf) Stat. 1207), do not provide for this type of premarket scrutiny.

2. DIRECT REGULATION OF CHEMICALS

While air and water laws authorize limitations on discharges and
emissions, the Occupational Safety and Health Act authorizes the
establishment of ambient air standards for the workplace, and the
Consumer Product Safety Art authorizes standards with respect to

(1)

158

consumer products, there are no existin^r statutes which authorize the
direct control of industrial cliemicals themselves for their health or
environmental effect (except section 211 of the Clean Air Act, which
authorizes the re<xulation of fuel additives).

^^Hiile these otlier authorities will in many cases be sufficient to
adequately protect health and the environment, the alternative of
preventing or regulating the use of the chemical in the first instance
may be a far more effective way of dealing with the hazards. If
expensive sewage treatment facilities can be avoided, for example,
through removing dangerous materials from household and indus-
trial wastes, the authority to do so ought to be provided.

3. COXSIDERATION OF ALL THE RISKS

"^Vhile individual agencies may be authorized to regulkte occu-
pational, environmentah or direct consumer hazards with respect to
a chemical substance, there is no agency which has the authority to
look comprehensively at the hazards associated with the chemical.
Existing authority allows the agencies to only look at the hazards
within their jurisdiction in isolation from other hazards associated
with the same chemical. The bill would grant the Environmental Pro-
tection Agency the authority to look at the hazards in total.

4. COLLECTION OF TEST DATA

The committee bill also provides a mechanism whereby information
with respect to health and environmental effects can be collected from
manufacturers and processors of chemical substances. While other
statutes provide regulatory authority, they do not place the responsi-
bility for gathering information in support of the regulatory program
squai^ly with persons who are responsible for the manufacture or
processing of the chemical substance or mixtures.

Specificallv, the bill provides:

( 1 ) That manufacturers of neio ch emical suhsfances give notifi-
cation to EPA 90 days in advance of first manufacture and that
test data accompany that notification if required by EPA. The
provision is not applicable to research chemicals unless EPA
specifically includes any such chemical.

(2) That the EPA Administrator require manufacturers to test
or have tested those chemical substances which he determines
may present an unreasonable risk of injury to health or the
enviromnent or those for which significant human or environ-
mental exposure takes place or will take place. The provision is
applicable both to new and existing chemical substances.

(3) Manufacturers and processors of chemical substances are
required to maintain certain records and reports to better enable
the Administrator to determine if unreasonable risks exist. Im-
portantly, m.anufacturers must maintain with the Administrator
lists of health and safety studies conducted, whether or not they
have been conducted as a result of this legislation. The Adminis-
trator is authorized to require the submission of any study on
the list.

159

(4) Citizens are authorized to bring suits to enjoin certain
violations and to require the Administrator of EPA to perform
his mandatory dutie.s. A citizens' petition provision is also pro-
vided whereby citizens may receive judicial review of petitions
to EPA which were denied or not act^d upon.

Background and Needs

The last century has witnessed the ev^er-accelerating growth of the
cliemical industry. Sales now exceed $100 billion a year. This industry
has developed a vast new array of chemicals. In fact, it is estimated
that there are presently 2 million recognized chemical compoundb
in existence with nearly 2r>0,000 new compounds produced each year.
While most of these compounds will never be conmiercialized, the
Environmental Protection Agency estimates that approximately 1,000
new chemicals each year will find their way into the marketplace and
subsequently into the environment through use or disposal.

As the industry has grown, we have become literally surrounded
by a man-made chemical environment. We utilize chemicals in a ma-
jority of our daily activities. We continuall}' wear, wash with, inhale,
and ingest a multitude of chemical substances. Many of these chem-
icals are essential to protect, prolong, and enhance our lives. Yet, too
frequently, we have discovered that certain of these chemicals present
lethal health and environmental dangers.

In 1971, the Council on Environmental Quality in a report entitled
"Toxic Substances'- concluded that regulatory mechanisms to control
toxic chemicals were ''inadequate." This report was the impetus for
the original Toxic Substances Control Act legislation.

After 15 days of hearings and extensive analysis over the last 5
years, the Toxic Substances Control Act has evolved into a compre-
hensive measure to protect the public and the environment from ex-
posure to hazardous chemicals. The legislation would assure that chem-
icals receive careful premarket scrutiny before they are manufactured
or distributed to the public. This provision would end the present
situation where chemicals can be marketed without notification of any
governmental body and without any requirement that they be tested
for safety. Thus, this provision would no longer allow the public or the
environment to be used as a testing ground for the safety of these
products.

In a recent speech supporting toxic substances control legislation,
Russell E. Train, the Administrator of the Environmental Protec-
tion Agency, pointed out that —

Most Ampricans had no idea, nntil relatively recently, that they were living
so dangerously. They had no idea that when they went to work in the morning.
OP when they ate their breakfast— that when tliey did the things they had to do
to earn a living and keep themselves alive and well— that when they did things
as ordinary, as innocent and as essential to life as eat, drink, breathe or touch,
they oouTd. in fact, be laying their lives on the line. They had no idea that, with-
out their knowledge or consent, they were often engaging in a grim game of
chemical roulette whose result they would not know nntil many years later.

Dr. Train's view is a reflection of the fact that in the last few years
the list of commonly utilized and widely dispersed chemicals that

160

have been found to be potentially significant health and environmental
dangers has been constantly growing. A partial list includes:

(1) Kepone,. which has been implicated in causing brain damage
and other nervous system disorders ;

(2) vinyl chloride, arsenic, and asbestos, all found to be potentially
extremely potent cajicer-eausing agents in man ;

(3) mercury, lead, and other heavy metals ;

(4) PCB's which have been found to cause liver cancer in rats and
to have contaminated numerous fish stocks throughout the United
States; and

(5) fluorocarbons. propellants in aerosols and coolants in refrigera-
tors and air-conditionei-s, suspected of depleting the Earth's ozone
layer which protects humans from excessive ultraviolet radiation that
can cause skin cancer.

Furthermore, the interaction of chemical substances in some cases,
makes these dangers multiplicative rather than additive. Dr. Irving
Selikoff, of the Mount Sinai Medical School, for example, pointed out
that asbestos workers who are nonsmokers do not have an appreciably
higher lung cancer rate than the population at large. However, Dr.
Selikoff noted that if an asbestos worker smokes, his chances of getting
lung cancer are eight times greater than the average cigarette smoker
and are 92 times greater than an individual who is neither an asbestos
worker or a smoker. Thus, the risks appear to be multiplied by these
interactions.

Russell Peterson, Chairman of the Council on Environmental Qual-
ity, after analyzing these chemical dangers concluded at last year's
hearings, "Toxic substances legislation is probably the most impor-
tant environmental legislation now before the Congress." Many doctors
and scientists concur with Dr. Peterson noting that controlling toxic
chemicals in the environment is one of the crucial health requirements
facing this Xation. Dr. David Rail, Director of the National Institute
of Environmental Health Sciences of the National Institutes of Health,
has stated, for example :

Recent experience with vinyl chloride, bi.schloromethyl ether, methj'Ibut.vl
ketone, and sulphuric acid mist indicate that these compounds are not theoretical
threats, but known causes of illness and death. Many of these compounds are
toxic to man in relatively low concentrations. Man is assaulted by these com-
pounds alone and in combination from multiple sources. This problem constitutes
possiUy the major health hazard of this decade. (Italics added.)

Cancer, which was projected to kill as many Americans in 1975 as
all the battle deaths in Vietnam, Korea, and the Second World War
combined, appeal's particularh^ susceptible to a preventive approach
through control of toxic substances in the environment. The National
Cancer Institute, for example, estimates that 60 to 90 percent of the
cancers occurring in this country are a result of environmental con-
taminants. Furthermore, the National Cancer Institute has plotted
the incidence of cancer around the industrial centers of the United
States. Almost without exception the industrial centers, where indus-
trial chemicals are obviously found in largest concentrations, had the
highest incidence of cancer.*^ Thus, the Toxic Substances Control Act,
which provides authority for increased testing of chemicals for their
cancer-causing effects, can serve as an early warning system to si(rnal
potential dangers before products are widely dispersed and irretriev-
able societal danger has been unleashed.

161

Toxic chemicals have also been implicated in causing birth defects
and genetic damage. The National Foundation-March of Dimes re-
cently wrote to Senator Magnuson in support of toxic substances
I legislation stating :

I More than 200,000 infants are born with physical or mental damage feach year,
a staggering 7 percent of all births * * * A total of 15 million Americans have
birth defects serious enough to drastically affect their daily lives * ♦ * It is
with alarm that our attention is drawn to some aspects of modern technology
which work counter-productive to our aims. Each year billions of pounds of chem-
icals which are virtually untested and unregulated are produced in industrial
processes and used in commercial products. Exi)erience with vinylchloride has
shown it to be a highly toxic substance which experimentally can cause cancer
and birth detects ; but this experience cajne only with its burden of proof ou
the public. We look now to preventative testing of toxic substances in industrial

I production prior to manufacture or distribution as one critical means to reduce

j exogenous causes of birth defects.

j In order to protect against these dangers, the proposed Texic Sub-
I stances Control Act would close a number of major regulatory gaps,
for while certain statutes, including the Clean Air Act, the Federal
I Water Pollution Control Act, the Occupational Safety and Health
I Act, and the Consumer Product Safety Act, may be used to protect
health and the environment from chemical substances, none of these
\ statutes provide the means for discovering adverse effects on health and
environment before manufacture of new chemical substances. Under
these other statutes, the Government regulator's only response to
chemical dangers is to impose restrictions after manufacture begins.

The most effective and efficient time to prevent unreasonable risks
to public health or the environment is prior to first manufacture. It is
at this point that the costs of regulation in terms of human suffering,
I jobs lost, wasted capital expenditures, and other costs are lowest. Fre-
quently, it is far more painful to take regulatory action after all of
tliese costs have been incurred. For example, the hazards associated with
vinyl chloride have made headlines in recent months. Vinyl chloride
has been implicated as causing liver cancer in industrial workei^. At the
same time the country has grown extremely reliant on the plastics
which are produced from the chemical. In fact, 1 percent oi our gross
national product is associated with the \anyl chloride industry. Obvi-
ously, it is far moi-e difficult to take regulatory action against this
chemical now, than it would have been had the dangers been known
earlier when alternatives could have been developed and polyvinyl
chloride plastics not become such an intrinsic pait of our way of life
in this country.

The proposed Toxic Substances Control Act also provides a far more
effective mechanism to protect against dangerous chemical materials
contained in consumer and industrial products. While air and water
pollution laws authorize limitations on discharges and emission and
the Occupational Safet v and Health Act authorizes workplace ambient
standards, there are no statutes (except the fuel additives provisions of
the Clean Air Act ) which authorize the direct control of such chem-
icals for their health or environmental effects.

The regulation of the discharge of excessive levels of mercury into
the environment is an example of the need for such controls. Recently,
there has been growing concern about mercury pollution due to indus-
trial discharges. Yet, testimony has indicated that an even greater

162

threat of pollution may be posed by the presence of mercury in such
consumer products as paint, home thermometers, spon^s, and a variety
of other products. Industrial pollution often can be pinpointed and cor-
rective action rapidly taken ; however, it is nearly impossible to prevent
an individual householder from disposing of products containing toxic
substances either down the drain or out with the garbage. While many
dangerous materials can be removed from municipal sewage, many
others cannot, therefore, it seems far more prudent to provide authority
to limit the amounts of dangerous materials in consumer products than
to allow them to escape into a municipal sewage plant or to vainly ask
the householder not to dispose of them. A prime purpose of the pro-
posed Toxic Substances Control Act is to provide authority for such
regulatory controls.

Another important provision would provide regulators timely access
to information regarding health and safety studies concerning chem-
icals covered by the Act. The importance of this provision was demon-
strated in hearings of the Subcommittee on the Environment of the
Senate Commerce Committee, where witnesses made detailed allega-
tions that certain groups within the chemical industry had knowledge
of the cancer-causing potential of vinyl chloride well in advance of
the time that this information was released to the Government or the
public. Similar charges were made that data was suppressed which
suggested that industrial workers exposed to the chemical BCME
were experiencing unusually high lung cancer rates. This legislation
will provide the authority for EPA to gather this kind of information
with respect to existing studies as well as studies which may be begun
in the future.

The tim^ has passed where human health and the environment is
protected only after serious injury has occurred. As Russell Train has
stated:

It is time we started putting chemicals to the test, not people. It is time we
gave the people of this country some reason to believe that every time they take
a breath or eat or drink or touch, they are not taking their life into their hands.

The Committee bill, which contains provisions to regulate chemical
hazards, will help provide this needed assurance.

Description

1. testixg of chemical stjbstances

There are two multi-part bases under which the Administrator
must require that testing be conducted on a cliemical substance or
mixture. First, if the manufacturer, processing, distribution in com-
merce, use, or disposal (a) may present an unreasonable risk, (b) there
are insufficient data or experience upon which to judge the effects
upon health and the environment, and (c) testing is necessary to
develop data, the Administrator must require testing.

Second, if the Administrator finds that the chemical substance
or mixture may present significant human or environmental exposure
because it is or will be produced in substantial quantities or for other
reasons, and that the substance or mixture may perhaps present an ad-
verse effect on health and the requirements of (b) and (c) above are

163

met, the Administrator must require testing. The finding with respect
to an adverse eflfect is to be presumed if the Administrator has no
reliable data or experience available to him.

In addition, the Administrator must consider the reasonably ascer-
tainable costs and other burdens associated with conducting tests in
light of the possible risks of injury to healtli or the environment.
These findings are to be published in the Federal Register.

An eight member Federal advisory committee is established to de-
velop a priority list of chemicals which it recommends to the Admin-
istrator for testing. The membei-s of the committee are made up of
Federal officials who either have regulatory responsibility in the area
of chemical substances or liave expertise with respect to testing needs.

Within 12 months after the date of inclusion of a chemical substance
or mixture on the priority list, the Administrator is required to either
(a) initiate a rulemaking proceeding to require testing or (b) pub-
' lish in the Federal Register his reasons for not initiating such a
proceeding.

2. PREM ARRET NOTIFICATIOX

j At least 90 days prior to the first manufacture (for commercial
purpose) of a new chemical substance, manufacturers are to give
notice to the Administrator. The notice is to contain information with
i respect to the identity of the substance, uses, estimates of amount to be
f l)roduced, description of byproducts, a list of test data, and estimates
of the number of employees who will be exposed to the substance.

If a testing requirement applicable to the new cliemical has been
established (see discussion of "Testing of Chemical Substances" above)
the notification nmst be accompanied by the test data required.

The 90-day premarket notification period may be extended by the
Administrator for an additional 90 daj^s for good cause shown.

During the premarket notification period, the Administrator is
authorized to issue an order which may restrict or prohibit the manu-
facturer of a new chemical substance on either of two bases :

(a) that a test requirement is necessary (or should be revised
or added to) ; or

(b) that a restrictive rule is appropriate.

Orders issued during the premarket notification period are to uc
immediately effective and will trigger the appropriate rulemaking pro-
visions under, section 6 (restrictions) or section 4 (testing require-
ments). A pro\asion to expedite rulemaking under these provisions is
provided.

If the Administrator determines that orders during the premarket
notification period are inappropriate or that action should not be
taken under the imminent hazards authority of section 7, he must
publish a statement of his reasons in the Federal Register.

The premarket notification provisions would also apply to significant
new uses of existiiig chemical substances.

Premarket notification would not take place with respect to mix-
tures or experimental or research chemicals unless the Administrator
specifically includes any such chemical for purposes of the premarket
notification.

The Administrator is also authorized to exempt persons from
premarket notification for test marketing purposes or specially limited

164

purposes or with respect to chemical substances which are inter-
mediate reaction products fofmed during the manufacture of other
chemical substances and for which there is no exposure to human
beings or tlie environment.

3. RESTRICTIVE AUTHORITY

Kestrictive requirements may be prescribed for any chemical sub-
stance or mixture which presents or is likely to present an unreasonable
risk of injury to health or the environment. Remedies available to the
Administrator range from outright prohibitions to simple labeling
requirements.

In promulgating rules, the Administrator is to consider all relevant
factors and make findings with respect to them. Included are the
risks to liuman beings and to the environment, the benefits of the
substance or mixture, and the reasonably ascertainable economic
consequences of the rule.

The Administrator is also authorized to seek orders in the district
courts to protect against imminent hazards. Imminent hazards are
defined as substances or mixtures which present an unreasonable risk
of death, serious illness, or serious pei-sonal injury, or serious environ-
mental harm prior to the completion of an administrative hearing or
other proceeding authorized under the bill.

4. REPORTING AND RETENTION OF INFORMATION

The bill authorizes the Administrator to collect information whicli
will prove extremely valuable in gathering information necessary to
assess and take action against chemicals causing unreasonable risks.
Manufacturers or processors may be required to submit pertinent
information with respect to the identity, uses, amounts produced,
byproducts, health effects, and exposure levels of chemical substances.

In addition, lists of health and safety studies conducted by, initiated
by, or known to persons within the chemical industry must be sub-
mitted to tlie Administrator. The Administrator may then require
the submission of any study appearing on the list. This will be valu-
able in avoiding the situations that have occurred in the past with
chemicals like vinyl chloride and BCME where allegations have been
made that the industry and trade associations withheld information
which would have revealed hazards associated with these chemicals
at a much earlier date.

In addition, persons within the chemical industry, and liability
insurers of these pei*sons, are required to submit any information to
the Administrator which supports the conclusion that an unreason-
able risk to health or the environment is presented.

5. RELATIONS j^nP TO OTHER FEDERAL LAWS

If an unreasonable risk may be prevented or reduced sufficiently by
other Federal laws, the Administrator must request the agency
administering the law to issue an order declaring whether or not

165

such a risk is presenlod. If the agency agrees that such a risk is pre-
sented, it must determine if the risk can be prevented or reduced
to a sufficient extent by action taken under the law administered by it.

If the other Federal agency issues the order declaring that there
is no unreasonable risk or initiates action under the other law, the
Administrator may not take action under this authority to prevent
the unreasonable risk.

With respect to other laws administered by the Administrator, the
Administrator is directed to coordinate his actions with actions taken
under those Federal laws and to use the authority contained in those
laws unless this authority would be more appropriate.

In order to insure that information is gathered and premarket
notification takes place, the restriction on the Administrator's author-
ity would not apply to section 4 (testing) , section 5 (premarket notifi-
cation), or section 8 (reporting and information gathering).

6. CmZEXS PARTICIPATIOX

The bill contains a citizen's suit provision which authorizes suits
against the Administrator where he has failed to perform a nondis-
cretionary duty and against others who are alleged to be in violation
of sections 4 (testing), 5 (premarket notification), or 6(a) (restrictive
rules). The provision is modeled after similar provisions in the Safe
Drinking Water Act (88 Stat. 1660) Consumer Product Safety Act,
Clean Air Act, Federal Water Pollution Control Act, and Noise Con-
trol Act.

In addition, citizens are authorized to petition the Administrator
to take action the purpose of which is to protect against unreasonable
risks of injury to health or the environment. If the Administrator
fails to take action within 90 days on such a petition, or denies it,
judicial review of the denial or failure is authorized. After gathering
evidence in a de novo procedure, the courts would be authorized to
require the initiation of the action requested if the petitioner has
shown that the action requested is justified. The citizen's petition
provision is similar to that contained in the Consumer Product Safety
Act.

7. EMPLOYEE PROTECTION'

Discrimination against any employee who participates in proceed-
ings, testifies in a proceeding, or participates in any other action neces-
sary to carry out the purposes of the legislation is prohibited.

A procedure is provided whereby the Secretary of Labor would
conduct a proceeding and may order the reinstatement of the employee
if violations are found.

In addition, the Administrator is required to continually evaluate
the effects on employment which may result from the issuance of rules
or orders under the bill. If requested by an employee whose employer
has acted against him or her because of any rule or order issued under
this bill, or when such actions are threatened, the Administrator is
required to investigate the matter and to make findings of fact with
re«^pect to such allegations.

166

Responses to Arguments

1. The hill does not contain excessive authority for EPA,

In the major regulatory provisions, section 4 (relating to test re-
quirements) and section 6 (relating to restrictive authority), the
Administrator is directed to consider costs and benefits when deriving
appropriate rules.

Under section 6, the Administrator is required to make findings
with respect to all relevant factors and to publish them in the Federal
Register. This includes the risks to health and the environment, the
benefits of tlie substance or mixture to be regulated, and the reasonably
ascertainable economic consequences of the rule.

Under section 4, the Administrator is required to consider the rea-
sonably ascertainable costs and other burdens associated with conduct-
ing the tests in light of the possible risks of injury to health or the
environment and is required to publish these considerations in the
Federal Register.

The rulemaking provisions of sections 4 and 6 provide an additional
means to prevent improper action by EPA. Under section 4(b) (4) the
Administrator is required to give interested persons an opportunity
for the oral presentation of data, views, or arguments in addition to
the opportunity to make written submissions.

Under the rulemaking provisions of section 6, an informal hearing
must be provided with rights of cross-examination granted in appro-
priate instances.

Of course, judicial review of rules issued is available.

Finally, section 2(c) specifically states that it is the intent of Con-
^rress that the Administrator be reasonable and prudent in his admin-
istration of the bill, and that he is to consider the environmental,
economic, and social impact of actions taken thereunder.

^. The premarJcet notification provisions are not too broad.

If hazards are to be discovered and prevented prior to the first
manufacture of new chemical substances or prior to the imposition of
significant new uses of existing substances, premarket notification is an
essential provision.

Other alternatives to the committee bill now pending in the House
of Representatives, would restrict premarket notification only to those
■chemical substances for which a finding of risk could be made. Thus,
the EPA Administrator would be placed in the position of predicting
not only what new chemical substances might be produced, but their
level of hazard as well. The unpredictable new chemical substance
would be completely missed by this procedure as would those sub-
stances for which hazards information does not exist. Thus, the pre-
market notification provisions' of the committee bill forms the back-
bone of the preventive aspects of health protection sought by this
legislation.

While the EPA Administrator must be given the authority to act
during the premarket notification period to gather more data or to
take appropriate restrictive action, the notification burden itself should
not be onerous. Unless testing has been otherwise required, notification
only consists of reporting routine information which should be in the
Jhands of the manufacturer in the fii-st place. Included is information

167

as to the identity of the product, categories of use, estimates of the
amount to be produced and, insofar as reasonably ascertainaJ>le, to be
produced for each of the categories of use, a description of byproducts,
lists of existing test data, and estimates of the number of persons who
will be exposed in their places of employment.

P^stimates of the number of new chemicals to which this requirement
will be applicable range fi*om several thousand (Manufacturing
Chemists' Association) to around 1,000 (EPA). This is contrasted
with registration of pesticides bv EPA, for example, which numbered
nearly 8,000 in 1975.

3. The Committee hill does not extensively overlap with other Federal
authorities and authority within EPA.

Section 9 of the Committee bill requires the Administrator of EPA
to utilize other Federal laws which he administers unless he determines
that the risk may be more appropriately protected against by utilizing
this authority. The right to use this authority is an alternative that
would be extremely important in certain instances. For example, EPA
should bo allowed to regulate a dangerous chemical substance con-
tained within a consumer product, rather than being required to con-
trol it later through an effluent standard or emissions standard, which
may be a far more inefficient and expensive method of regulation.

This relationship must exist if this legislation is to address the issue
of controlling industrial chemicals as a means of preventing environ-
mental degradation as an alternative to other forms of control.

With respect to statutes not administered by EPA, the Administra-
tor is directed to give notice to other relevant Federal agencies if the
risk associated with a chemical may be prevented or reduced to a suf-
ficient extent by action taken under the other Federal laws not admin-
istered by EPA. The other agency is required to respond to the notice
of the Administrator, but in not less than 90 days. If the other agency
issues an order declaring that there is no unreasonable risk of injury
to health or the environment, or initiates appropriate action under its
own authority, the Administrator has no authority to take restrictive
action under this Act.

In order to elisure that the vital premarket notification, testing,
and reporting requirements are retained, nothing contained in the
provision is to effect that authority or requirements.

Finally, the Administrator of EPA is required to consult and coor-
dinate with the Secretary of Health, Education, and Welfare, and the
heads of other appropriate Federal agencies for the purpose of achiev-
ing the maximum enforcement under this Act while imposing the least
burdens of duplicative requirements.

The entire provision is designed to minimize duplication and overlap
in the regulation of toxic chemicals, while providing EPA with suf-
ficient authority to alert other agencies of chemical dangers where
those other agencies have sufficient regulator}' authority to eliminate
these dangers.

4. The hill minimizes hurdens on small husiness.

The bill contains a number of provisions which provide assurance
that small business will not be overburdened by its requirements. First,
it should be noted that small chemical manufacturers in geneml do

168

not synthesize large numbers of new chemicals. Synthesis of new chem-
icals takes place primarily within the major companies which have the
financial capability to engage in this kind of research. Therefore, most
small chemical companies should not be subject to the premarket noti-
fication requirements of section 5.

There are also provisions which will serve to limit the small com-
panies' financial obligations when testing is required. A cost-sharing
procedure, for example, is provided where a chemical company that
wishes to produce a chemical discovered by someone else shares the
cost of developing the test data. One of the explicitly stated bases for
determining how these costs are to be apportioned is the market shares
of the company which is required to provide reimbursement. A small
company will usually have a smaller market share and therefore the
reimbursement requirements will be minimized.

Also, in each case where restrictive rules are authorized, the Admin-
istrator is required to protect a.orainst "unreasonable risks." In deter-
mining what is an "unreasonable" risk a balancing of ri?ks and bene-
fits is required. The effect of a rule on small business, of course, is one
of the things that the Administrator must weigh in balancing risks
and benefits.

The legislation also allows the Administrator to exclude substances
from any or all provisions of the Act, if such substa.nc^ does not pre-
sent an unreasonable risk. The products developed by small businesses
may be excluded by the Administrator utilizing this provisk)n if such
risks are not presented.

Under the rulemaking procedures of this legislation, compensation
is available to pay attorneys' fees and other costs of representing
persons before EPA who could not otherwise afford it. Small business-
men could well be eligible for such help. Also an amendment accepted
by the committee provides authority to require replacement or re-
purchase by manufacturer or processors of banned or restricted prod-
ucts. This provision will prevent small retailers and wholesalers from
being saddled with large inventories of otherwise unusable products.

5. There is precedent for the de novo procedures contained in the
citizens' petitions provisimis and such procedures are neces-
sary.

The citizens' petitions provision in the legislation is analoirous to
a provision contained in the Consumer Product Safety Act. This sec-
tion will assure that the Environmental Protection Agency is forced
to focus on the provisions of the bill directed at protecting health and
the environment from the dangers of toxic chemicals. The citizens'
petitions provision is limited to petitions "the purpose of which [are]
to protect against an unreasonable risk of injury to health or the en-
vironment." If a citizen can show by a preponderance of the evidence
that the action requested in a citizen's petition conforms to the appli-
cable requirements, then EPA should be required to initiate an action.
It should be noted that in reviewing a denial of the citizen's petition by
the Environmental Protection Agency the court can only require EPA
to initate an action. The court would not be allowed in this situation
to determine the content of a rule or outcome of such a proceeding.

The court, if petitioned, shall conduct a de novo review of any denial
or failure to act on a citizen's petition by the Environmental Protec-
tion Agency. In a judicial review of the Administrator's denial of a

169

citizen's petition or failure to act, there would be no record upon
which the review could be based, and therefore a de novo procedure is
essential to provide the opportunity to develop such a record.

Tlie responsiveness of government is a critical concern and the citi-
zens' petition provision will help to protect against lax administra-
tion of the bill.

6. The economic hurdens that may he imposed as a result of this legis-
lation are not substantial particularly when considered in the
context of the economic^ heaWuand other benefits.

There have been widely varying estimates from the chemical in-
dustry of the total cost to the industry of the legislation. The Dow
Chemical Co., for example, has estimated that the legislation would
cost the chemical industry $2 billion per year. The Manufacturing
Chemists Association estimated tliat these costs would range from $340
million to $1.3 billion per year. The Environmental Protection Agency,
however, estimates that the annual total cost to the chemical industry
from the enactment of this legislation will be far lower and will range
from $80 to $140 million per year.

In order to anal^^ze tlie accuracy of tliese studies, the committee re-
quested the General Accounting Office to examine these estimates. The
General Accounting Office leport to the committee seriously questioned
the high estimates of the Dow and Manufacturing Chemists' Asso-
ciation studies, and stated tliat EPA's estimates Avere more reliable
and realistic and that the legislation, if enacted, would cost the chemical
industry between $100 to $200 million a year.

It is important to note that in the testing and key regulatory provi-
sions of the legislation, it is specifically required that the Admin-
istrator evaluate the risks and the benefits of his actions before taking
regulatory action. Thus, costs are not to be incurred unless they are otf-
set by benefits of at least the same magnitude. In comparing risks,
costs, and benefits, however, it is important to recognize that one is
weighing noncommensurates, and it is not feasible to reach a decision
just on the basis of quantitative comparisons. The burdens of human
suffering and premature death are extraordinary and must be given
full consideration in such decisions.

Legislative Background

S. 3149 had its genesis in the 92d Congress. On February 10, 1970,
the Administrator of tlie Environmental Protection Agency trans-
mitted by executive message a legislative proposal which was intro-
duced bv Senators Hart and Magnuson, by request, as S. 1478, the
"Toxic Substances Control Act of 1971."

Eight days of hearings were held in the 92d Congress on S. 1478
and amendment No. 338 wliich proposed major changes in the legis-
lation. The Senate passed the bill on May 30, 1972, following Com-
mittee action. The House of Kep resent atives acted late in the session
but there was insufficient time to reconcile the differences between
the Senate and House bills.

In the 93d Congress, S. 426 was introduced on January 18, 1973 by
Senators Magnuson, Tunney, and Hart. Three days of hearings were
held on S. 426 and S. 888, the Administration's bill. •

79-313 0 - 77 - 12

170

Following Committee action, the Senate passed S. 426 on July 18,
1973. The House of Eepresentatives passed S. 426 with amendments
in lieu of H.R. 5356 on July 23, 1973. However, as in the 92d Con-
gress, the conference was unable to rosolv^e the differences between the
House and Senate bills.

In the 94th Congress, S. 776 was introduced on February 20, 1975,
by Senators Tunney, Hart, and Magnuson. Hearings w^ere held on
March 3, 5, 10, April 5, and October 24, 1975.

The Subcommittee on Consumer Protection and Finance of the In-
terstate and Foreign Commerce Committee of the House of Repre-
sentatives reported H.R. 10318 on December 3, 1975. The Senate Com-
mittee on Commerce met in executive session on February 3, 4, and 17,
1976, to consider a substitute text offered by Senators Hartke, Tunney,
and Hart which conforms quite closely to H.R. 10318. The Committee
unanimously ordered the substitute text reported favorably with
amendments as an original bill, S. 3149.

Section-by- Section Analysis

section 1 short title and table of contents

The short title of the proposed Act is the ''Toxic Substances Control
Act." A table of contents is provided.

SECTION 2 — FINDINGS, POLICY, AND INTENT

Subsection (a) puts forth congressional findings that humans and
the environment are exposed to a large number of chemical substances
and mixtures and that some may cause an unreasonable risk of in-
jury to^ health or the environment. The findings also state that the
regulation of chemical substances and mixtures in intrastate commerce
is necessary to the effective regulation of interstate commerce in such
substances and mixtures.

Subsection (b) sets forth the policy of the United States that ade-
quate data should be developed with respect to chemicals and mixtures
and that manufacturers should have the responsibility of developing
the data. The subsection furtlier states that adequate authority should
exist to appropriately regulate subsances and mixtures and that
authority should not impede or unduly create unnecessary economic
barriers to technological innovation.

Importantly, subsection (c) states that it is the intent of Congress
that the Administrator "shall carry out this Act in a reasonable and
prudent manner, and that the Administrator shall consider the environ-
mental, economic, and social impact of any action the Administrator
proposes to take under this Act." While this section of the bill is not
an operative section, the intent of Congress as stated in this subsection
should guide each action the Administrator takes under othej* sec-
tions of the bill.

SECTION 3 — DEFINITIONS AND EXCLUSIONS

Subsection (a) sets forth the definitions which are used in the bill.

Of particular importance is the definition of a "chemical substance."
The term means any substance of a particular molecular identity in-
cluding a combination of substances occurring as a result of a chemical
reaction, or any element or uncombined radical.

171

The term does not include any mixture, ^rhich is a combination of
chemical substances which do not react chemically with each other and
the combination is not the result of a chemical reaction, or combina-
tion of chemicals occurrinof in nature. Mixtures may be addressed under
the provisions of the Act. but is excluded from the definition of chem-
ical substance so that automatic premarket notification does not take
place under section 5. As the term ^'mixture'' includes "articles con-
taining chemical substances'', the use of the latter term has been
deleted throughout the bill.

In addition, the term does not include pesticides, tobacco, or tobacco
products, nuclear material (as defined in the Atomic Energ\" Act),
firearms and ammunition (to the extent subject to taxes imposecl under
section 4181 of the Internal Tvevenue Code), or food, drugs, cosmetics,
or medical devices (as defined in the Federal Food, Drug, and Cos-
metic Act). The term food also means food as defined in the Poultry
Products Inspection Act, the Federal Meat Inspection Act, and the
Egg Products Inspection Act. With respect to the explicit exclusion
of nuclear materials, nothing in the bill should be construed as an im-
plicit exclusion of such materials from related Acts which contain no
cxplirit exclusion, such as the Federal Water Pollution Control Act.

Subsection (b) authorizes the Administrator to exclude from cover-
age under this Act or any provision of the Act, any substance or mix-
ture if the Administrator determines, by rule, that an unreasonable
risk of injury to health or the environment is not presented. The exclu-
sion under this subsection would not apply to the imminent hazards
authority of section 7 or the mandatory reporting of unreasonable
risk information under section 8(e) . Rules under this subsection are to
be promulgated in accordance with the rulemakin^r provisions of sec-
tion 6(c) which are similar to the rulemaking provisions of the Mag-
nuson-^f OSS Warranty Federal Trade Commi^^sion Act (89 Stat. 2183).

Exclusions under this subsection must be carefully drawn so that
unreasonable rislvs associated with the chemical substance or mixture
which ma}^ occur subsequent to the time of the exclusion are avoided
as well as risks known at the time of the exclusion. The situation must
be avoided where i^icw unpredictable uses, for example, of a chemical
substance, may not be properly controlled under the provisions of
this Act because of the existence of an exclusion under this subsection.

SECTION 4 — TESTING OF CHE^riCAL SnBSTANCES AND IMIXTURES

Subsection (a) sets forth the conditions under which the Adminis-
trator must require testinor of a chemical substance or mixture.

First, if a chemical substance or mixture (a) may present an un-
reasonable risk of injury to health or the environment, (b) there are
insufficient data or experience to reasonably determine or predict the
effects, and (c) testing is necessary to develop data, then the Adminis-
trator must require testing.

Second, if a chemical substance or mixture may present a signif-
icant human or environmental exposure because of production in sub-
stantial quantities or for other reasons, and the substance or mixture
may perhaps present an adverse effect on health and the environment,
the Administrator must require testing if the two other criteria ( (b)
and (c) above) are also satisfied. If there is no reliable data or experi-
ence available to the Administrator, the finding required with respect

172

to presentation of an adverse effect on health or the environment shall
be presumed.

With respect to mixtures, an additional finding must be made that
testing of components of the mixture is not a more reasonable and ef-
ficient means of determining the effects on health and the environment.

In requiring testing, the Administrator is to consider the reason-
ably ascertainable costs and other burdens associated with conducting
te^ts in light of the possible risk of injury to health or the environment
and shall publish this information in the Federal Register.

Of course, any judicial review of these considerations shall take
place at the time the final rule is reviewed in accodance with section
19. Thei* will be no separate review of these considerations as a pro-
cedural matter separate and apart from the review of the final rule.

Subsection (b) sets forth the requirements with respect to the con-
tent of the testing rule under subsection (a). An illustrative list of the
kinds of health and environmental effects for which testing may be
required is provided.

Tlie Administrator is required, at intervals of not less than 12
months, to review the adequacy of the rules developed under subsection
(a) and to make appropriate revisions, if necessary.

Eules developed under subsection (a) shall be promulgated in ac-
cordance with the informal rulemaking procedures of section 553 of
title 5, United States Code. The Administrator is required to give
interested persons an opportunity for the oral presentation of data,
views, or argument and to make a transcript of the oral presentation.
Any such oral presentation will be informal and not subject to many
of the delays associated with more formal hearings.

Subsection (c) provides an exemption from the testing requirements
so that the submission of duplicative data may be avoided. If an
exemption takes place, a cost sharing procedure is provided so that the
person granted the exemption provides fair and equitable reimburse-
ment to the person who develops the data. So that small businessmen
do not get assessed an undue proportion of the costs, the subsection re-
quires that among the relevant factors to be considered by the Admin-
istrator in determining fair and equitable reimbursement, that he con-
sider the effect on competition within the chemical industry and the
sliare of the market for such substance or mixture of the person re-
quired to provide i^eimbursement. Any exemptions provided under
this subsection, or under section 5(g), are expected to be made avail-
able to the public in accordance with the confidentiality provisions of
section 14 without delay. The most appropriate way would be to pub-
lish notice of the exemption in the Federal Register.

The reimbursement period lasts from 2 years after the date of sub-
mission or at the expiration of the period which the Administrator
determined was necessary to develop the data, whichever is later.

Provision is also made for the sharing of data cost which is in the
process of being developed.

Subsection (d) requires that the Administrator publish information
received in response to a testing requirement and make the data avail-
able to the public (in accordance with the Freedom of Information
Act provisions of section 14) , within 15 days of receipt.

Subsection (e) establishes a Federal agency advisory committee to
advise the Administrator with respect to testing priorities. Eight

173

members are provided including members from tlie Department of
Commerce, EPA, the Department of Labor, Council on Environmen-
tal Quality, the National Institute for Occupational Safety and Health,
the National Institute of Environmental Health Sciences, the Na-
tional Cancer Institute, and the National Science Foundation. The
members of the advisory committee are those Federal officials who
either have regulatory responsibilities in the area of chemical sub-
stances or mixtures, or have expertise with respect to testing needs. In
accordance with this principle, it is anticipated that the member from
the Department of Commerce would represent the National Oceanic
and Atmospheiic Agenc3\ or the National Bureau of Standards, or
some other agency within the Department of Commerce which has ex-
pertise with respect to testing needs.

Within 12 months after tlie inclusion of a chemical on the list, the
Administrator sliall either initiate a rulemaking under subsection (a)
or publish reasons for not initiating the proceeding. It is expected that
the Administrator's statement in tlie Federal Register will be specific
and will explain in some detail why the conditions for testing under
subsection (a) are absent.

Subsection (f) specifies required actions of the Administrator in
response to test data or other infoiTnation which indicates that a sub-
stance or mixture has the potential to induce: (1) cancer; (2) gene
mutations: or (8) birth defects. The Administrator must take appro-
priate action under the regulatory provisions of section 5(e), 6(a). or
7 within 180 days after the date of receipt of such data or information
or publish in the Federal Register his finding that no unreasonable risk
of injury is presented and his reasons for making such a finding. He is
only required to take this action when the substance or mixture has a
potential to induce these health effects at levels for which human ex-
posure exists, or will exist, with appropriate safety margins.

So that the Administrator may gear up for making these kinds of
determinations following the date of enactment, he is not required to
take action, or publish his reasons for failing to take action, until 2
years after the date of enactment of the Act.

SECTTOX 5 PREMARKET XOTIFICATIOX OF CHEMICAL SUBSTAXCES

Subsection (a) requires that manufacturers of new chemical sub-
stances give notice to the Administrator at least 90 days prior to the
first manufacture of a new chemical substance. The notification is
to be accompanied by all of the pertinent information referred to
in section 8(a) (2) regardless of whether he has or has not otherwise
required its submission under that section. Included would be the
identity of the chemical substance, uses anticipated, amounts to be pro-
duced, amounts anticipated for each category of proposed use, by-
products, lists of existing data concerning environmental or health
effex^ts, and estimates of the number of persons who will be exposed to
the substance in their places of employment. If unreasonable risks are
not presented, the Administrator is authorized to shorten the 90-day
mandatory notification requirement.

In addition, if the chemical substance is covered by a testing re-
quirement under section 4(a), the manufacturer is also required to
submit the data developed in accordance with that requirement.

174

Subsection (c) requires that tlie information submitted be published
in the Federal Register within 15 days of receipt, subject to the pro-
visions relating to confidentiality under section 14. The 90-day pre-
market notification period would begin upon publication in the
Federal Register.

Subsection (d) authorizes the Administrator to extend the initial
90-day period for an additional 90 days for good cause shown. Wliile
the majority of chemicals may be adequately screened during the ini-
tial 90-day period, there are instances in which an additional 90 days
may be necessary to adequately screen the substances. If a completely
new substance is being examined, for example, more time to adequately
review the information and take appropriate action would be neces-
sary. Thus, if the Administrator has not had sufficient opportunity
to review the premarket notification information, and to make a judg-
ment as to whether further action is necessary, he would have the
authority to postpone the manufacture of the substance for up to an
additional 90 days.

Subsection (e) authorizes the Administrator to issue orders during
the premarket notification period.

If the Administrator finds that a section 4(a) testing requirement
should be established (or should be added to or revised) he is required
to issue an order prohibiting or restricting the chemical substance
pending the completion of a rulemaking proceeding under section 4(a)
and the submission of any data required thereunder. The order is to be
immediately effective and shall contain a proposed rule (or amend-
ment or revision thereof) under section 4(a).

If the Administrator finds during the premarket notification period
that a rule is appropriate under section 6(a), he shall issue an order
which appropriately prescribes requirements authorized under sec-
tion 6(a). The order is to be immediately effective and must contain
a proposed rule under section 6(a).

The Administrator is directed to conclude the rulemaking proce-
dures under section 4(a) or section 6(a) as expeditiously as practi-
cable. If the oral presentation of data, views, or arguments, is
requested under section 4(a) or the opportunity to make written sub-
missions has been requested, the Administrator must begin this pro-
cedure within 30 days after such request. The same is true with respect
to a rulemaking under section 6(a) . If an informal hearing under that
section is requested, the Administrator must comply within 30 days.
In either case, the Administrator must affirm, modify, or revoke the
order issued within 10 days after the conclusion of the submissions or
oral presentation under section 4 or an informal hearing under sec-
tion 6.

Subsection (f ) requires the Administrator to publish in the Federal
Register his reasons if he decides not to issue an order under subsec-
tion (e) or to take action under the imminent hazards authority of
section 7 during the premarket notification period. The Administra-
tor's failure to issue such an order or take action under section 7 is
judicially reviewable in accordance with section 19. It is anticipated
that the Administrator's statement in the Federal Register will be
specific and contain sufficient information explaining why there are
no unreasonable risks which should have been protected against or a
need for more test data.

175

Subsection (<r) provides exemptions to avoid the submission of du-
plicative data which is similar to the jDrocedure described under sec-
tion 4(c) , described above.

Subsection (h) also provides for premarket notification procedures
with respect to significant new uses of existing chem.ical substances.
If a new use of an existing substance has been specified by the Admin-
istrator in accordance with this subsection, all of the premarket noti-
fication procedures and authority during the premarket notification
period apply to such new use of an existing substance.

Subsection (i) creates special exemptions which authorize the Ad-
ministrator to exempt from the premarket notification provisions per-
sons who wish to engage in test marketing or specially limited purposes
for chemical substances upon a showing that no unreasonable risks of
injuiy to human health or the environment would result. Appropriate
restrictions may be imposed by the Administrator.

In addition, premarket notification for those new chemical sub-
stances formed through intermediate reactions within reaction vessels
or in other instances in which there is no exposure to human beings oi;
the environment may be avoided through exemptions issued by the
Administrator.

Subsection (j) authorizes the Administrator to specify any mixture
which may be subject to any provision of the premarket notification
procedures.

There are mixtures such as. adhesives, paints and inks, which can
produce chemical substances upon end use. Chemical substances pro-
duced upon end use of such mixtures should not be considered new
chemical substances automatically subject to the premarket notification
provisions of this section. Manufacture is defined under section 3(a)
(7) to mean to "import, produce, or manufacture for commercial pur-
poses." These types of substances would not be covered under the pre-
market notification provisions because they are not manufactured for
commercial purpose, per se. Similarly, minor reactions occurring in-
cidential to the mixing process or upon storage of a mixture, such as
the cross-linking of polymers, would not constitute a basis for subject-
ing such mixtures to the premarket notification provisions intended
for new chemical substances because the resulting substances are not
manufactured for commercial purpose.

Such chemical substances arising during the formulation, storage
or use of such mixture should be considered as byproducts of the
precursor substance or substances. The responsibility for reporting
and testing such byproducts under the provisions of this legislation
would then fall upon the manufacturer of the precursor substance.
Of course, the Administrator may specifically subject any mixture
to the premarket notification provisions.

Subsection (k) specifically exempts from the premarket notification
provisions chemical substances which are manufactured or intended
to be manufactured in small quantities solely for scientific experimen-
tation or analysis or for chemical research. The Administrator is au-
thorized to include those kinds of chemical substances when they may
result in an unreasonable risk of injury to human health or the environ-
ment.

176

SECTION 6 — REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND

MIXTURES

Subsection (a) requires the Administrator to issue rules to protect
against chemical substances or mixtures which present or are likely to
present an unreasonable risk of injury to health or the environment. A
number of remedies are available to the Administrator ranging from
outrio^ht prohibitions to labeling requirements. A procedure is pro-
vided whereby production, processing, and distribution quotas may be
developed in those instances where a rule of the Administrator specifies
a total amount that may be produced, processed, or distributed and
for Federal supervision of any voluntary agreements that might be en-
tered into by persons who are the object of these rules and for adequate
protection against anticompetitive practices.

The authority of section 6(a) is broad enough to authorize the
control of those chemical substances or mixtures which may not be the
sole cause of an unreasonable risk. For example, if a number of prod-
ucts are responsible for an unreasonable risk, the Administrator
would be authorized to move against all of them even though no single
one of them can be shown to be the sole cause. The authority is also
broad enough to reach those chemical substances which may enhance
the toxic properties of other substances or mixtures through the proc-
esses known as synergism or potentiation.

Subsection (b) authorizes the Administrator to define the manner in
which a substance may be manufactured or proceessed if he has good
cause to believe that such manufacturing or proceessing causes the
adulteration of a chemical substance. A substance is considered adul-
terated if it contains another molecular identity, uncombined radical
element, or any combination thereof which, through the manner in
which it is manufactured or processed, causes or contributes to an
unreasonable risk of injury to human health or the environment. Rules
of this type would be developed in accordance with section 554 of title 5,
United States Code.

Subsection (c) requires the Administrator to consider the relevant
factors when issuing rules under subsection (a) and to make find-
ings with respect to them. Included are the risks presented to hu-
mans and the environment, the benefits of the substance or mixture,
and the reasonably ascertainable economic consequences of the rule,
including the consideration of the effect on the national economy, in-
novation, and public health. As is the case in other instances under the
legislation where the costs to the chemical industry of a rule are to be
considered, it is expected that the chemical industry w^ill come forward
with data bearing on the actual costs of compliance.

Findings required to be made shall be published in the Federal
Register. As is the case with respect to section 4(a) rules, and other
rules issued under the bill, findings of this type are not to be judicially
reviewed as a matter sepai'ate and apart from the final mile. Thus, the
findings published in the Federal Register are informational and will
not become the object of a separate judicial review.

This subsection also specifies the rulemaking procedures which are
to be followed in promulgating subsection (a) rules. The rulemaking
procedures are to be informal and in accordance with section 553 of
title 5, United States Code. Interested persons are entitled to orally
present their position and to present documentary submissions. In

177

addition, if the Administrator determines that there are disputed issues
of material fact, he must provide interested persons with the oppor-
tunity to make i-ebuttal submissions and to conduct such cross-exam-
ination as he determines to be appropriate and required for a full and
true disclosure with respect to the issues. Appropriate procedures for
limiting the extent of cross-examination are provided.

The Administrator is authorized to provide compensation for rea-
sonable attorneys fees, expert witness fees, and other costs of par-
ticipating in rulemaking proceedings to those persons who would not
otherwise be adequately represented in such proceedings if representa-
tion of these interests are necessary for a fair determination or such
persons are unable to effectively participate in the proceeding because
such persons cannot afford to pay the cost of paiticipating. Thus, the
provision Avill help insure that the interest of consumers, public inter-
est organizations, and otliers are represented by tlie rulemaking pro-
cedures of tliis section. Xo more than $1 million per year may be paid
under the provisions of this section.

The rulemaking procedures of this subsection are virtually identi-
cal to those contained in the Magnuson-Moss Warranty Federal Trade
Connnission xVct.

Subsection (b) requires the Administrator to specify in a rule is-
sued under subsection (a) the date on which it shall take effect, which
date shall be as soon as feasible. The relevant provisions of the Ad-
ministrative Procedures Act are preserved which authorize the Admin-
istrator to waive certain notice and procedural requirements when
these requirements are impracticable, unnecessary, or contrary to the
public interest.

SECTION 7 — IMMINENT HAZARDS

Subsection (a) defines an imminent hazard to be a situation involv-
ing an unreasonable risk of death, serious illness or serious personal
injury, or serious environmental harm which will occur prior to the
completion of an administrative hearing or other proceedings author-
ized under any other section of this bill.

Subsection (b) authorizes the district courts to take action against
imminently hazardous chemical substances, mixtures, or articles con-
taining the substance or mixture or against persons who manufacture,
process, distribute in commerce, use, or dispose of these subtances,
mixtures, or articles, or to take action against both the substance, mix-
ture, or article and any such person.

Subsection (c) authorizes the courts to grant such relief as may be
necessar3\ The subsection includes a number of illustrative examples.

Subsection (d) contains venue and consolidation provisions with
respect to suits brought under this section.

Subsection (e) requires the Administrator, where appropriate, to
initiate a rulemaking under section 6(a).

Subsection (f) authorizes the representation of the Administrator
.by attorneys of the Environmental Protection Agency w^th respect to
suits brought under this section.

SECTION 8 REPORTINQ AND RETENTION OF INFORMATION

Subsection (a) requires the Administrator to issue rules which re-
quire each person who manufactures or processes, or proposes to man-
ufacture or process, a chemical substance to maintain those records

178

and to make such reports as the Administrator may reasonably re-
quire. In addition, the Administrator is required to promulgate rules
which require manufacturers or processors of mixtures or chemical
substances produced in small quantities solely for scientific experi-
mentation or analysis, or for chemical research or analysis, to main-
tain records and to submit to the Administrator reports only to the
extent that it is necessary for the effective enforcement of the legis-
lation.

This subsection also contains an illustrative list of the kind of infor-
mation which the Administrator may require of manufacturers or
processors of chemical substances. Included are the identity of sub-
stances, categories or proposed categories of use, estimates of the
amount to be produced, and estimates of the amount which will be pro-
duced for each of its categories or proposals of use, a description of by-
products, all existing data concerning the environmental and health
effects of the substance or mixture, and estimates of the number of
workers who will be exposed to the chemical substance.

To determine which substances are new chemical substances for the
purpose of the premarket notification provisions of section 5, sub-
section (b) requires the Administrator to publish an inventory of
existing chemical substances not later than 270 days after the date of
enactment of the Act. Substances not appearing on that inventory
will be considered new chemical substances for the purposes of sec-
tion 5. Of course, any information the Administrator receives under
subsection (a) with respect to chemicals proposed to be manufactured
shall not be included in the inventory until premarket notification
occurs.

Subsection (c) requires persons who manufacture, process, or dis-
tribute in commerce chemical substances, or those intending to en-
gage in these activities, to maintain records of adverse reactions to
health or the environment alleged to have been caused by the substance
or mixture. These kinds of records shall be maintained for 5 years from
the date the information was reported to the person, except that re-
ports dealing with occupational reactions shall be retained for 30
years.

Subsection (d) requires persons who manufacture, process, or dis-
tribute in commerce chemical substances or mixtures to maintain lists
of health and safety studies conducted by them or for them with the
Administrator. The Administrator is authorized to require the sub-
mission of any study appearing on the list. The Administrator is au-
thorized to exclude certain types of categories of studies if they are
unnecessary to carry out the purposes of the Act.

Subsection (e) requires persons who manufacture, process, or dis-
tribute chemical substances or mixtures in commerce, and liabilit}^
insurers thereof, to inform the Administrator when they receive in-
formation which su Imports the conclusion that imreasonalole risks or in-
jurys to health or the environment are caused or contributed to by a
substance or mixture.

The Committee is concerned that any al1of\-atior!S of risVs or othor
information presented to the Administrator bv employees of the chein-
ical industry receive pro]ier attention by EPA. The situation that
existed with respect to the Kepone plant at Hopevvell, Va., whereby
an employee complaint to the Department of Labor allegedly was
insufficiently attended to, should not occur. EPA should respond prop-

179

erly to complaints received in the context of this authority, and the
Comptroller General may be asked by the committee to oversee EPA's-
procedures with respect to employee complaints.

SECTION 9 — RELATIONSHIP TO OTHER LAWS

This section is intended to minimize overlap and duplication be-
tween this act and other Federal laws while assuring protection from
environmental and health dangers.

Subsection (a) deals with the action the Administrator is to take
when he determines that a law administered by another agency could
be used to prevent or sufficiently reduce an unreasonable risk to health
or the environment presented bv a chemical substance or mixture. In
such a case the Administrator is to request that agency to (1) issue
an order declaring whether or not such a risk is presented, and (2)
if an order is isf?ued declaring that an unreasonable risk is presented,
to determine if tlie risk may be prevented or sufficiently reduced under
the law administered by that agency. The acrency is to respond to a
request from the Administrator within 90 days and publish its findings
and conclusions in the Federal Register.

The Administrator may not take action under sections 6 or 7 of this
act if the agency to which the request was addressed either issues an
order declaring tliore is no unreasonable risk or initiates action under
the law which it administers within 90 days of the publication of its
report.

Subsection (b) directs the Administrator to use the authorities under
other laws he administers to prevent or reduce risks to health or the
environment pre<^nted by chemical substances or mixtures unless he
determines that such risks may more appropriately be protected against
under this act.

Subsection (c) specifies that the exercise of authority by the Admin-
istrator under this act shall not constitute any limitation upon the
authority of the Occupational Safety and Health Administration to
prescribe or enforce standards or regulations affecting occupational
safety and health.

Subsection (d) directs the Administrator to consult and coordinate
his activities under this act with the Secretary of Health, Education,
and Welfare and the heads of other appropriate Federal agencies in
order to achieve maximum enforcement of this act while imposing the
least burden of duplicative requirements on those subject to the act.
The Administrator is to report annually to the Congress on these
efforts.

Subsection (e) specifies that nothing in this section shall limit any
requirement of section 4, 5 (other than sec. 5(e) ), or 8, or rules pro-
mulgated thereunder.

SECTION 10 RESEARCH, COLLECTION, DISSEMINATION, AND UTILIZATION

OF DATA

Siibsecfion (r>.) directs the Administrator to conduct research and
monitoring as is necessary to carry out the purposes of the act in
consultation and cooperation with the Secretary of Health, Education,
and Welfare and with other heads of appropriate Federal agencies.

Subsection (b) directs the Administrator to establish and administer

180

an interagency committee to (1) construct within the Environmental
Protection Agency an efficient system for the collection, dissemination
to other Federal agencies, and use of data submitted to the Administra-
tor under this act, and (2) coordinate the regulation of chemical sub-
stances among Federal agencies. In consultation with the Secretary
of Health, Education, and Welfare and the heads of appropriate agen-
cies, the Administrator is to design, establish and coordinate a system
for the retrieval of toxicological and other scientific data useiPul to
the Administrator in carrying out this Act.

Subsection (c) authorizes the Administrator, in consultation with
the Secretary of Health, Education, and Welfare, to make grants and
enter into contracts to carry out his responsibilities under this section.

SECTION 11 — ^IXSPECTIOXS AND SUBPOENAS

Subsection (a) authorizes the Administrator or his designee to in-
spect any establishment or facility in which chemical substances or
mixtures are m.anufactured, processed, or stored, or any conveyance
used to transport chemical substances or mixtures for their distribu-
tion in commerce. Such inspections shall require the presentation of
appropriate credentials and a written notice to the owner or agent in
charge of the premises or conveyance to be inspected, and shall be
conducted in a reasonable manner. An inspection shall extend to all
things within the premises or conveyance inspected (including records,
files, papers, processes, controls, and facilities) bearing on whether
the requirements of this act that are applicable to the chemical sub-
stances or mixtures within such premises or conveyance have been
complied with.

Subsection (b) authorizes the Administrator to require, by sub-
poena, the attendance and testimony of witnesses and the production
of reports, papers, documents, answers to questions, or other informa-
tion the Administrator deems advisable. In the event of controversy,
failure, or refusal of any person to obey such order, any district court
of the United States in which venue is proper shall have jurisdiction
to order any such person to comply tlierewith. Failure to obey an order
of the court is punishable by the court as a contempt.

SECTION 12 — EXPORTS

Subsection (a) exempts from the provisions of this Act (other than
sec. 8) any chemical substance, mixture or article containing a
chemical substance, mixture or article that (1) is manufactured, proc-
essed, sold, or held for sale solely for export from the United States,
and (2) is labeled so as to show that it is intended for export. This
exemption shall not apply to any substance, mixture or article that the
Administrator finds would cause or contribute to an unreasonable risk
to the health of persons within the United States or to the environ-
ment of the United States. This would provide control of substances
exported to Canada, for example, which may impact the Great Lakes
or substances to be disposed of by ocean dumping.

Subsection (b) requires that any person who exports or intends to
export a chemical substance or mixture shall notify the Administrator
of such exportation or intent to export if the chemical substance or
mixture is one (1) for which data is required under section 4 or 5,

181

(2) for whicli a rule has been proposed or promulgated under section
5 or 6, or (3) with respect to which an action is pending or relief has
been gi-anted under section 7. The Administrator shall furnish the
appropriate information pertaining to the application of this act to
the government of the foreign country for which the export is in-
tended.

SECnON 13 ^EXTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES

Subsection (a) requires the Secretary of the Treasury to refuse
entry into the customs territory of the United States of any chemical
substance, mixture, or article containing a chemical substance or mix-
ture offered for entry if (1) it fails to conform with any requirement
of this act or any rule in effect thereunder, or (2) it is otherwise pro-
hibited pursuant to this act from being distributed in commerte. The
subsection details the procedures the Secretary of the Treasury is to
follow in the event of an entry refusal.

Subsection (b) directs the Secretary of the Treasury, after con-
sultation with the Administrator, to issue rules for the enforcement of
subsection (a) of this section.

SECTION 14 — DISCLOSURE OF DATA

This section specifies that information obtained by the Adminis-
trator under this Act shall be subject to the Freedom of Information
Act wliich establishes the availability of information re-ceived by
Federal officials to the public. However, this section specifies that all
information received shall be disclosed (1) upon request, to offi-
cers_ or employees of the United States in connection with their
official duties under laws protecting human health or the environment
or for specific law enforcement purposes; (2) to contractors of the
United States when necessary in the perfomiancc of a contract; (3)
whenever the Administrator determines it necessary to protect human
health or the environment ; or (4) to any duly authorized committee
of the Congress upon written request. AMiile information is not re-
quired to be disclosed in proceedings under this Act in order to pre-
vent parties from joining such a proceeding just to get access to data,
the Administrator is expected to release information, as he may do
under the Freedom of Information Act, in proceedings when it will
be used for legitimate purposes in the proceeding.

SECTION 15 — rROlIIBITED ACTS

This section sets forth those acts that shall be unlawful under this
act. Such unlawful acts are (1) failure or refusal to comply with
any rule or order promulgated under section 4, 5, or 6 or any require-
ment prescribed by section 5, (2) the use or disposal of a chemical sub-
stance or mixture by such person who knew or had reason to know it
was manufactured, processed, or distributed in commerce in violation
of section 5 or a rule or order under section 6, (3) failure or refusal to
maintain records, submit reports, notices, or other information, or
permit access to or copying of records as required by this act or a rule
thereunder, or (4) failure or refusal to permit entry or inspection
as required by section 11.

182

SECTION 16 — PENALTIES

Subsection (a) provides civil penalties of up to $25,000 per day for
any person who violates this Act. Such civil penalty shall be assessed
by the Administrator after the opportunity for an adjudicative hear-
ing. In determining the amount of a civil penalty, the Administrator
shall take into account the nature, circumstances, extent, and gravity
of the violation as well as the violator's ability to pay, his ability to
continue to do business, his history of prior violations, and his degree
of culpability. The Administrator may compromise, modify, or remit
any civil penalty imposed under this subsection.

Any person who requests an adjudicative hearing for the assessment
of a civil penalty and is aggriev^ed by an order assessing a civil pen-
alty may file a petition for judicial review of such order with the U.S.
Court of Appeals for the District of Columbia Circuit or for any
other circuit in which such person resides or transacts business.

If any person fails to pay an assessment of a civil penalty after it
has become a final and unappealable order, the Attorney General is
directed to recover the amount assessed, plus interest, in any appro-
priate district court.

Subsection (b) provides criminal penalties of up to $25,000 per day,
in addition to or in lieu of a civil penalty, for any person who know-
ingly (having actual knowledge) or willfully violates this Act.

SECTION 17 SPECinC ENFORCEMENT AND SEIZURE

Subsection (a) grants the U.S. district courts jurisdiction over civil
actions sought by the Administrator or Attorney General, to restrain
violations of this Act, to compel actions required by this Act, or to re-
quire manufacturers or processors of chemical substances or mixtures
not in compliance Avith orders or rules issued under certain provisions
of this Act to give notice of such fact and to either repurchase or re-
place such substances or mixtures. Such a civil action may be brought
in the appropriate district court.

In the Committee's deliberations on the legislation, it was determined
that the language of amendment No. 21 (sponsored by Senators Philip
A. Hart, Xelson, and Percy) defining the burden a plaintiff must sus-
tain in order to gain relief under laws administered by EPA, or relief
sought by the Administrators, should not be incorporated in this
committee bill. The amendment attempted to rectify a three- judge
panel decision of the 8th circuit concerning relief sought against the
Reserve Mining Co. As decisions reached by the courts in subsequent
appeals are consistent with the requirements of amendment No. 21,
the amendment is unnecessary.

Subsection (b) makes any chemical substance or mixture manu-
factured, processed, or distributed in commerce in violation of this Act
•or any article containing such substance or mixture liable to seizure
and condemnation within the jurisdiction of any district court in which
i^ucli substance, mixture, or article is found.

SECTION 18 — PREEMPTION

Subsection (a) asserts that, except for certain specified limitations,
nothing in this Act shall affect any State's authority to regulate chem-

183

ical substances, mixtures, or any article containing such substances or
mixtures. The limitations are (1) if the Administrator has required
by rule the testing of a chemical substance or mixture under section 4,
no State or political subdivision may subsequently require testing for
purposes similar to those required under the rule, and (2) if the Ad-
ministrator prescribes a requirement under section 5 or 6 of this act
to protect against an unreasonable risk presented by a chemical sub-
stance, mixture, or article containing a chemical substance or mixture,
no State or political subdivision may subsequently regulate such sub-
stance, mixture, or article unless the regulation is identical to that pre-
scribed by the Administrator or unless the State or political subdivision
bans the use or distribution of such substance, mixture, or article within
the territorial jurisdiction of the State or political subdivision.

Subsection (b) specifies conditions under which the Administrator
may by rule exempt a State or subdivision from the limitations im-
posed in subsection (a). A State or subdivision may be exemp-ted if
their requirements would not cause a violation of tliis act, a signifi-
cantly higher degree of protection is afforded, and undue burdens on
interstate commerce would not result.

SECTION 19 — JTJDICL\L REVIEW

Subsection (a) specifies that not later than 60 days after the pro-
mulgation of any rule under this Act or an order under section 5(e),
any person may file a petition for judicial review of such rule. The
Administrator shall transmit to the Attorney General, who shall
file in the court, the record of the proceedings on which the Admin-
istrator based such rule or order as provided in section 2112 of title
28, United States Code. The term "record'' means such rule or order,
any transcript required of any oral presentation, any written sub-
mission of interested parties, and any other information the Admin-
istrator considers relevant and with respect to which the Admin-
istrator, on or before the date of promulgation of such rule or
order, published a notice in the Federal Register identifying such
information. Of course, the record need not contain written documen-
tation of each and every widely accepted scientific principle or fact
vrhich may support the rule or order issued. In these cases, it should
be presumed that agency expertise is definitive so that an extensive
record need not be developed or judicial review result with respect to
widely accepted scientific principle.

Subsection (b) authorizes petitioners to apply to the courts for
leave to adduce additional data, views, or arguments. If the petitioner
satisfies the court that such additional information would be mate-
rial and that there are reasonable grounds for the petitioner's failure
to adduce such information in the proceeding before the Adminis-
trator, the court may order the Administrator to provide additional
opportunity for oral presentation and written submissions. Upon
|the basis of the additional information, the Administrator may
modify the findings or determinations upon which the rule or order
reviewed by the court was based. Modified or new findings together
with the Administrator's recommendation, if any, for modifying or
setting aside such rule or order shall be filed with the court.

184

Subsection (c) grants the courts jurisdiction, upon the filing- of a
petition under subsection (a), (1) to review the rule or order in-
volved in accordance with chapter 7 of title 5, United States Code,
and (2) to grant appropriate relief, including interim relief, as pro-
vided in such chapter. This subsection explicitly states that any
iTile promulgated by the Administrator under section 5 or 6 and re-
viewed under this section shall be afiirmed unless the rule is not sup-
ported by the substantial evidence on the record taken as a whole.
Review of all other actions taken (or inaction) shall be on an "arbi-
trary or capricious" basis in accordance with chapter 7 of title 5,
United States Code.

Any considerations or findings required of the Administrator in
the process of developing a rule or order under this Act shall not be
reviewable apart from the review of the final rule or order.

Subsection (d) specifies that remedies provided in this section
shall be in addition to and not in lieu of any other remedies provided
by law.

SECTION 2 0 citizen's CIVIL ACTION

The provisions of this section are intended to provide a remedy
if the Administrator is lax in carrying out his duties under this Act.
Subsection (a) authorizes any person to commence a civil action
against persons alleged to be in violation of this act or any rule pre-
scribed under section 4 (testing), section 5 (premarket notifica-
tion), or section 6 (restrictive rules) to restrain such violation. In
addition, actions are authorized against the Administrator to compel
liim to perform any duty which is not discretionary under this Act.
Actions shall be brought in the appropriate district court.

Subsection (b) specifies certain limitations on the announcement
of a civil action. Xo action may be commenced before the expiration
of a specified time period after proper notice has been given of an
alleged violation or failure of the Administrator to perform a duty
under this act. Also, no action may be commenced if the Administrator,
or Attorney General on his behalf, has commxCnced and is diligently
prosecuting a civil action to require compliance with this Act.

Subsection (c) authorizes the Administrator to intervene in any
civil action under this section to which the Administrator is not a
party. The court is authorized to award costs of suit and reasonable
fees for attorneys and expert witnesses, if appropriate.

Nothing in this section shall restrict the right of any person under
any statute or common law to seek enforcement of this Act, or any
rule under this Act, or to seek any other relief.

Subsection (d) authorizes a court, upon application of the defend-
ant, to consolidate two or more civil actions brouglit under subsec-
tion (a) involving the same defendant and the same issues or viola-
tions when such actions are pending in two or more judicial districts.

SECTION 21 CrnZEN'S PETITIONS

This provision provides a means to initiate procedures for issuance
of a rule or order under this act to protect against unreasonable risk
of injury to healtli or tlie environment. Included, for example, would
be a testing requirement under section 4(a), a restrictive rule under

185

section 6(a) . or a modification of a section 3(b) rule which would have
the effect of further protecting against unreasonable risks by reducing
the extent to which a chemical substance or mixture is excluded from
coverage under the Act. Subsection (a) authorizes any person to peti-
tion the Administrator to issue such a rule or order.

Subsection (b) requires the Administrator to either grant or deny
a petition within 90 days after filing. If a petition is granted, the
Administrator shall promptly commence an appropriate proceeding
to comply with such petition. If a petition is denied, the Administrator
shall publish in the Federal Register the reasons for such denial.

If the Administrator denies a petition (or fails to act within the
90-day period), the petitioner may commence a civil action within 60
days, in a U.S. district court to compel the Administrator to initiate
the action requested. Because of the absence of an adequate record for
the court to review in such a case, the opportunity is granted to the pe-
titioner for a judicial review based on a preponderance of the evi-
dence in a de novo proceeding. If the petitioner can satisfy the court
by a preponderance of the evidence in such a proceeding that the ac-
tion requested in the petition conforms to the applicable requirements
of this act, the court shall order the Administrator to initiate the ac-
tion requested by the petitioner.

SECnOX 2 2 NATIOXAL DEFENSE WAFV ER

The Administrator is directed to waive compliance with any pro-
vision of this Act upon request of the Secretary of Defense and upon a
determination by the President that the requested waiver is necessary
in the interest of national defense.

SECTION 2 3 EMPLOYEE PROTECTION

Subsection (a) prohibits an employer from discharging or other-
wise discriminating against any employee because the employee, or
any person acting pursuant to a request of the employee, participates
or intends to participate in any way in any proceeding or action for
the purposes of carrying out the intent of this Act.

Any employee who believes that he or she has been discharged or
otherwise discriminated against is authorized by subsection (b) to file
a complaint with the Secretary of Labor within 30 days of the alleged
violation. The Secretary is to investigate such an alleged violation and
shall, within 90 days, issue an order either providing relief or denying
the complaint, unless the Secretary and the person alleged to have
committed such violation agree to a settlement. The forms of relief
which the Secretarv can provide are prescribed in this subsection.

Subsection (c) authorizes judicial review of an order issued under
subsection (b) upon petition by any person adversely affected or ag-
grieved by such order,

Whenever a person has failed to comply with an order issued under
subsection (b), subsection (d) directs the Secretary of Labor to file
a civil action in the appropriate district court to enforce such action.
In such civil actions the district courts shall have jurisdiction to grant
all appropriate relief, including injunctive relief and compensatory
and exemplary damages.

S. Kept. 94-698 5

186

Subsection (e) excludes from the protection of subsection (a) any
employee who, acting without direction from the employee's employer
or any agent of the employer, deliberately causes a violation of any
reauirement of this Act.

Subsection (f) directs the Administrator to conduct continuing
evaluations of the potential loss or shifts of employment which may
result from the issuance of any rule or order under this act. Any em-
ployee who is discharged or threatened with discharge or otherwise
discriminated against by any person because of the results of any rule
or order issued under this act may request the Administrator to
conduct a full investigation of the matter. The Administrator shall
thereupon investigate the matter, and, at the request of any interested
party, shall hold a public hearing. Upon receiving the report of any
such investigation, the Administrator shall make findings of fact as to
the effect of such rule or order on employment and shall make recom-
mendations as he deems appropriate, which report, findings, and rec-
ommendations shall be available to the public. Nothing in this subsec-
tion shall be construed to require the Administrator to modify or with-
draw any rule or order issued under this Act.

SECTION 24 — STUDIES

Subsection (a) directs the General Accounting Office to conduct a
study of all Federal laws for the purpose of determining whether and
under what conditions, if any, indemnification should be accorded any
person as a result of action taken by the Administrator under any
such law. The study shall include the probable cost and means of fi-
nancing any recommended indemnification and be submitted to the
Congress not less than 2 years from the date of enactment of this Act.

Subsection (b) directs the Council on Environmental Quality, in
consultation with the Administrator, the Secretary of Health, Edu-
cation, and Welfare, the Secretary of Commerce, and the heads of
other appropriate Federal agencies to coordinate a studj^ of the feasi-
bility of establishing (1) a standard classification for chemical sub-
stances, and (2) a standard means for storing and retrieving informa-
tion respecting such substances.

SECTION 2 5 ADMINISTRATION OF ACT

Federal agencies are authorized in subsection (a) to cooperate with
the Administrator by making their services, personnel, and facilities
available to assist in the administration of this act and by making
available to the Administrator information necessary for the admin-
istration of this Act.

Subsection (b) authorizes the Administrator to require, by rule, the
payment of a reasonable fee, not to exceed $2,500, from any person
required to submit data under section 4 or 5 to defray the cost of ad-
ministering the Act.

Subsection (c) authorizes the Administrator to take action with
respect to categories of chemical substances or mixtures as well as in-
dividual chemical substances or mixtures. For purposes of defining a
category, chemical substances or mixtures may be grouped by virtue
of similarities in their chemical structure, physical, chemical or bio-
logical properties, use, mode of entry into the human body or environ-

187

ment, or in some other way suitable for purposes of this Act. This
authority is given to the Administrator to facilitate the efficient and
effective administration of this act and is not to be used in any way
that would frustrate the intent of any provision of this Act. Thus,
for example, categories might be appropriately used for purposes of
compiling the inventory of section 8(b) so that every variation in
the distribution of a polymer chain length would not be automatically
subject to tlie premarket notification requirement. However, categories
are not to be used in the section 8(b) inventory so as to effectively
provide exemptions for new chemical substances intended to be
cOA'ered under the premarket notification provision.

Subsection (d) specifies that any proposed or final rule or order
issued xmder this Act shall be accompanied by a statement of purpose
and justification. This statement shall identify the sources and pre-
cise nature of the most important information used in deciding upon
the rule or order and shall indicate the weight or importance the Ad-
ministrator gave to the various elements of information in arriving
at his decision. Such a statement shall be considered part of the "rec-
ord of the proceedings" for purposes of judicial review under section
19(a).

Subsection (e) directs the President, by and with the advice and
consent of the Senate, to appoint as Assistant Administrator of the
Environmental Protection Agency an individual who by reason of
background and experience is especially qualified to direct a program
concerning the effects of chemicals on human health and the environ-
ment. Such Assistant Administrator shall be responsible for the effi-
cient collection and analysis of data necessary for making well-in-
formed regulatory decisions and the development of a spectrum of
regulatory options available to the Administrator.

SECTION 2 6 — AUTHORIZATION FOR APPROPRIATIONS

Subsection (a) authorizes to be appropriated to the Administrator
for carrving out this act $11 million for the fiscal year ending June 30,
197G; $2,600,000 for the transition quarter, July 1 to September 80,
1976 ; and $10 million for the fiscal year ending September 30, 1977.
No part of these funds are to be used for the construction of research
laboratories.

Subsection (b) requires that whenever any budget request, supple-
mental budget request, supplemental budget estimate, legislative
recommendation, prepared testimony for congressional hearings or
comments on legislation relating to this act is sent to the President or
to the Office of Management and Budget, the Administrator sliall
concurrently transmit a copy to the Congress. This subsection further
prohibits any officer or agency of the United States from requiring
the Administrator to submit this information to him prior to its sub-
mission to Congress. The provision is virtually identical to that con-
tained in the Consumer Product Safety Act.

SECTION 2 7 — ANNUAL REPORT

The Administrator is required to submit to the President and the
Congress a comprehensive annual report on the administration of this
Act. A list of items to be included in the report is presented.

188

Changes in Exestino Law

No changes in existing law are made by the bill as reported by the
Committee.

Estimated Costs

Pursuant to the requirements of section 252 of the Legislative Re-
organization Act of 1970, the Committee estimates the cost of the bill
for each of the first 5 fiscal years as follows :

Fiscal years : Amount

1976 $11,100,000

Transition quarter 2, 600, 000

1977 10,100,000

1978 11,000,000

1979 12,000,000

1980 13,000,000

The Committee knows of no cost estimates made by any Federal
agency which differs from those tabulated above. The estimates were
derived from information submitted by EPA.

Kecord Votes in Committee

1. On the motion by Senator Hartke to require that "reasonably
ascertainable economic consequences" of section 6(a) rates be con-
sidered, that findings be made with respect to all relevant factors
considered, and that such findings be published in the Federal Register.

TEAS (17)

Magnuson Tunney
Pastore Stevenson
Hartke Ford
Hart Pearson
Cannon Baker
Long Beall
Moss Weicker
Hollings Buckley
Inouye

NATS (1)

i Durkin
.2. On the motion of Senator Hartke to report the bill favorably:

jNIagnuson

Pastore

Hartke ■

Hart.

Cannon

Long

]\ross

Hollings

Tnouye

Tunney

TEAS (20)

Stevenson

Ford

Durkin

Pearson

Griffin

Baker

Stevens

Beall

Weicker

Buckley

NAYS (0)

189

Text of S. 3149, As Reported
*******

Agency Comments

Ex\TROXMENTAL PROTECTION AgENCY,

Office of the Administrator,
Washington, D.C., June 23, 1975.

Hon. "Warren G. Magnuson,
Chairman^ Committee o^i Commerce,
U.S. Senate,
Washington, D.C.

Dear Mr. Chairman : This is in response to your request of March 6,
1975, for the views of the Environmental Protection Agency on S. 776,
the Toxic Substances Control Act.

We are in accord with the objectives of S. 776 and the general
approach taken in the bill to control toxic substances. As we testified
before your Subcommittee on the Environment on March 10, 1975, the
bill contains the authorities which we believe are essential for effective
toxic substances control legislation. We urged the enactment of toxic
substances control legislation and indic^ated that we would have sug-
gestions on some of the specific provisions of S. 776 when we submitted
our report.

We note that S. 776 contains significant improvements over some of
the toxic substances control bills that have been before the committee
the past 4 years. Many of thcvse improvements are consistent with past
EPA recommendations. It is not our intention in our report by con-
centrating on suggested revisions to the bill to detract from or fail
to recognize the effort and improvements already eWdent in S. 776.

We liave already stated in our testimony our objection to the pro-
vision that would preclude tlie Administrator from forwarding any
budget estimates, legislative proposals, comments on legislation, or
testimony to the Office of ^lanagement and Budget prior to the trans-
mission of these same materials to the Congress. We also stated in our
testimony that to desigTiate by statute the specific responsibility of an
Assistant Administrator may tend to crexite a problem of internal
management.

We will discuss below a number of additional areas in S. 776 where
we have particular problems and where we believe amendments are
in order. These proposed amendments are set out in an attachment to

190

this letter along with a number of important additional amendments
and brief explanations of each. We urge that all of these amendments
be favorably considered by the committee.

This report on S. 776, including the attached proposed amendments
were jointly developed with the other concerned Federal departments
and agencies and represents the views of the administration on S. 776.

Policy of Administration

We are proposing that the Declaration of Policy section of the bill
include recognition of the role of this legislation in complementing and
supplementing a number of present Federal programs that deal with
various aspects of toxic substance control. We are also proposing that
the general requirement of the bill for consultation and coordination
make specific reference to this policy statement. Such amendments
would be of great assistance in the day to day administration of this
legislation, both by assuring due regard for the responsibilities of
other agencies, and by helping to establish the atmosphere of coopera-
tion and interchange which is vital to the successful operation of com-
prehensive toxic substances legislation.

In line with this policy, and because of the special role of the Occu-
pational Safety and Health Act of 1970 in providing workers with
protection from unsafe or unhealthful working conditions which may
be created through the manufacture, distribution or use of toxic sub-
stances, we are also proposing some language for the bill and some
language for the committee report to assure that there will be no
question about the respective regulatory jurisdictions of EPA and the
Department of Labor.

Definitions

We are proposing that the definition of "chemical substance" be
amended to provide the Administrator with some flexibilitv to exclude,
in appropriate situations, certain substances from the definitions and
thus from the requirements of the act or from particular provisions of
the act. It would be almost impossible to draft the bills to exempt
certain substances from the act or, as more likely the case, from certain
provisions of the act in each situation where such is necessary. Scien-
tific laboratory reagents are an example. Here it may very well be
appropriate to exclude such nroducts from the testing and regulatory
provisions, but not necessarily the reporting and adverse effects provi-
sions when they are used by certain research or scientific laboratories:
on the other hand, we would not likely wish to exclude high school
laboratories from any labeling requirements. An exclusion may also be
in order for a substance not manufactured in commercial quantities.
An excessive burden and inconvenience to the industry or the user
would be averted with this flexibility in the act.

We anticipate that the Administrator would exercise his discretion
to exclude from the definition of chemical substances most substances
manufactured in less than commercial quantities for the purpose of
testin.^. Thus, most substances manufactured in less than commercial
miantities would be exempt from the testing provisions of the bill.
The proposed amendment would however enable EPA to require
testing in those cases where the potential threat to health and the en-
vironment showed such testing to be necessan\

191

TVe are also proposing to add to the act a definition for a "new
chemical substance.'' This is necessary in order that chemical sub-
stances which were used in previous years for some purpose, and such
use discontinued, do not become classified as existing chemicals, and
thus exempt from certain requirements relating to new substances.

Testing

The testing provisions provide that standards for test protocols
would be promul crated, rather than the test protocol itself. Testing
would be required only for substances which the Administrator de-
termines may present an unreasonable risk to health or the environ-
ment, where there are insufficient data to conclude that such a risk
does or does not exist, and where testing would assist in making such a
determination.

There is a provision in the testing requirement of the bill that we
foresee as an undue burden upon the Administrator. While we agree
that provision should be made for the sharing of testing costs in the
event that there is more than one manufacturer of a substance for
which testing is required, we are very reluctant to become involved
in designating which manufacturer — or possibly a third party — should
conduct the tests if the parties cannot reach an agreement. We are
therefore recommending deletion of the provisions authorizing the
Administrator to designate which party should do the testing.

A further amendment we are proposing with regard to the testing
provisions is a specific requirement that the Administrator must con-
sider alternative methods for meeting the standards for test protocols
proposed by a manufacturer, such as one that might be less costly or
more effective. This would insure that industry is allowed to use the
best test protocols in meeting the testing standards.

Premarket screening

We are proposing an amendment which will delete the authority in
the bill to treat a rule proposed under section 6 during the premarket
review period of a product as a final rule. Thus a chemical substance
of product may be manufactured and distributed after the premarket
review period unless a restriction is obtained under the imminent
hazard provision of the act. The substance or product, however, re-
mains subject to all other provisions of the act and a rule proposing
restrictions on the substance or product may be proposed immediately
during the premarket review period under section 6 and the rule-
making proceedings initiated at that time.

If it appears that the manufacture, processing, or distribution of a
chemical substance or product will result in any unreasonable threat to
human health or the environment prior to the completion of the rule-
making proceedings, action may be taken to restrict or ban it under the
imminent hazard provisions of the bill, thus preventing it from be-
coming a threat to health or the environment.

Quotas

Another difficulty we have with S. 776 concerns the requirement that
the Administrator provide for the assignment of quotas in any regu-
lation limiting the amount of a substance which may be manufac-
tured, imported, or distributed. The mandatory requirement of a quota
system would make the regulatory process vastly more cumbersome
and difficult to administer. Thus, we recommend that the quota provi-

192

sion be deleted. The act already provides that when it is necessary to
adopt a rule with respect to a chemical substance to protect against an
unreasonable risk, the Administrator shall select the least stringent
requirement practicable, consistent with protection of health and the
environment. In our view, restrictions limiting the amount of a sub-
stance that may be manufactured would be the most stringent require-
ment, other than a total ban, and the establishment of quotas would
seldom be necessary. Nevertheless, we strongly recommend against be-
coming involved in the establishment of quotas for various manufac-
turers, even in such limited situations.

Economic impact

S. 776 would require that the Administrator consider a number of
relevant factors in promulgating iiilcs with respect to a chemical sub-
stance. We are proposing that a specific provision be added that he
also must consider the economic impact of such action, including, but
not limited to, consideration of the effects on business, employment,
and the national economy. Consideration of these factors are already
inherent in the requirement that he consider all relevant factors. This
amendment is submitted in lieu of other proposals that have already
been made for the mandatory preparation of detailed economic im-
pact statements at the time a regulation is promulgated.

Health and safety studies

We are proposing a revision of the requirement for the submis-
sion of health and safety studies, or lists of such studies, in order to
provide some flexibility in this requirement. This should lessen the
burden to industry in compiling the lists or submitting the studies,
and to EPA in not being overburdened with information it does not
need or cannot effectively use. The amendment would require submis-
sion of lists of ongoing and new studies, rather than the study, with
a right to require the submission of a given study. It would author-
ize the Administrator to provide by regulation the types of studies
to be included on the lists and the number of years for which prior
studies must be listed. The amendment would also provide that a per-
son would list studies which he knows are being made or have been
made.

Confidential information

We are recommending that the confidentiality provision, section 15
of S. 776, be amended in several respects. First, the substantive cri-
terion for withholding data as confidential should be the test estab-
lished by the Freedom of Information Act, 5 U.S.C. 552(b) (4). Our
proposed amendment would have the effect of requiring nondisclosure
of information obtained under the Toxic Substances Control Act
which may be withheld under 5 U.S.C. 552(b)(4)., that is, "trade
secrets and commercial or financial information obtained from a per-
son and priviliged or confidential." This will make the confidentiality
standard more definite (because there exists a body of case law inter-
preting 5 U.S.C. 552(b) (4)), and will promote uniformity.

193

plishes a great deal of its investigatory and analytical tasks by con-
tract. If contractors are not allowed access to information under this
bill, EPA could not perform its duties satisfactorily without substan-
tial manpower increases. The recently enacted Privacy Act, 5 U.S.C.
552a, provides that, for purposes of the section of the Privacy Act
which imposes penalties on Government employees for wrongful use
or disclosure of information entitled to confidentiality, Government
contractors and their employees are to be considered Government em-
ployees (5 U.S.C. 552a (m) ). We recommend inclusion of such a pro-
vision in the toxic substances bill. Our proposed amendments allow
disclosure to contractors, and include a penalty for wrongful disclos-
ure of information by Government employees (including contractors
and their employees) .

We also believe that the provisions relating to qualified scientists
and individual names are not necessary. The term "qualified scien-
tists" would be difficult to interpret, and in any event a scientist
would have no greater rights under the subsection than would any
person under our (proposed) basic confidentiality criterion. We be-
lieve that the Federal Privacy Act and the Freedom of Information
Act provide ample protection of the rights of individuals whose names
appear in health and safety records.

Finally, with regard to access of information by Congress, we be-
lieve that such confidential information should be made available upon
written request.

Exemption from Federal preemption

We do not rec(Hnmend the provisions of S. 776 which would allow
State and local agencies to petition the Administrator for exemption
from the Federal preemption requirements. State and local agencies
would be allowed to regulate any toxic substance until such time as
the Administrator puts into effect regulations for testing or restricting
a substance. Thereafter, they could impose only a total ban on a sub-
stance. In view of the fact that the bill authorizes the Administrator
to regulate with respect to geographic areas there would appear to be
no need for a State or local agency to duplicate any regulations with
respect to a substance after Federal regulations are in effect.

Interagency cooperation and coordination

Several amendments are being proposed to the act to provide for
the maximum cooperation and coordination among the several agen-
cies of the Federal Government which have programs and responsibil-
ities concerned with toxic substances. These amendments also would
clarify that the act is intended to complement and supplement exist-
ing laws and regulations such as the occupational health and safety
requirements.

A number of Federal agencies, particularly the Department of
Health, Education, and Welfare and the Occupational Health and
Safety Administration of the Department of Labor have extensive
responsibilities relating to toxic substances and human health and
would stand to benefit from various provisions of the act. For exam-
ple, test results and other data generated in this area would, of course,
be valuable to them and should be made available to all agencies
concerned.

194

We are also recommending that the provision contained in previous
bills before the Congress directing the Council on Environmental
Quality to coordinate a study on the feasibility of establishing a stand-
ard classification system for chemical compounds and means of ob-
taining rapid access to information on such substances be restored to
the act. This section provides CEQ the lead in establishing information
systems in a manner currently being initiated. This is being done in
conjunction with the agencies that would have been represented on the
interagencv committee as set out in the provision proposed to be de-
leted.

Appropriations

We wish to make clear that our budget requests over the past several
years have included funds to handle work anticipated to be required
under toxic substances legislation, in the expectation that it would by
now have been a reality. Consequently, considerable groundwork has
been laid and we anticipate that activities during fiscal year 1976 can
be met within the $8 million requested in the President's budget. Fur-
thermore, we would point out that EPA wishes to remain in accord
with the President's stated policy of holding new spending to an ab-
solute minimum. Consequently we would point out that the authori-
zation levels in S. 776 are in excess of amounts required to implement
its provisions.

We have outlined above in our letter a number of the proposed
amendments to the act which we consider important : the attachment
contains both these and additional amendments which we believe are
of equal importance. We stronglv believe that the adoption of these
amendments would improve and strengthen the legislation and en-
able EPA to protect the health and the environment to the greatest
practical extent while at the same time relieving the industry as well
as the Government of some burdensome requirements.

With the favorable consideration of these proposed amendments,
we would urge the enactment of S. 776.

My staff and I stand ready to assist your committee in any way
possible.

We are advised by the Office of Management and Budget that there
is no objection to the submission of this report from the standpoint of
the program of the President.
Sincerely yours,

John R. Quarles, Jr.,

Acting Administrator.

Toxic Substances Control Act

PROPOSED AMENDMENTS BY EPA AND OTHER FEDERAL AGENCIES TO S. 77«

1. Definitions

a. Page 4, lines 1 and 2, delete the language "or in some other way
suitable for formation of a group for the purposes of this Act".

Explamxition. — This amendment would delete the open-ended au-
thority to designate almost any grouping as a "category of chemical
substances".

195

b. Page 4, line 5, delete paragraph (3) and insert new paragraph

(3) "Chemical substance' means any chemical substance
which (A) has an organic or inorganic particular molecular
identity: (B) is any combined or uncombined radical or ele-
ment; or (C) is any mixture; Provided^ however, the Ad-
ministrator may by regulation exclude from this definition
as it applies to tliis Act, or to any provision of this Act, cer-
tain categories of chemical substances such as scientific labora-
tory reagents and samples, or chemical substances not manu-
factured in commercial quantities.

Explanation. — This amended definition of a "chemical substance"
would provide the Administrator with flexibility to exclude, in appro-
piiate cases, substances from the requirements of the Act, or a par-
ticular provision, where it does not need to be regulated, cannot be
effectively regidated, or where meeting the requirements might be an
undue burden. Scientific laboratory reagents, samples, and other chem-
ical substances manufactured in less than commercial quantities are
examples.

We urge the following language be included in the committee report
with respect to this definition :

Chemical substance v.ould be defined to permit the Ad-
ministrator the flexibility to provide by regulation for ex-
empting chemical substances in certain categories or in less
than connnercial quantities from certain provisions of the
bill. With respect to those chemical substances, it is antici-
pated that the Administrator will exercise his discretion to
exclude, and thereby exempt, most of them from the testing
provisions of the bill. The Administrator retains the author-
ity to require testing in those cases where he finds a potential
threat to health and the environment which indicates that
such testing is necessary.

c. Page 5, line- 2, delete the period and insert a semicolon after
^'studies'' and delete remainder of paragraph ; and on line 12, delete
"study-' and insert "study, including health and safety data developed
pursuant to such study,".

ExplanatloTi. — Correspondence relating to alleged adverse effects
on health and similar reports are already required to be maintained
in the section 8(d) regarding records, and an amendment is proposed
to authorize the Administrator to require submission of such records.
There is no need to include unconfirmed complaints and notices in
the definition of health and safety data and confusion results when
this is attempted. It is also proposed to specifically provide that a
health and safety "study" includes health and safety data develdped
pursuant to such study,".

d. Page 6, insert after line 14 the following and renumber other
paragraphs accordingly.

(15) "new chemical substance" means any chemical sub-
stance which has not been manufactured or imported in com-
mercial quantities into the United States during the 18-month

196

period immediately prior to the effective date of this Act,
regardless of its commercial production or importation in the
United States prior to such time.

Explanation. — -A definition of "new chemical substance" is neces-
sary in order that chemical substances that were used in prior years
and were discontinued do not become classified as existing cheniicals
for purposes of this Act.

2. Testing

a. Page 9, after line 8, insert new paragraph (4) as follows:

(4) The Administrator will consider alternative methods
for meeting the standards for test protocols proposed by any
person or governmental entity which is a manufacturer, proc-
essor, or importer of such chemical substance.

Explanation— This amendment would specifically direct the Ad-
ministrator to consider alternative methods for meeting the standards
for test protocols proposed by a manufacturer, such as less costly or
more effective test protocols.

b. Page 9, line 14, delete the last two sentences in paragraph (1)
beginning with "If", and insert in lieu thereof : "If such an arrange-
ment is made the Administrator shall be notified and the remaining
such persons shall be exempted from requirements to perform tests."

Explanation. — ^We do not believe that the Administrator should
become involved in designating which part}^ (or a third party) should
perform tests if the parties cannot agree among themselves. If a cost-
sharing arrangement is made for one of the parties to do the testing,
however, provision should be made to exempt the other parties from
the testing requirements.

c. Page 11, line 15, insert after "arguments," the following: "and
permit cross-examination to such extent and in such manner as in his
discretion he determines is necessary and appropriate in view of the
nature of the issue involved, the number of the participants and the
nature of the interests of such participants,".

Explanation. — This amendment would permit limited cross-exam-
ination as is provided in the section 6 rulemaking procedures to restrict
toxic chemicals.

3. Premarket screening; imminent hazard

a. Page 12, line 3, after "substance" add the following sentence:

Subsequent submission or request for submission of addi-
tional information shall not be regarded as changing the date \
of such notice.

Page 13, line 4, delete entire subsection (c) ; on line 25, delete be-
ginning with "Unless" through "90 days" on line 2, page 14, and
insert in lieu thereof "Ninety days" ; renumber following subsections
accordingly.

Page 14, line 10, after "substance" insert "before or".

Page 22, line 13, after "environment," insert "that should be cor-
rected immediately, and".

Explanation. — ^These amendments will delete the authority in the
bill to treat a rule proposed under section 6 during the premarket re-
view period of a product as a final rule.

197

Thus a chemical substance or procluct may be manufactured and
distributed after the premarket review period unless a restriction is
obtained under the imminent hazard provision of the Act The sub-
stance or product, however, remains subject to all other provisions of
the Act and a rule proposing restrictions on the substance or product
may be proposed immediately durin^: the premarket review period
under section 6 and the rule-making proceedings initiated at that
time.

If it appeal's that the manufacture, processing, or distribution of a
chemical substance or product will result in any unreasonable threat
to human health or the environment prior to tJie completion of the
rule-making proceedings, action may be taken to restrict or ban it
under the imminent hazard provisions of the bill, thus preventing it
from becoming a threat to health or the environment.

The other amendments would clarify the date premarket notice
commences, that restrictive rules under section 6 may be- promulgated
before or after manufacture or distribution of a substance, and that
an imminent hazard is a risk that should be corrected immediately.

4. Restnctions on hazardous chemical substances

a. Page 17, line 23, delete "condition" and insert in lieu thereof
"circumstances'*, and insert the following language in the committee
report with respect to section 6 of the bill :

The provisions of section 6 of S. 776 provide EPA with
regulatoiy authority which will complement and supplement
existing authority to control hazardous substances but not to
preempt authority already vested by statute in other Federal
departments or agencies. Proposed new section 9(b) would
preclude EPA from taking action under sections 6 and 7
which the Secretary of Labor could take imder the Occupa-
tional Safety and Health Act. Thus, for example, the Ad-
ministrator of EPA could not. under section 6(a) (3) require
that a substance be lal>eled so as to prescribe requirements for
its safe and healthful use which apply solely, to workers in
their place of employment. The Department of Labor, pur-
suant to the Occupational Safety and Health Act of 1970,
already has autliority to prescribe safe and healthful work-
ing conditions. Similarly, section 6(b)(2) shall not be con-
strued to allow tlie Administrator of EPA to establish occupa-
tional safety and health standards.

Explanation. — The clarification to paragraph 6(a)(2), together
with the addition of le^rislative history with respect to paragraphs
6(a) (3) and 6(b) (2), will assist in implementation of the bill's policy
to "complement and supplement" existin^r authority. These changes
will assist in avoidini? overlap between EPA and the Department of
Lalx)r*s workplace safety and health authority.

b. Page 18, line 17, paofe 20, line 23, paoe'21, lines 6 and 12, delete
"adulterated" (or "adulteration") and insert in lieu thereof "con-
taminated" (or "contamination").

Explanation. — We believe that the term "contaminated" (or "con-
tamination") would more clearly express the intent of these provisions
instead of "adulterated" which is often undei-stood or defined as an
intentional act.

198

c. Page 19, line 11 , delete entire para^ra ph ( 3 ) .

Explanation. — ^We believe that the Administrator should not be-
come involved in assigning quotas to industry. The mandatory re-
quirement of a quota system would make the regulatory process vastly
more cumbersome and difficult to administer. The Act already pro-
vides that when it is necessary to adoj^t a rule with respect to a chemi-
cal substance to protect against an unreasonable risk, the Administra-
tor shall select the least stringent requirement practicable consistent
with protection of the health and the environment. It is expected that
the establishment of quotas would seldom, if ever, be necessary as such
would be a most stringent requirement. Xevertlieless, we strongly rec-
ommend against becoming involved in the establishment of quotas..

d. Page 20, after line 15, insert the following :

(4) the economic impact of sucli action, including, but not
limited to, consideration of the effects on business, employ-
ment, and the national economy.

Expla/nation. This amendment would specifically require the Ad-
ministrator to consider economic impact in promulgating regulations,.
alreach'" inherent in the requirement that he consider all relevant fac-
tors. This would be in lieu of proposals that have been made for th&
mandatory preparation of detailed economic impact statements for
issuance at the time any regulation is promulgated.

5. Suits hy U.S. attorneys instead of hy Administrator'

Page 22, line 17, delete all after "may" thi ough "so,", line 19 and in-
sert in lieu thereof : "request a United States Attorney to petition an
appropriate district couit of the United States''
Page 39, line 3, delete "Administrator or the".

Page 46, line 7, delete "Administrator (or Attorney General on his
behalf) " and insert in lieu thereof "Attorney General".

Page 46, line 8, after "commenced" delete "and is diligently prose-
cuting" on lines 8 and 9.

Explanation. — These amendments would carrv out the long-time
policy of having the Justice Depaitment l esponsible fpr litigation in-
stead of. each Agency. In the citizen suit provisions, wc believe that it
is sufficient if the Attomev General has commenced an action and that
it is not necessary to impose a further requirement that he be diligent-
ly prosecuting it, a concept which is at best difficult to litigate and at
worst could lead to counter-productive court action.

(S. Sid)mi8siono_f records; health and safety studies

a. Page 25, line 3, add at end of sentence :

The* Administrator may require copies of such records pur-
suant to his responsibilities under sections 4, 5, 6, and 7 of this
Act.

Explanation. — Wiile the bill provides that records of adverse health
effects caused by chemical substances are required to be maintained,
no provision is made to require submission of such records. This
amendment would correct that omission.

b. Page 25, line 4, delete subsection (e) and insert in lieu thereof:

;(e) Health and Safety Studies. The Administrator shall
promulgate regiilations under which he may require any per-

199

8:i

son who manufactures, processes, or distributes in commerce
any chemical substance (or with respect to paragraph (3),
any person who has possession of a study) to submit to him—

(1) lists of health and safety studies in progress on or
initiated after the date of enactment of this Act, con-
ducted by or for such person, or known to such person;

(2) lists of health and safet}^ studies conducted by or
for such person, or known to have been made by any per-
son, prior to the date of enactment of this Act ;

(3) copies of any such studies appearing on a list sub-
mitted pui^suant to paragraphs (1) or (2), or otherwise
known by him.

Explanation, — Tliis amendment would revise the provision re-
quiring industry to report on or submit all health and safety studies.
It would requii e submission of lists of ongoing and new studies rather
than the study, with a right to require submission of studies. It would
authorize the Administrator to provide by regulation for the types of
studies to be included on the lists, and the number of years of prior
studies for particular types of studies; and would require a person to
also list studies which he knows are being made or have been made.

7. Additional exemptwn : additional limitation on authority

. a. Page 26, line 8, delete "or"; line 10, after '*Act)" insert a comma
and add "cosmetics (as such term is defined in section 201 (i) of the
Federal Food, Drug, and Cosmetic Act),''; line 18, replace the period
with a semicolon, and add the following :

(3) any source material, special nuclear material or by-
product material as defined in the Atomic Energy Act of
1954 (42 U.S.C. 2011), as amended, and regulations issued
pursuant thereto ; or

(4) tobacco and tobacco products.

Explanation, — We believe that cosmetics should also be exempted
and materials regulated under the AEC Act, and do not believe that
tobacco products.should be regidated under the Toxic Substances Con-
trol Act.

b. Page 26, after line 18, add new subsection (b) as follows, and
renumber other subsections accordingly :

(b) Notw^itlistanding any provision of this Act, the
Administrator shall have no authority under sections 6 and 7
of this Act to take any action which^the Secretary of Labor
is authorized to take pursuant to the Occupational Safety and

Health Act. In exercising authority pursuant to this Act, the
Administrator shall not, for the purposes of applying sec-
tion 4(b) (1) of the Occupational Safety and Health Act, be
deemed to be exercising statutory authority to prescribe or
enforce standards or regulations affecting occupational safety
and health.

Explanation. — The purpose of these changes is to eliminate the pos-
sibility of jurisdictional conflicts between EPA and the Department of
Labor where actions taken by one authority might otherwise preclude
or duplicate action of the other.

200

8. Interagency cooperation and coordination

Page 3, after line 17^ add the following new paragrapli :

(5) such authority over chemicals be exercised in such a
manner as to complement and supplement existing Federal
policies, regulations, and public laws regarding the protection
of health and the environment, including occupational health,
consumer safety, food, drug, and cosmetic authorities.

Page 28, line 3, delete the sentence after "coordination. — " and insert
in lieu thereof :

In administering the provisions of this Act, the Adminis-
trator shall consult and coordinate with the relevant agencies
and instrumentalities of the Federal Government in accord-
ance with the policies set forth in section 2(b) of this Act.

Page 30, line 2, delete the last sentence of subsection (a) and insert
in lieu thereof :

The Administrator is authorized to make contracts and
grants for research and monitoring as necessary to carry out
the purposes of this Act in consultation with the Secretary of
Health, Education, and Welfare on such contract and grant
programs.

Page 30, line 7, delete entire subsection (b) and insert new subsection
(b) as follows:

(b) The Council on Environmental Quality in consultation
with the Administrator, the Secretary of Health, Education,
and Welfare, the Secretary of Commerce, and the heads of
other appropriate departments or agencies, shall coordinate a
study of the feasibility of establishing ( 1 ) a standard classifi-
cation system for chemical compounds and related substances,
and (2) a standard means for storing and for obtaining rapid
access to information respecting such materials. A report on
such study shall be published within 18 months after enact-
ment of this Act.

Expl/jfn/ition. — ^These proposed amendments are intended to clearly
set forth that it is the policy of the Act that there be the maximimi co-
operation and coordination among the several agencies of the Federal
Government which have programs and responsibilities concerned with
toxic substances ; that the Act is intended to complement and supple-
ment existing laws and regulations such as the Federal occupational
health and safety requirements; and that appropriate provisions are
made to establish and to have access to information relating to chemi-
cal compounds.

A number of Federal agencies, particularly the Occupational
Health and Safety Administration of the Department of Labor have
extensive responsibilities relating to toxic substances and human health
and would stand to benefit from various provisions of thie Act. The
testing of chemicals as they relate to the programs of these agencies
and the test results and other information and data generated by the
legislation would, of coui*se, be valuable to them and must be made
available.

201

• 85

One of these amendments specifically provides that the EPA Ad-
ministrator will consult with the Secretary of Health, Education, and
Welfare on any contract and ofrant programs for carrying out the
research and monitoring activities under the Act, but not necessarily
on each individual contract or grant.

We are also recommending that the provision contained in the
previous bills before the Congress directing the Council on Environ-
mental Quality to coordinate a study on the feasibility of establishing
a standard classification system for chemical compounds and means
of obtaining rai)id access to tlie information on such substances be
restored to the Act. This section provides CEQ to have the lead in
establisliing information systems in a manner currently being initiated.
This is being done in conjunction witli the agencies that would have
been represented on the interagency committee as set out in tlie pro-
vision proposed to be deleted.

0. AddiftOTinl ass/'.'^frrnf ac^Tninhfrafor

Page 28, line 15, delete subsection (a), renumber subsections (b)
and (c) accordingly.

ExplanaMov. — This amendinont would deleie the provision for a
special category Assistant Administrator for Toxic Substances.

10. Administrative inspections

Page 31, line 6, insert "(a)" after "Sec. 12", and after line 21 insert
new subsection (b) :

(b) Notwithstanding the provisions of subsection (a), the
Administrator shall have authority to inspect financial data
records pertaining to testing costs when he orders contribu-
tion or reimbui^sement for the costs of performing tests in
connection with the provisions of sections 4(c) and 5(f).
Explanation. — Section 4(c) and 5(f) authorize the Administrator
to determine the equitable contribution or reimbursement of testing
costs where more than one person benefits from the testing. This
amendment would authorize access to financial data on testing costs
in order for the Administrator to carry out the requirement to appor-
tion the costs among those benefits from the testing.

11. Disclosure of can-fidential information

Page 34^. line 18, delete entire section 15 and insert in lieu thereof
the following revised section :

CONFmENTlALITT

Sec. 15. (a) Centrai^ — Any information reported to, or
otherwise obtained by, the Administrator or his representa-
tive under this Act/ which is exempt from mandatory dis-
closure by reason of section 552(b) C4) of title 5, United
States Code, shall be entitled to confidential treatment and
shall not be disclosed by the Administrator or by any officer
or employee of the United States, except that such informa-
tion may be disclosed.

(1) to officers and employees of the United States in
connection with their official duties :

(2) to contractors with the United States and em-
ployees of such contractors, if in the opinion of th? Ad-

202

mmistrator such disclosure is necessary for the satisfac-
tory performance by the contractor of a contract with
the United States entered into on or after the effective
date of this Act for the performance of work in con-
nection with this Act ;

(3) when relevant in any proceeding under this Act,
except that disclosure in such a proceeding shall be made
in such manner as to preserve confidentiality to the ex-
tent practicable without impairing the proceeding; or

(4) to the extent that the Administrator determines
it is necessary to protect health or the environment.

(b) Access by ConcxRess. — Notwithstanding any limitation
contained in subsection (a) or any other provision of law,
all information reported to or otherwise obtained by the
Administrator or his representative under this Act shall be
made available upon written request of any duly authorized
committee of the Congress.

(c) Criminal Penaett for Wrongful Disceosure. — (1)
Any officer or employee of the United States, or former officer
or employee of the United States, who by virtue of his em-
ployment or official position has obtained possession of, or
has access to, material which is entitled to confidential treat-
ment under subsection ( a), and who laiowing that disclosure
of the specific material is prohibited by this section, willfully
discloses the material in any manner to any person not en-
titled to receive it, shall be guilty of a misdemeanor and
fined not more than $5,000.

(2) For the purposes of this subsection fc), any contrac-
tor with the United States who is furnished information pur-
suant to subsection (a) (2), and any employee of any such
contractor, shall be considered to be an employee of the United
States.

Exflmwitim. — This section should be amended in several respects
First, the substance criterion for withholding data as confidential
should be the test established by the Freedom of Information Act, 5
U.S.C. 552(b)(4). Our proposed amendment would have the effect
of requiring nondisclosure of information obtained under the Toxic
Substance Control Act which may be withheld under 5 U.S.C. 552
(b)(4), i.e., "trade secrets and commercial or financial information
obtained from a person and priveleged or confidential." This will make
the confidentiality standard more definite (because there exists a body
of case law interpreting 5 U.S.C. 552(b)(4)), and will promote
uniformity.

203

which imposes penalties on Government employees for wrongf'ul use
or disclosure of information entitled to confidentiality, Go\nernment
contractors and their employees are to be considered Governnlent em-
ployees (5 U.S.C. 55'2a(m). AVe recommend inclusion of such a pro-
vision in the toxic substances proposed bill. Our amendments allow
disclosure to contractors, and include a penalty for wrongful disclosure
of information by Government employees (including contractors and
tlieir employees).

We also believe that the provisions relating to qualified scientists
and individual names are not necessary. The term ''qualified scientists''
vrould be difficult to interpret, and in any event a scientist would have
no greater rights under the subsection than would any person under
our (proposed) basic confidentiality criterion. We believe- that the
Federal Privacy Act and the Freedom of Information Act provide
ample protection of the rights of individuals whose names appear in
health and safety records.

Finally, with regard to access of information by Congress, we
believe that release of such confidential information should be upon
written request.

12. ^tate exemption from Federal preemption
Page 42, line 14, delete subsection (b).

Fxplanati-on. — This amendment would delete the pronsion that
w^ould allow State and local governments to petition to be exempted
from Federal preemption requirements.

13. Citizen suits for discretionary action

Page 45, line 13, delete language after ''Act" through line 16, and
insert in lieu thereof: "which is not discretionary with the Adminis-
trator.".

Explanation. — This amendment would make the provision conform
with the usual citizen suit provision and not authorize suits against
the Administrator for discretionary acts. It would thus prevent the
possibility of .every decision of the Administrator from being re-
decided in the district courts.

14. I ndemmfication study

Page 52, line 17, delete all of section 25 and renumber section 26
accordingly.

Explanation. — This amendment would delete the requirement for
a study on Federal indemnification under laws administered by EPA.
We believe sufficient information already exists to recommend against
indemnification under programs administered by EPA.

15. Suhndss^ioyis of budgets and, testimony to Congress
Page 54, line 15, delete all of subsection (c) .

Explanation^ — This amendment would delete the requirenient that
Agency budget requests, testimony and comments on legislation must
not be submitted to OMB prior to submission to Congress. We continue
to object to this provision.

16. Addituyj-iul miscellaneous amendments

Page 2, line 16, add after "substances": "which may present an un-
reasonable risk to health or the environment."

204

Page 3, line 8, insert after "to" the following : "ensure that adequate
testing is conducted by those persons who manufactui-e, import or
process, to ".

Page 5, line 17, after "ecological studies" insert "monitoring
studies,".

Page 8, line 4, delete "proscribed" and insert "prescribed".
Page 8, line 20, insert after "that" "one or more of the following".
Page 8, line 24, insert after "synergistic properties," "persistence,".
Page 10, line 6, delete "section 5 (g) " and insert "section 5(f) ".
Page 22, line 12, delete "any".

Page 22, line 13, delete "threat" and insert in lieu thereof "risk".

Page 29, line 1 5, delete the period and add "if appropriate.".

Page 33, line 20, delete "delivery" and insert in lieu thereof "re-
lease"; line 22, delete "three months" and insert in lieu thereof "90
days"; and on line 25, delete "deliver" and insert in lieu thereof
"release".

Page 34, line 1, after "decision" insert "by the Administrator"; line
4. delete "article, together with the" and insert in lieu thereof "article
as set forth in the Customs entry plus the estimated"; line 5, delete
"forfeiture of" and insert in lieu thereof "liability for assessment of
liquidated damages equal to"; line 6 delete "refusal" and insert in lieu
thereof "failure"; line 10, delete "delivery" and insert in lieu thereof
"release" ; line 11, insert a comman after "payment" and delete "of and
the comma after "charges"; and on line 16. delete "of subsection (a)".

Page 39, line 5, "section 17," should read "section 16,".

Explanation. — These amendments are technical corrections or are
otherwise self-explanatory.

205

ADDITIONAL VIEWS OF MR. BAKER

In my view, the Toxic Substances Control Act which is die subject
of this Committee Report represents a considerable improvement over
past efforts to develop le<rislation in this field, and I support the bill.
There is clearly a need for re^rulatory^ authority which can, where pos-
sible, identify and control the introduction of harmful substances into
the environment before damajre to health or the environment occurs.
This bill permits regulation of toxic chemicals at points in the chain
of manufacture and use that are impossible to reach under exist in^::
laws. In addition, the concept of premarket screening Tvill, in some
cases, prove a boon to industry by providing a mechanism whereby a
hannful substance can be halted before a manufacturer has invested a
g]-eat deal of time and money in marketing and distributine: it.

'WHiile I opposed some of the amendments which were added to the
measure during the Committee's mark-up. I will confine these views
to a discussion of one section of the bill which was the sui)ject of an
amendment I offered. Unfortunately, that amendment was rejected by
iho Committee.

Section 4(e)(1) of the bill as reported creates an interagency advi-
sors^ committ^^e to advise the Administrator as to those chemicals
which should be priorities for testing. The priority list is required to
be published in the Federal Register, and the Administrator is required
to institute a rulemaking procedure to develop testing requirements on
these chemicals within 1 year or publish his reasons for not doing so.

These reouirements pose several problems for both the industry and
the Administrator which I believe the Committee has negle^tod to
address adequately. First, publication of a priority list in the Federal
Register is likely to generate a good deal of publicity in the media
which will inevitably result in a perception by the public that chemi-
cals on the list are harmful, even though they will not, at this point,
have undergone testing for toxicity. This "blacklisting" effect will, in
my opinion, work a substantial unfairness on manufacturers of prod-
ucts which contain a chemical appearing on the list.

While T feel strongly that the public should be advised of hannful
chemicals in the marketplace, I see little or no benefit in mandatory
disclosure of the advisory committee's list prior to any decision by the
Administrator that those chemicals do, in fact, meet the criteria for
testing established by the bill. Other sections of the bill provide for
disclosure to the public of test data received by the Administrator, as
well as information received when a chemical undergoes premarket
screening. Moreover, section 14 of the bill requires the Administrator
to disclose any information he has if he determines it is necessary to
protect human health or the environment. These provisions insure
continuing dissemination to the public through the Federal Register of
information pertaining to the administration of the Act.

(89)

206

Secondly, I do not believe that requiring the Administrator to take
action on the advisory committee's list within 12 months or publish
his reasons for not taking action is consistent with the proper role of
an advisory committee. This requirement effectively removes the deci-
sion on whether to require testing from the Administrator and places
it in the hands of the advisory committee — an entity not responsil:)le
for administration of the Act. The priority list developed by the com-
mittee should be received and evaluated by the Administrator as a
recorrimetidation. By requiring that he act on the advisory committee's
recommendation, the bill removes from the Administrator the flexi-
bility which he will need to make responsible decisions on the testing
of chemicals.

Howard H. Bakeh, Jr.

SENATE COXSIDERATIOX OF S. 3149

[Excerpt from the Congressional Record, Mar. 26, 1976, Senate, pp. S4397-S4432]

Toxic Substances Control Act

The Senate continued with the consideration of the bill (S. 3149)
to regulate commerce and protect human health and the environment
by requiring testing and necessary use restrictions on certain chemi-
cal substances, and for other purposes.

Mr. TuNNEY. Mr. President, today the Senate will be considering
S. 3149, the Toxic Substances Control Act. In my view this legislation
is the most important environmental and health protection legislation
that will come before the Congress this session. S. 3149 will close major
gaps in the law that leave the public inadequately protected against
the unregulated introduction of hazardous chemicals into the environ-
ment. S. 3149 will assure that chemicals will receive careful premarket
scrutiny before they are manufactured or distributed to the public.
This provision will end the present situation where chemicals can be
marketed without notification of any governmental body and without
any requirement that they be tested for safety. Thus, this legislation
will no longer allow the public or the environment to be used as guinea
pigs in order to determine the safety of these chemicals and products.

Mr. President, S. 3149 was reported unanimously from the Senate
Commerce Committee. Furthermore, support for a strong toxic sub-
stances bill is extremely widespread. Dr. Russell Peterson, Chairman
of the Council on Environmental Quality for example, concluded at
last year's hearings:

Toxic substances legislation is probably the most important environmental
legislation now before the Congress,

This view was echoed in a February 28, 1976, Washington Post edi-
torial which stated in part :

In light of all that has been learned about environmental threats to health,
it hardly seems unreasonable for Congress to require that substances should not
be marketed until their health effects have been assessed as well as possible, and
no serious hazards have been found. That course will not produce a world en-
tirely free of risk. But it will inject far more care into the realms of chemistry
and slow down the rate at which strange substances are spread about. Given the
persistent and insidious nature of many toxic materials, precaution is not just
important but imperative.

The need for this legislation has become increasingly clear. In the
last 3 years, for example, I have chaired hearings before the Senate
Committee on Commerce which have documented time and again the
lethal dangers associated with chemicals like vinyl chloride, bischloro-
methyl ether— BCME— mercury and other heavy metals, arsenic, as-
bestos, and a multitude of others. In fact, over the 15 days of hearings

(207)

208

conducted by the Committee on Com'hierce on this legislation over the
last 5 years, in excess of 100 chemicals have been mentioned as candi-
dates for regulation under this legislation.

Also, the National Cancer Institute has estimated that 60 to 90 per-
cent of the cancers occurring in this country are a result of environ-
mental contaminants. Many doctors and scientists now believe that
cancer, which has been projected to kill as many Americans in 1975 as
all the battle deaths in Vietnam, Korea, and the Second World War
combined, appears particularly susceptible to a preventative approach
through control of toxic substances.

It is indeed unfortunate that while the record of chemical dangers
continues to grow, segments of the chemical industry have presented
roadblocks at every juncture of this bill's development. There is no
question in my mind that a statute would now be on the books provid-
ing effective protection against chemical hazards had it not been for
the concerted effort of certain segments of the chemical industry to gut
the essential provisions of this legislation.

Russell Train, Administrator of the Environmental Protection
Agency, for example, discussing this lobbying effort has noted :

It is unfortunate that some segments of the chemical industry, which origi-
nally took an extremely constructive approach toward the legislation, has taken
to actively lobbying against it, I do not believe that either the public interest, or
the interests of the industry, are well served by charges that the legislation
could — in words of one industry spokesman — "cripple" the chemical industry and
give the Administrator of EPA "near-dictatorial authority over the introduction
of new chemical products." The only real "crippling" that is going on is the kind
which this legislation would try to prevent — the crippling of who knows how
many Americans every year who contract cancer or some other affliction after
exposure to some hazardous chemical agent. Nor has it been on the "near-dicta-
torial authority" of the EPA Administrator that so many such agents are intro-
duced into the environment without any effort to find out what their health effects
are, much less the public have any say about whether or not, or in what circum-
stances, it is willing to be exposed to them. Let there be no mistake; the only
kind of authority that the legislation before the Congress would give us, the only
kind of authority we would intend to exercise, is the authority to act reasonably
and responsibly in the public interest — and that includes the very real interest
the public has in a healthy and productive chemical industry.

In order to provide EPA adequate regulatory authority, the Toxic
Substances Control Act will provide a mechanism to insure that that
information with respect to health and environmental effects of chemi-
cals can be collected from manufacturers and processors of chemical
substances prior to manufacture. The bill contains the following im-
portant provisions :

Eirst, manufacturers of new chemical substances must irive notifica-
tion to EPA 90 davs in advance of first manufacture and. if required
by EPA, include test data along with such notification [Sec. 5].

Second, the EPA Administrator may require manufacturers to test
or have tested those chemical substances which he determines may
present an unreasonable risk of iiijury to health or the environment
or those for which significant human or environmental exposure takes
place or will take place. This provision is applicable both to new and
existing chemical substances [Sec, 4],

Third, manufacturers or processors of chemical substances are re-
quired to retain certain records and reports that will better enable the
Administrator to determine if unreasonable risks exist. Also manufac-

209

turers must provide the Administrator with a list of health and safety
studies on various chemical substances. The Administrator is author-
ized to require the submission of any study on the list. This provision
is included due to the fact that, in hearings of the Committee on Com-
merce that I chaired, it was strongly alleged that health information
that suggested certain chemicals were dangerous had been suppressed
by industry from both the (jovernment and chemical workers [Sec. 8].

Fourth, citizens are authorized to bring suit to enjoin violation of
this act and to require the Administrator of EPA to perform his
mandatory duties [Sec. 20].

Fifth, citizens are authorized to petition the Administrator to take
action the purpose of which is to protect against unreasonable risks of
injury to health or the environment. If the Administrator fails to take
action within 90 days on such petition or denies it, judicial review of
the denial or failure is authorized [Sec. 21].

Sixth, discrimination against any employee who participates in
proceedings, testifies in a proceeding, or participates in any other
action necessary to carry out the purposes of the legislation is pro-
hibited. The legislation also sets up procedures to protect such
employees [Sec. 23].

Certain industry representatives have claimed that this legislation
will be detrimental to the economic health of the chemical industry. I
believe this view is totally unjustified. The chemical industry in the
last year had estimated sales of over $100 billion. The Environmental
Protection Agency and General Accounting Office both have estimated
that the costs of this legislation will be somewhere between $100 and
$200 million a year. This cost is completely justified in light of the
need for protection of the public from potentially vast damage to
health and the environment.

The chemical industry will reap very real benefits from this legis-
lation as well. A prudent approach of premarket investigation and
scrutiny will reduce the likelihood that we will have to take action
against a chemical after industry has invested vast resources in its pro-
duction and marketing, f'urthermore, as Russell Train has pointed
out —

Far from stiffling innovation toxic substances legislation should serve to en-
courage the industry to turn its remarkable skills and resources towards the
discovery and use of less hazardous chemicals.

^Ir. President, I do not think there is a way to assure a risk free
society. However, the Toxic Substances Control Act will end the situa-
tion where we play Russian roulette by introducing vast numbers of
untested chemicals into the environment. This legislation will assure
that we will no longer thave to wait for a body count or serious health
damage to generate controls over hazardous chemicals. Mr. President,
in closing these remarks I would like to provide a partial list of the
groups that have called for strong toxic substances legislation :

AFL-CIO.

Blue Cross Association.

American Lung Association.

Center for Science in the Public Interest.

Consumer Action Now.

Consumer Federation of America.

210

Environmental Action.
Environmental Defense Fund.
Environmental Lobby.
Environmental Policy Center.
Friends of the Earth.

Industrial Union Department, AFL-CIO.

Lea^iue of Women Voters.

National Audubon Society.

National Foundation— March of Dimes.

Natural Eesources Defense Council.

National Wildlife Federation.

Oil, Chemical and Atomic Workers.

Pulp and Paperworkers.

Sierra Club.

Textile Workers.

United Auto Workers.

United Mine AVorkers.

United Steel Workers.

Urban Environment Conference.

When I became a member of the Committee on Commerce 3% years
aofo. Senator Ma;^nuson asked me if I would be interested in chairing
some hearings on the toxic substances bill, inasmuch as the bill had
been before the committee for the preceding 2 years and there had not
been any final action taken, as a result of the very strong lobbying in-
fluence of the chemical industry. So, approximately 31/2 years ago, I
started holding hearings on the legislation, with the idea of being
able to move it quickly through Congress. We were able to get it
through the Senate without any difficulty 3 years ago. Then we got to
conference, and it was very clear in conference that the chemical indus-
try had marshaled its forces and was going to do everything it could
to sabotage the legislation in a way that was considered unacceptable
not only to the Environmental Protection Agency, but to the Senate
conferees as well.

I must say that I have never seen such an effective lobbying effort
as was done against this legislation. I was the chairman of the Senate
conferees and, for a period of 18 months we sat in conference with no
appreciable headway being made because some of the vital provisions
of this legislation, such as permarket notification, were provisions that
were unacceptable to the House conferees. We could not get the spokes-
men against the legislation who were on the conference committee to
agree to ameliorating the strong opposition that they had to those
provisions in the legislation.

But a lot has happened in the last 2 years. Particularly, a lot has
happened in the way of educating the public in the last several months.
We had a 60-minute CBS television special which outlined the impact
of environmental cancer on society. We haA^e had the National Insti-
tutes of Cancer come out with studies demonstrating that between 60
and 90 percent of cancer is environmentally induced. We have, had a
cover story in Newsweek demonstrating the impact of environmental
cancers on our society. We have had, in the last year, a large increase
in the rate of cancer afflicting society, some 3 percent last year over the
year before.

211

I introduced into the Record yesterday an article which showed that
cancer has now become the number one killer of youngsters 15 and
under. There does not seem to be any question that it is the enyiron-
mental carcinogens that are producing this cancer in youngsters.

In other words, Mr. President, what I am saying is that I think that
tliis legislation is yitally needed and. despite the fact that there may
be significant costs to the industry, it is going to saye the public
billions and billions of dollars in medical treatment to get rid of can-
cer. And, of course, it is going to saye, in my yiew, thousands of liyes.

The thing that we haye learned in recent years about cancer which
is so deyastating for those of us who are concerned about our friends
and our families is that you can be exposed to a carcinogen and neyer
know that you haye been exposed to it. It is a silent death. It takes
maybe 20 to 25 yeai^ to kill you, but that death is just as sure in some
instances as haying put a reyolyer to your temple and pulled the
trigger and haye a bullet go into your brain.

I was horrified to learn that we haye asbestos in many of our body
powders, and that Ayhen youngsters' mothers put powder on them, this
can be inhaled into their lungs and that asbestos sits in the follicles
of the lung and can produce cancer 20 years later.

In the late forties or early fifties, we used to spray the ceilings of
our schools with asbestos and now this asbestos is flaking off and can
get into the atmosphere of the school, the classroom, and children can
inhale it and, in 20 or 25 years, die of cancer.

The same is true of yinyl chloride. Back in the late forties and early
fifties, workers were exposed to yinyl chloride in a way that could
produce cancer today. People working in the factories would go down
and work in the reaction yats with the yinyl chloride all around them,
inhaling it at a leyel of parts per million that, if they were all sus-
ceptible to cancer, was sure to produce the cancer. Lord knows how
many people are going to die of yinyl chloride-induced cancer.

The point simply is we haye learned a tremendous amount about the
causes of cancer in the last 25 years, not so much as we would like to
learn about how to cure it, but an awful lot about the causes of cancer.
It seems to me that this legislation, which is designed to giye the
Enyironmental Protection Agency a degree of regulatory control oyer
the introduction of new chemicals into the enyironment, is absolutely
basic. I haye many friends who are in the chemical industry. But I
cannot imagine persons arguing against this degree of regulatory con-
trol oyer the industry.

As I say, if you are going to cost it out on an economic basis, on the
basis of cost/benefit, you are going to find it is going to saye billions
of dollars to consumers in medical treatment that they will not need
as a result of not being exposed to carcinogens in future years.

I would like to say that I deeply appreciate the leadership that has
been shown by the chairman of the full committee. Senator Magnuson,
in ])ushing tliis legislation for the past 5 years. If it had not been for
his interest and his keeping the pressure on I do not know, but I am
sure we would not haye the hiW before us today.

Mt, ^NIagnusox. ^It. President, I rise to strongly urge the passage
of the Toxic Substances Control Act. The Senate Commerce Com-
mittee has worked diligently on this legislation, and I belieye the com-
mittee has brought forth an excellent legislatiye package. The Senate

212

Commerce Committee has been concerned with developing methods to
control toxic substances for more than 5 years. During this period,
the committee has held 15 days of hearings and received testimony
and submissions from numerous experts representing the views of all
the affected groups.

Despite the complex nature of this legislation, the Senate Commerce
Committee was able to report the toxic substances bill unanimously on
February 17 of this year. In my view, we have reported a tough, fair,
and comprehensive legislative solution to the ever-growing toxic
chemical problem in this Nation.

This legislation requires the Administrator of EPA to carefully
consider the costs and benefits involved in promulgating rules under
the testing and restrictive authorities sections of this legislation. These
provisions will help to insure that regulation under this legislation
will be constructed so as to impose the least burden on industry and the
general public [Sec. 6].

A prime example of the type of threat to human health and the en-
viromnent which this bill is intended to prevent is that posed by
PCB's. This class of chemical is not only toxic but is also exceedingly
persistent. Once released into the environment PCB's present an ex-
tremely long-term threat. Furthermore, PCB's are highly concen-
trated by aquatic life so that fish at the top of the food chain have
been found with alarming concentrations of PCB residues. There was,
for example, a serious incident concerning PCB's in my own State of
Washington in September 1974. An inadequately crated electrical
transformer containing almost 300 gallons of PCB's was dropped on
a dock while being loaded for shipping to Alaska. The casing cracked
and let PCB's leak directly into the Duwamish Waterway. The trans-
former was allowed to simply sit on the dock for a number of days, all
the while leaking PCB's into the waterway.

Toxic substances legislation could greatly reduce or even eliminate
the chance of this type of incident occurring again. Under this legisla-
tion, the Environmental Protection Agency would have the authority
to require that proper precautions are taken in the handling and trans-
l^ortation of devices containing toxic substances. Furthermore, proper
labeling could be required with instructions on what to do should any
accident occur.

Of course, PCB's are only one example of the type of danger this
legislation would combat. Our hearings have revealed or examined the
potential dangers of a multitude of other chemicals, including mer-
cury, asbestos, vinyl chloride, and fluorocarbons.

Mr. President, the public has a right to expect that the vast array
of chemicals that have become an intrinsic part of our daily life have
been carefully scrutinized to determine whether they are safe. The
Toxic Substances Control Act will provide this assurance. In closing
I would like to particularly cite the work of Senators Tunney and
Hartke concerninir the Toxic Substances Control Act. Their efforts
Avere extremely valuable in facilitating the progress and development
of this legislation. I believe they both deserve a great deal of credit.

The Senator from California mentioned something to the effect that
we have been very active in the Commerce Committee over the years
in many of these areas, and I personally am very active as the chair-
man of the Subcommittee on HEW Appropriations in the cancer

213

field. As a matter of fact, the first bill I introduced in the Congress of
the United States in 1938 as a young Member of the House of Kepre-
sentatives established the National Cancer Institute.

But, getting back to this, the Senator from California mentioned
youngsters. All of us, every member of the Commerce Committee,
worked hard on the bill that dealt with flammable fabrics. A great
many kids were being burned up by pajamas and sleep wear catching
fire. But finally the Commerce Department required of the textile
people, the manufacturers, that clothing be put on the market w^hich
is iionfiammable.

AVell, it turned out that the clothing is nonflammable but it also
turns out that here is some evidence to the effect that the chemicals
they put in the cloth to make it nonflammable might cause cancer. We
are now liaving an investigation of it, and there is pretty clear evi-
dence.

If this bill had been enacted — and I know what the delay was about,
the Senator from California mentioned it, it is well known to the
Senator from Indiana, about all the problems were had on this, but
had this bill been enacted, and if the conference the Senator men-
tioned had reported a bill back to us — there w^ould not be the kind of
chemicals in the nonflammable fabrics for the kids that there is there
now.

I suppose the industry said — "Well, we will put this chemical in
and it will stop a pair of pajamas or something else from burning up
and killing the kid or burning him so that he is disfigured and crippled
for life." But nobody examined what they were going to put into these
things.

I understand for the purposes of the Record that they all do not
use the same chemical, but there are some of them — and the major use
is what we are talking about.

So the importance of getting this bill passed and getting it moving
is that it can apply to all these kinds of problems. It just so happened
this was called to my attention this week after we had worked a long
time to get industry finally to develop nonflammable children's wear,
so that these thousands of kids would not be burned.

This bill will- provide that when the textile people decide to make
something nonflammable it is going to have to be tested to see what
kind of chemical it is going to be and w^hat its other after-effects or
side effects are going to be. That is just one example of how^ very
important this bill is.

I wanted to also say, Mr. President, that I do not know of any bill
in which I have had the complete cooperation of everybody on the
Commerce Committee to try to work out this matter. I pay my respects
to the Senator from California (Mr. Tunney) who worked so hard
and so long in the hearings; the Senator from Indiana, who did a yeo-
man's job in trying to solve some of these problems so that the indus-
tries would accept what we are trvinjr to do; and many others too.

This is a very imnoi-tant bill. We have always said, and I have al-
wavs said, down in the Appropriations Committee on HEW, with the
millions of dollars that were expended for health and for research,
we have not paid enough attention to what we would call preventive
medicine, and that runs the gauntlet of everything.

214

This is preventive ; that is what it amounts to. I applaud the action
of the President in taking the leadership yesterday in preventive
medicine and urging the availability of shots to try to stop a new flu
epidemic.

The Senator from Indiana at one time stopped in — and I remember
this well — when we did not have enough money in HEW and all of
the doctors said, "We are going to have a rubella epidemic." We put
some more money in for rubella, and it did not happen.

Now, this is preventive medicine, and it will do a great deal for
the health of the Nation. I am so glad that the leadership decided in
a busy schedule to bring up this legislation because of the importance
of passing it quickly, if for no other reason than the one I just sug-
gested. I am sure the Senate is going to respond.

Mr. Pearsox. Mr. President, S. ^3149, the Toxic Substances Control
Act, represents a long sought and critically needed piece of legisla-
tion. Final congressional passage now of this legislation would first,
come at a time when the need to prevent unreasonable risks of injury
to health or the environment associated with the manufacture, proc-
essing, distribution, use or disposal of chemical substances has never
been greater; second, close an untenable chasm in Federal legislation
designed to protect human health and the environment, and third,
culminate over 5 years of congressional consideration of and back-
ground work on legislation designed to control toxic substances.

The wide spread introduction and use of new chemicals into our
daily environment has become a fact of life. It has been estimated that
there are presently nearly 2,000,000 recognized chemical compounds
in existence and nearly 250,000 new compounds produced every year.
Although the vast majority of these compounds are never commer-
cially produced, the Environmental Protection Agency has recently
estimated that nearly 1,000 new chemical substances are introduced
yearly into the marketplace and subsequently find their way into the
environment. Many of these substances pose unknown and potentially
high risks to human health and the environment.

While no one can argue that tremendous benefits have not accrued
as a result of many of these new chemicals, we have only recently
begun to recognize that serious human health and environmental haz-
ards are associated with the use of many of these chemicals. A partial
listing of commonly utilized and widely dspersed chemicals that have
been found to pose significant human health and environmental dan-
gers includes fluorocarbons, PCB's, kepone, vinyl chloride, asbestos,
mercury, and other heavy metals. Controlling the adverse effects such
toxic chemicals have upon the environment and human health is per-
haps the most critical environmental issue facing this Nation.

This Nation can no longer afford to accept the tragic human suffer-
ing that has resulted from our continued failure to adequately control
the manufacture and use of toxic substances. The National Cancer
Institute has recently estimated that 60 to 90 percent of all cancers
occurring in this country result from environmental contaminants. It
is thus not surprising that the highest incidence of cancer is found,
almost without exception, in large industrial areas where vast quan-
tities of industrial chemicals are manufactured and consumed. Many
birth defects and occupational illnesses have also been linked to ex-
posure to toxic substances. The costs, both in economic and human

215

terms, associated with the harmful liealth and environmental effects
resulting from exposure to toxic substances are simply no longer
acceptable. Passage of S. 3149 wotild provide a means by which the
public interest would be protected by assuring that safe and bene-
ficial chemicals continue to be introduced into the marketplace while
insuring that these chemical substances that have unacceptable health
and environmental cost associated with them are properly restricted.

Existing Federal legislation simply does not provide the means by
which adverse effects on human health and the environment can be
ascertained and appropriate action taken before chemical substances
are first manufactured and introduced into the marketplace. At pres-
ent, the only remedy available under such Federal statutes as the
Clean Air Act, the Federal Water Polhition Control Act. the Occu-
pational Safety and Health Act, and the Consumer Product Safety
Act, is to impose restrictions on toxic substances after they have been
first manufactured. The shortcomings in the present system have long
been evident; corrective action, as evidenced by the Toxic Substances
Control Act, is long overdue.

To correct such deficiencies, the Toxic Substances Control Act pro-
vides the EPA Administrator with authority to require essential and
critically needed premarket testing of the human healtli and environ-
mental effects of chemical substances and, where necessary, to regulate
chemical substances found to present an unreasonable risk to human
health or the environment. The existence within S. 3149 of a strong
premarket screening process is a key factor in the effective operation
of this legislation. We can no longer operate imder the assumption
that what we do not know alx>ut a chemical substance cannot hurt us.
Tragic results associated with too many toxic substances have taught
us that lesson all too well. Chemicals, not people, must be put to the
test.

Several key factors concerning S. 3149, in addition to the critical
provisions regarding premarket review of chemical substances, should
be noted. First, the bill would represent the only Federal environmen-
tal statute that would exercise direct control over industrial chemicals
with respect to their health or environmental effects. Thus increased
emphasis and attention will be focused on these very important issues.
Second, the bill provides for an ongoing mechanism that would insure
that the EPA Administrator would continually have access to new
information developed regarding adverse health or environmental ef-
fects associated with chemical substances. He would thus be able, on
an ongoing basis, to continually evaluate on a timel}^ basis the costs
and benefits associated with any chemical substance. Third, the bill
provides for both citizens lawsuits and petitions to insure adequate
and viable public input with respect to the effective administration
of the bill.

I can think of no piece of environmental legislation that is more
critically needed than S. 3149. I urge my colleagues to strongly sup-
port this legislation.

Mr. Hartke. Mr. President, the Toxic Substances Control Act has
now been pending before Congress for 5 years. This is the third time
that the Senate will consider the legislation, having passed it twice
before only to die in conference.

During the past 5 years, while Congress has struggled to enact toxic
substances control legislation, the chemical threat has continued to

216

grow. For example, approximately 5,000 new chemical substances have
reached commercial fruition during this period. The hazards asso-
ciated with chemicals like vinyl chloride, BCME, PCB's, and asbestos
have all dramatically illustrated how important it is to get early
warning with respect to new chemical substances and to have the op-
portunity for gathering test data and taking regulatory action with
respect to chemicals at the earliest possible time.

During this 5-year period there have also been in excess of 1 million
deaths in this country from cancer. Over a million infants have been
born with physical or mental damage. The latter figure represents 7
percent of all births.

Mr. President, it is extremely important that these kinds of statistics
not continue to mount. While many of the grave health risks to which
human beings have declined in recent years, cancer statistics have done
just the opposite. In fact, the incidence of cancer was estimated in
1975 to be some 21/2 percent above the previous year.

The National Cancer Institute and the World Health Organization
have estimated that from 60 to 00 percent of cancer is environmentally
induced. It is estimated that cancer costs alone in this country exceed
$18 billion annually.

It is no accident that the hot spots for cancer in this country are in
close proximity to those locations where the chemical industry is most
highly concentrated. For example, excess bladder, lung, liver, and
ot her cancers among males are all concentrated in those counMes of the
United States where the chemical industry is most concentrated.

It is indeed unfortunate that most adverse effects associated with
chemical substances first appear in the workplace. It is tragic that
those Avho rely upon the industry for jobs have essentially become
guinea pigs for discovering the adverse effects of chemical substances.
It is also tragic that much of the information which has shown the
cancer producing potential of many chemicals has come from death
records of employees. For example, of 1 million current and former
American asbestos Avorkers who still survive, fully 800,000 have been
projected to die of cancer. This death rate is 50 percent higher than
that of the United States population at large.

It is the goal of this legislation to provide a means of preventing
this suffering and death rather than merely reacting to it or treating
it medically after the fact.

One of the chief stumbling blocks in the past which prevented
agreement between the House and the Senate was the strong Senate
posit^ion with respect to premarket notification for new chemical sub-
stances. And the House and Senate seem to be moving together on this
issue. It is this provision which offers the greatest potential for dis-
covering the threats from chemical substances at a very early date and
providing a sufficient data base to take appropriate early action. None
of the other environmental health statutes, except pesticides and drug
and food additives law, provide for premarket review by appropriate
regidatory officials. In fact, this is probably the most important provi-
sion of the act, for it will enable us to limit chemical threats before
they become manifest, not after.

Quite frankly, I had reservations about earlier versions of the Toxic
Substances Control Act. But in my view, the Committee on Commerce
acted extremely responsibly in unanimously ordering this legislation

217

favorably reported. I am extremely pleased to join the Senator from
California in being an original cosponsor of the bill reported by the
Committee.

In my view, the bill provides all of the essential elements for a proper
regulatory program. The premarket screening authority will provide
early warning systems for hazards to health and the environment. The
bill appropriately limits the authority of the EPA Administrator un-
der the major regulatory provisions. The bill recognizes other Federal
authority and provides direction for the EPA Administrator in ad-
dressing hazards which might be reachable under other Federal
statutes.

It is worth dwelling for a brief moment on the economic burdens
that this legislation might impose and the manner in which the com-
mittee has addressed these types of concerns.

There have been widely varying estimates from the chemical indus-
try of the total cost to the industry of this legislation. Estimates have
ranged from the Dow Chemical estimate of $2 billion per year doAvn
to the low estimate of the Manufacturing Chemists Association of $340
million per year. The Environmental Protection Agency, on the other
hand, estimated that the total annual cost to the chemical industry
from this legislation would range only from $80 to $140 million per
year.

At the request of the connnittee, the General Accounting Office ex-
amined these estimates. The GAO report seriously questioned the high
estimate of Dow Chemical and the Manufacturing Chemists Associa-
tion and stated that EPA's estimates were more reliable and realistic
and would cost the chemical industry between $100 to $200 million per
year.

It is extremely important to note that in the testing section and in
the key regulatory sections it is specifically required that the Admin-
istrator evaluate the risks and benefits of his actions l)efore taking
action. Thus, costs are not to be incurred unless the Administrator has
determined they are offset by benefits of at least the same magnitude.
Obviously it is not feasible to reach these kinds of decisions just on
the basis of quantitative comparisons and the burdens of human suffer-
ing and premature death are extraordinary. It is important to note,
however, that the economic burdens to be imposed by the legislation
have been recognized and appropriately dealt with.

Russell Train, Administrator of EPA, has stated :

^Ir. President, I agree wholeheartedly with Mr. Train and I urge
the Senate to pass S. 3149, the Toxic Substances Control Act.

Mr. President, I pay special tribute to the chairman of the Com-
merce Committee for demonstrating humane concern for the health
of this Nation which is embodied in this legislation.

I also compliment the Senator from California (Mr. Tunney) who
has been working on this legislation for all these many years, who con-
ducted long hearings, frequently doing it in a solitary operation, in
which he was able to provide for a continued interest in the committee,
and making sure that we did something affirmatively to control the
detrimental effect of toxic chemicals in American society.

79-313 O - 77 - 15

218

One think is quite clear from what the chairman has said. We have
had the help of the people who have been involved in the committee.
During the markup of the bill the Senator from Kansas again demon-
strated his effective leadership by helping us out of what appeared to
be some very difficult situations, and doing it in a rather remarkably
fast time. Yet at the same time preserving, not only the essential ele-
ments of the health protection embodied in the bill, but also the pro-
tection of the individual rights of all the people who could be adversely
affected.

A worker himself is directly affected and he has to make that tre-
mendously difficult choice as to whether or not he is going to work in
an environment under conditions which might affect his health. He
knows very well that if he is too critical of what happens inside his
own operation with regard to the safety and health conditions that
he may in the long run be cutting his paycheck off. On the other side,
he knows he may be cutting his life off.

There is an immediate danger to him. He probably has a tendency
to go ahead and take the chance on his life because his paycheck is
needed every Friday night. The difficulty of making sure he has a job,
and at the same time that he can live with some type of decency, pre-
sents him with a difficult challenge.

That is very much a part of what is involved in this bill.

The other side of the conflict always comes from the industry or
the business which is involved in manufacturing the chemicals. They
see themselves perhaps placed in a position where they are dealt with
rather harshly in an area in which they may sincerely dispute what is
going on.

I think the essential element of this legislation is that it has at-
tempted to provide for the indiA^dual — not only who works, but for
the rest of American society — ^^the right to know what is in store as
far as the toxicity of chemicals is concerned.

The fact of it is that not only do the workers not Imow and the
general public not know, but in many cases the manufacturers and
distributors and business people do not know.

'What we are trying to do here is to provide some type of good judg-
ment and common sense to improve the quality of American life.

We have come into an age in which most people, maybe for the first
time in the history of man, have had a chance to spend some of their
life in somethinsr other than the mere and sheer operation of trying to
provide food, shelter and clothing. Yet when we sfet into that type
position as a result of the technological and scientific age we live in,
we still find ourselves in the situation where people are suffering the
adverse aspects of that type of complex and, progressive society.

I would like to say that this legislation is the type of legislation
which I think has the essential element of beinir, first, lefifislation
which we should pass and, second, T hope, legislation which the Presi-
dent will feel compelled to sign. I hope the House and Senate can join
hands in making sure the environment of this country is much more
desirable and that the health of this country is protected. And that as
far as the working people are concerned, that they no longer have the
fear and uncertaintv about their workinjj environment. The Nation
will reap the benefits of having healthier people by merely going

219

ahead and, making sure that we know and regulate toxic conditions in
chemical manufacturing distribution.

Mr. Tux NET. I wish to say that in response to the comments of the
chairman of the committee and the Senator from Indiana, there is no
way, in my view, the legislation could have gotten through either the
Commerce Committee this year or through the Senate if it had not
been for the work of the Senator from Indiana.

The Senator from Indiana was a very important catalyst in develop-
ing solutions where we had opposition. He was able to achieve ac-
commodations which in no way kept this legislation from being strong
and progressive in its regulatory initiatives, but, on the other hand,
did provide for some changes in the language to keep the bill from
being oppressive to industry.

It can certainly be said that the Senator from Indiana played a
critical role in getting this legislation into the shape it is, which
makes it more acceptable, in my view, to this body as a whole.

I also wish to say that the Senator from Kansas, as the ranking
minority member of the Commerce Committee, played a vital role.
If it had not been for his cooperation, time and again, I do not think
we could have had this bill here today.

I know this to be true because, constantly, he was prepared to rea-
son with those on the other side of the aisle at a time that lesser men,
perhaps, would have been satisfied to posture and to make political
points.

So the Senator from Kansas and others on the Republican side also
played a vital role here.

Mr. Pearson. I thank the Senator.

Mr. TuNNEY. Mr. President, I have a letter in my hand which I am
going to have printed in the Record, but I also am going to be quoting
from it from time to time during the debate — if there should be any
sharp challenge to the efficacy and legitimacy of this legislation.

It is a letter from Dow Chemical U.S.A. It appears over the signa-
ture of Earle B. Barnes.

But the letter is addressed to a number of different people, perhaps
30 in number, and it goes on to say :

Before long we will want to encourage the broadest and strongest possible
grass roots political action campaign in opposition to Toxic Substances legisla-
tion. Hopefully, it will be based on mail to and calls on Senators and Representa-
tives from employees, relatives, friends, distributors, vendors, customers, state
organizations, etc. The objectives are to kill the bills or to register a minority
vote sufficient to sustain a hoped-for veto or, as a last resort, to get the bills
moderated significantly through floor amendments in the House.

During the past summer we asked for mail to be directed primarily to senators
because the situation in the Senate was then at a critical stage. The response
(3,000 or more letters) was very gratifying. Many senators realized for the first
time that important numbers of their constituents were strongly opposed to
this largely unnecessary piece of bad legislation.

Now, the time is near for our big push. We are not alone in this effort.
Numerous other companies are also rallying grass roots campaigns ; the National
Association of Manufacturers has taken a strong stand in opposition, and the
MCA is now stronglv opposed to the two key bills which are, in the Senate,
S. 776 and, in the House, H.R. 10318. The latter replaced H.R. 7229, H.R. 7548 and
H.R. 7664.

So, with all this in mind, you will find the attached package of information
helpful in extending our request for action to the whole Dow U.S.A. "family"
plus others. Included are —

1. Summaries of the two bills in their current state.

220

2. Table of Existing Laws showing the overlap of a few present laws with
key features of the proposed Toxic Substances Control Act.

3. Representative paragraphs and sentences which people may wish to
draw uix)n in framing their own letters on their own (non-Dow) stationery.
We suggest that form letters not be used.

4. Lists of all Senators and Representatives plus rosters of the two com-
mittees who have responsibility for this legislation, along with suggested
forms for addressing letters to Senators and Representatives.

5. Tips on writing your Representative or Senator.

Advance briefing and planning sessions will be held with various Government
Relations managers. Then, we will write, Telex or call them when it is time to
launch this all-out effort. In the meantime. I hope you will take the necessary
preparatory action.

If you need more information, please call me or Chet Otis.

Thanks for your help, and good luck.
Very truly yours,

Earle B. Barnes.

So Dow Chemical was planning an enthusiastic, spontaneous effort,
inchidino- prepared para^^raphs which employees could draAv upon, to
bombard their Senators and Eepresentatives to show that there was
stronc^ adverse feeling on the part of a representative ^rroup of con-
stituents. It is this kind of effort, Mv. President, which for the past 5
years has kept this legislation from goinjr through the Congress and
being signed into law by the President.

I think when the kind of activities that they have engaged in are
exposed, such as they are today by reading this letter into the Record,
we realize the effort on the part of the Dow Chemical Co., eft at least
by Mr. Barnes speaking for the Dow Chemical Co., was not to address
the issue or the issues involved in the legislation based upon reason,
based upon the merit of the arguments, but simply to use a propaganda
thrust, a political persuasion which is in no way related to the merits of
the legislation.

I think it is this kind of effort which is going to do the industry in
when it comes to the effectiveness of their approach in trying to block
the legislation. I think the time has arrived for control of toxic sub-
stances. Lord knows, the last thing we need is more regulation where
it is not necessary.

One of the things that certainly I feel, and many other Senators do.
is that overregulation of industry can stifle productivity, inhibit crea-
tivity, and helps to keep the free enterprise system from operating in
a fashion that it sliould. But when we talk about regulation of toxic
substances and the prevention of these substances, these carcinogens,
from getting into the environment, and protecting the health of our
citizens, there can be no question, in my mind, that any society would
want to have its government provide the safeguards that this legisla-
tion does. It is a miracle to me that it has taken so long to get to this
point.

Mr. TuxxEY. Mr. President, I send am amendment to the desk and
ask for its immediate consideration. I offer this amendment for myself
and Senator Kennedy.

The A(^TixG PrEvSidext pro tempore. The amendment will be stated.

The assistant legislative clerk read as follows :

The Senator from California (Mr. Tunney), for himself, and Mr. Kennedy,
proposes an amendment.

The amendment is as follows :

On page 5, line 7 [sec. 3], immediately following "(vi)" insert "(A)", and
strike "or" the second time it appears.

221

On page 5, line 8, strike "any".

On page 5, line 10, strike " ( A) ".

On page 5, line 11. strike "or as any".

On page 5, line 12, strike "such", and immediately following "(B)" insert "any
substance".

On page 5, line 14, strike *"or as any such".

Mr. TuxxEY. Mr. President, I have sent to the desk a series of
clarifyin^i' amendments and I ask unanimous consent that they be
considered en bloc.

The AcTixG Presidext pro tempore. Is there objection? Without
objection, it is so ordered.

Mr. TuNXEY. Mr. President, the amendments are very minor and
only serve to clarify the manner in which substances used in or on
foods, drugs, cosmetics, or devices are excluded from the definition of
a chemical substance. Under the existing language, it is not fully clear
as to whether substances produced for research and development pur-
poses and intended only for use in or on foods, drugs, cosmetics, and
devices were sufficiently excluded. As these substances are now or will
be covered by the Federal Food, Drug and Cosmetic Act, it is appro-
priate that they not be covered here. What this amendment does is
merely to clarify the exclusion that we intended to have written into
the bill as it came out of the committee.

Mr. Pearson. Mr. President, this amendment refers to several
places in the bill, as the Senator indicates, and it is technical in nature.
We have no objection.

The AcTix'G President pro tempore. The question is on agreeing to
the amendment.

The amendment was agreed to.

The Acting President pro tempore. Are there any further amend-
ments ?

Mr. Helms. Mr. President, I send an amendment to the desk and
ask for its immediate consideration.

The Acting President pro tempore. The amendment will be stated.
The assistant legislative clerk read as follows :

The Senator frojn North Carolina (Mr. Helms) proposes an amendment:
Beginning on page 90, line 22 [sec 23], strike out all through line 6 on page 92.

^Ir. Helms. Mr. President, this amendment would delete the so-
called employment protection provision of the act, section 23(f),
Avhich is clearly unnecessary and unwise. It has nothing to do with any
discussion about toxic substances.

In the first place, section 23(f) imposes onerous bureaucratic bur-
dens on both the Environmental Protection Agency and the Employer
that will unnecessarily increase the costs of administration and compli-
ance. This section provides that "Any employee who is discharged or
whose employment is otherwise interrupted, or is threatened with dis-
charge or such interruption, or otherwise discriminated against by any
person because of the results of any rule or order issued under this act,
or a representative of such employee, may request the Administrator to
conduct a full investigation of the matter." This section provides fur-
ther that the Administrator "shall hold a public hearing on no less
than 5 days notice, and shall at such hearings require the parties, in-
cluding the employer involved, to present information related to the
actual or potential effect of such rule."

222

In other words, Mr. President, this section requires the Adminis-
trator of the Environmental Protection Agency to conduct a full-
scale adjudicatory hearing whenever he is requested to do so by any
employee or employee representative, such as a labor union official,
who thinks that a ruling issued under the Toxic Substances Control
Act may endanger his employment, either permanently or tempo-
rarily. The employer would in turn be required to appear at the hear-
ing and supply information, with only 5 days notice, relating to the
effect of a ruling on his employees. The employer, of course, will bear
the cost of making these appearances, which he will pass along to the
consumer — and the consumer ought to make no mistake about that —
and the Federal agency will bear the cost of the hearings, which it will
pass along to the American taxpayer.

No matter how you look at it, the American people are going to be
paying for all of this expensive Federal bureaucratic paperwork, and
1 submit, Mr. President, that the taxpayers and the small businessmen
of this country are almost crushed under such a deluge already.

And what would it all accomplish ? If past experience with similar
regulatory measures is our guide, the act will simply produce more bu-
reaucratic harassment of the business community. Employers will un-
doubtedly be placed on the defensive by the threat of innumerable
hearings demanding that they justify each and every layoff and em-
ployment reduction. It requires no great imagination to see that many
layoffs and employment reductions, whether real or imaginary, will be
attributed to rulings of the EPA, and that employers will bfe induced
to keep unnecessary employees in order to avoid bureaucratic proceed-
ings. The added cost of labor will simply be passed along to the Ameri-
can people, increasing prices and adding to inflation.

That is something this country does not need, Mr. President.

In an industry employing more than a million persons, where some
1,000 new chemicals are introduced into the market each year, oppor-
tunities under section 23(f) for initiating these costly proceedings
seem almost unlimited.

Xow, contiary to all of the concepts of justice that I understand
and appreciate! Mr. President, section 23(f) also discriminates
aorainst the em]:>loyer and denies him equal treatment under the act.
The manufacturer of a chemical may have his product banned with-
out being afforded a full, trial-type hearing under the act, but every
employee who i^eiTeives a possible job layoff must receive a full hear-
ing, complete with proper adjudicatory procedures. This, frankly, is
not mv understanding of iustice in the American system of law, Mr.
President, and I am confident that my colleagues will join with me
in oposing sec^^ion 23(f) in reco.q-nition of its inequitable features.

In the second place, section 23(f) is unnecessary because it is dupli-
cative, lender section 6(c) CI) of the act. the Administrator is re-
quired to make findings with respect to the economic consequences of
anv rules of the EPA resrulating chemical substances that are alleg-
edly, an unreasonable risk to the public health or environment. But
surely, ^fr. President, one of the most obvious economic consequences
of any rule is the potential of emplovment reductions: and this is the
very subject which section 23( f ) commands the Administrator to eval-
uate constantly and continually. Section 23(f) is thus redundant, in

223

the opinion of the Senator from Xorth Carolina, and I believe it should
be eliminated.

Mr. President, the principles of fairness, the interests of economy,
and pride in legislative draftsmanship demand that we delete section
23(f) from this bill. I urge my colleagues to uphold these standards
by joining in support of this amendment. I hope that the distinguished
manager of the bill will agree with me and accept by suggestion.

Mr. Tux NET. Mr. President. T wish I could find in the amendment
the merits that I know the Senator from Xorth Carolina feels that it
has. I would point out to my friend that this language is identical to
a })rovision in the Water Pollution Act that was passed in 1972 and is
now on the statute books, and there has been only one case that has
been brought to the attention of the Connuittee on Commerce in which
the EPA used its authority, in the 4 years that this statute has been
on the books, to investigate alleged intimidation against a worker. It
never even got to the hearing stage. It involved a paper mill in Alaska,
and ap])arently when the employee made the charge to the Environ-
mental Protection Agency alleging discrimination by the employer,
the employer backed down and the man retained his job.

So thei e has been only one case in 4 years under an exactly similar
l)rovision in the Water Pollution Control Act.

Let me tell you what we were trying to obviate by this language in
this bill. I am going to quote from a letter that was directed to me and
to another Senator on the committer. It was a handwritten letter, di-
rected to at least the two of us ; it may have been directed to more. But
it goes like this :

I thought that you would like to know of the reaction to S. 776. Toxic Sub-
stances Control Act. I am in the chemical industry, and there is much pressure
on us to write and" oppose this hill. In fact, there is downri2:ht intimidation. We
are asked to write or phone to the committee members, and our names are written
down by our bosses and the list, in turn, ^nven to their bosses. For what purpose
I don't know, but a lot of i)eoi)le are afraid not to do as they are told.

T do not think that this is fair of industry, to put pressure like this on their
workers, and I would appreciate .someone in the Senate speaking out against this
form of "support."

Mr. Hfxms. If the Senator will yield

^Ir^TuxxEY. .This was written in February, the middle of February
of 1976. I would be hap])y to yield, but I do liave some other points I
would like to make.

^Ir. IIel:ms. Well, will the Senator yield at that point on my time?

Mr. TrxxEY. Yes.

^Ir. Helms. The Senator is making a great deal of a company's ef-
fort to opDose this bill, and I know the Senator is concerned \about
that, but this is a pait of the political process, is it not ? Labor unions
do it. but I ha\ e not heard the Senator complain about labor unions
putting pressure on their members.

I hear from union members all the time, who say to me : "Senator, I
agree with you on a ]uece of legislation, but I would catch the devil
from mv union bosses if I opposed tlieir position.'- So it cuts both ways,
and I do not think the Senator ought to complain too much about
efforts bv the biisiness community to o])]:>ose this bill Second, I think
it is fair to point out that the Senator does not know for certain
whether the facts of this letter are true : it may have been Avriten by

224

an aggravated employee, or someone else. I think that the Senator is
not justified, if he will forgive me, in stressing the importance of this
letter.

The only fact I am pointing out to the Senator, and I say this to all
of the Members of the Senate, is that if this amendment is not adopted,
there will be harassment, intimidation, and increased costs, and the
Senator will hear from it later. This is why I am opposed to this part
of the bill.

Mr. TuNNEY. Well, as I have mentioned, in 4 years, under a similar
provision, there has been one case brought to the EPA, and that did
not even get to the hearing stage. So I do not quite understand how
the Senator from North Carolina feels that this is going to result in
extraordinary cost. I can understand, if we had not had any experience
under similar legislation, such fears might be reasonable. But with the
experience that we have had of 4 years under the Water Pollution
Control Act. I would suggest to the Senator that the empirical evidence
is such that there is not much merit in the proposition that the Senator
is makinof today.

Mr. Helms. I understand what the Senator is sayinof, but I do not
understand how he relates water to an industry involving the intro-
duction of a thousand new substances a year, each of which could
have an effect along the lines that we are discussing here.

Mr. President, T ask for the yeas and nays.

The PREsroiNG Officer (Mr. Nelson). Is there a sufficient second?
There is a sufficient second.

The yeas and nays were ordered.

Mr. Pearson. Mr. President, will the Sen tor yield for a question ?
Mr. Helms. Yes.

Mr. Pearson. I wonder if the Senator intends in his amendment to
strike subparagraph 1, starting at line 22 on page 90 [sec.
23(f)(1)]. I am advised that there is in another part of the bill a
requirement of the Administrator to make an evaluation of the eco-
nomic impact of this particular legislation. That is general in nature.
This is meant to be specific or enforcing language. It has provisions
as to continuing economic implications, the shifts and reductions of
employment, and so forth, under the rules and under the act.

We are advised that that particular subparagraph is one in which
industry is very vitally concerned. I wonder if the Senator feels that
that also is a matter which should be striken out in his amendment.

Mr. Helms. Mr. President, will the Senator identify the section to
wliich he refers ?

Mr. TuNNEY. Section 23(f) assures that the Administrator of
EPA Avill assess the job impact resulting from the issuance of any rule
or order under the Toxic Substances Control Act, and that is what the
Senator from Kansas was referring to when he indicated that this is
desirable from the point of view of industry, because we should not
have an administrator issuing: rules that could result in the layoffs of
hundreds or maybe thousands of persons without evaluating that im-
pact upon t]ie workers and upon the community in which they work.

The Administrator also, under the provision, will in appropriate
circumstances investigate allegations that employers are discriminat-

225

intr ai^ainst employees as a result of any rule or order issued under
the act.

I tliink that the Senator in his amendment is really referring to this
portion of section 23(f). Section 23(f)(2) clearly states that the
EPA will only investigate, hold a hearing on an employee's complaint,
and make findings of fact.

Therefore, the Administrator is required to take this action if he
believes that an employee complaint of alleged employment effects is
"because of the results of any rule or order issued under the act."

I might point out that the Administrator can hold a hearing, and
make findings of fact and that is it. He can publicize the results of the
hearings, but he cannot order the employer to reinstate the employee
under subsection (f). I think that the manager of the company
ought to take the heat that comes with public exposure of that kind
of discrimination.

Mr. Helms. Mr. President, I ask for the yeas and nays.

Mr. TuxxEY. The yeas and nays have been ordered.

The Presidixg Officer. All time is yielded back. The question is
on agreeing to the amendment of the Senator from North Carolina.
The yeas and nays have been ordered, and the clerk will call the roll.

The assistant legislative clerk called the roll.

Mr. Robert C. Byrd. I announce that the Senator from Indiana
(Mr. Bayh) , the Senator from Texas (Mr. Bentsen) , the Senator from
Delaware (Mr. Biden), the Senator from Mississippi (Mr. Eastland),
the Senator from Alaska (Mr. Gravel), the Senator from Michigan
(Mr. Hart), the Senator from Colorado (Mr. Haskell), the Senator
from Hawaii (Mr. Inouye), the Senator from Washington (Mr.
Jackson), the Senator from Arkansas (Mr. McClellan), the Senator
from Wyoming (Mr. McGee), the Senator from South Dakota (Mr.
McGovern), the Senator from New Hampshire (Mr. Mclntyre), the
Senator from New Mexico (Mr. Montoya), the Senator from Utah
(Mr. Moss), the Senator from Mississippi (Mr. Stennis), and the
Senator from Missouri (Mr. Symington), are necessarily absent.

I also announce that the Senator from Vermont (^Ir. Leahy), and
the Senator from Louisiana (Mr. Long), are absent on official
business.

I further announce that, if present and voting the Senator from
Washinirton (Mr.- Jackson) , would vote "nay".

Mr. To^\T!:r. T announce that the Senator from Tennessee (Mr.
Brock), the Senator from Massachusetts (Mr. Brooke), the Senator
from New York (Mr. Buckley), the Senator from Arizona (Mr. Fan-
nin), the Senator from xVrizona (Mr, Goldwater), the Senator from
Michigan (Mr. Griffin), the Senator from Oregon (Mr. Hatfield), the
Senator from Nebraska (Mr. Hruska), the Senator from Nevada (Mr.
Laxalt), the Senator from Marydand (Mr. Mathias), the Senator
from Pennsylvania (Mr. Hugh Scott), the Senator from Virginia
(Mr. William L. Scott), the Senator from Vermont (Mr. Stafford),
and the Senator from Connecticut (Mr. Weicker), are necessarily
absent.

I further announce that, if present and voting, the Senator from
Oregon (Mr. Hatfield), and the Senator from Pennsylvania (Mr.
Hugh Scott) , would each vote "nay."

226

The result was announced — ^yeas 13, nays 54, as follows :

rRnllrall Vntp Nn 102 T-pp- 1

Allen

Helms

Taft

Bartlett

McClure

Thurmond

Byrd, Harry F., Jr.

Morgan

Tower

Curtis

Sparkman

Young

Hansen

NAYS— 54

XI. Lfi^ u 1 tr^ Jv

if ong

iM eioon

Baker

Tfnrri
J? iJL u

Nunn

"ROQ 11

Garn

Packwood

Bellmon

^jrienn

Pastore

xid.rL, vjrdry

1: earsou

JjUrUlCK

xiarLKe

Piiii
r^eii

xsyra, xvODeru kj.

Hathaway

Percy

XlOlllUgb

Proxmire

Case

riuutiiebLon

Randolph

Chiles

Humphrey

Ribicoff

Church

Javits

Roth

v-'iarK

Johnston

Schweiker

Cranston

Kennedy

Stevens

Culver

Magnuson

Stevenson

Dole

Mansfield

Stone

Domenici

Metcalf

Talmadge

Durkin

Mondale

Tunney

Eagleton

Muskie

Williams

NOT VOTING— 33

Ddy 11

ULciL I., X llllljj xx.

ivxnjree

indbKeii

iVX L vjr (J V c 111

Biden

XldLUtflU.

Brock

Hruska

Montoya

Brooke

Inouye

Moss

Buckley

Jackson

Scott, Hug]

Eastland

Laxalt

Scott, Will

Fannin

Leahy

Stafford

Goldwater

Long

Stennis

Gravel

Mathias

Symington

Griffin

McClellan

Weicker

So Mr. Helms' amendment was rejected.

The Presidixg Officer. The Senator from New Jersey is recognized.

Mr. Tunney. Mr. President, will the Senator yield? I ask for the
yeas and nays on final passage.

The PREsroiNG Officer. Is there a sufficient second ? There is a suf-
ficient second.

The yeas and nays were ordered.

Mr. Case. Mr. President, I have an amendment at the desk, on be-
half of myself and my colleague. Senator Williams, and I ask that
it be reported, but may it be reported in the form which I now hand
to the desk.

The Presiding Officer. The clerk will report the amendment.
The second assistant legislative clerk proceeded to read the amend-
ment.

The amendment is as follows :

On page 93, between lines 8 and 9, insert the following new section :

227

STATE DEMONSTRATION PROGRAMS

Sec 25(a). Establishment of Program. — The Administrator is authorized to
assist no more than three states in estahlishing demonstration. Programs by sueli
states to protect against unreasonable risks to liealth or the environment asso-
ciated with chemical substances and mixtures. Such programs sliall —

(A) identify and inventory chemical substances and mixtures within such
state, including their manufacture, processing, distribution, use, and
disposal :

(B ) monitor the extent to which such chemical substances or mixtures are
present in the environment of any such state and the human exposure to
such substances or mixtures within such state :

(C) establish a program to (1) prevent or eliminate unreasonable risks to
health or the environment presented by chemical substances or mixtures
Hi) integrate the control of chemical substances and mixtures under this
section with other programs of environmental and public health protection
within such state so as to appropriately minimize the overall pollution of
the environment within such state: and (iii) identify the appropriate gov-
ernmental institutions and processes neces.sary to implement a program for
the prevention of unreasonable risks to health or the environment presented
by chemical substances and mixtures ;

(D) analyze and evaluate the results of such programs through annual
reports to the Administrator ; and

(E) complement and in no way reduce Federal efforts under this Act in
such state.

(b) Reports. — The Administrator shall .«<ubmit a report to the appropriate
committees of Congress not later than July 1 of each calendar year. Such report
shall include (1) a description of progress with respect to programs assisted
under this section and any suggestions for improvement in such program. (2)
recommendations as to the manner by which programs within the states for the
prevention of unrea.sonable risk to health or the environment presented by chem-
ical substances may fea.^ibly be implemented, and (3) the extent to which the
Administrator has disseminated information regarding programs authorized
under this section to other interested .states and other i)ersons.

(c) Authorization for Appropriations. — For the purposes of providing a.ssist-
ance under this section, there are hereby authorized to be appropriated not to
exceed -$2,0()0,00() for the fi.scal year ending September 30. 1977: $2,000,000 for
the fiscal year ending September 30, 197S, and .$2,000,000 for the fiscal year
ending on September 30, 1970. Any funds appropriated under the authority of
this subsection shall remain available until expenderl. Funds available imder
this section shall not be available for programs which would duplicate any au-
thority or requirements of the Administrator under this Act. including sections
4, 5, 6 and 9(c). Funds available under the authority of this section shall support
not more than 75 percent of the costs of any .such program described under sub-
section (a) engages in by the State .

(d) Priorities. — Assistance afforded under this section shall be available
(subject to the requirements of subsection (a) ) to those states which can estab-
lish a priority need for such assistance, as determined by the rules of the
Administrator. In establishing such rules, the Administrator shall consider the
existence of serious health effects associated with chemical substances within
such state including cancer, birth defects, and gene mutations : the extent to
which chemical substances and mixtures are manufactured, processed, distrib-
uted in commerce, used and disposed of within such state : and the extent of
exposure of human beings and the environment to chemical .substances and mix-
tures within such State. The Administrator shall approve all such programs and
establish a mechanism for monitoring such programs.

(e) DIscLAI^rER.— Nothing contained in this section shall affect any provision
of section 18 of this Act.

^Ir. Case. ]Mr. President, the amendment we propose would be of
significant benefit in implementing the mandates of the Toxic Sub-
stances Control Act. It would enable selected States to develop demon-
stration programs to protect against unreasonable risks to health or
the environment associated with chemical substances and mixtures.

228

Through a demonstration program, States like New Jersey could
obtain the data necessary to make reasoned decisions as to the dangers
to humans resulting from exposure to toxic substances. It would also
provide the basis for State management measures to be proposed in
the demonstration States and elsewhere. Especially important, it
would coordinate State programs with Federal programs, demonstrat-
ing methods to minimize the burden upon industry in the require-
ments for submission of information and data to the several levels of
government that are involved in toxic and other environmental
programs.

Our amendment would provide for State demonstration grants in
no less than one, and no more than three States. The key elements of
such State ])rograms would be :

First, to identify and inventory chemical substances and mixtures in
the State at various stages in their cycle of use ;

Second, to monitor the extent to which such chemical substances or
mixtures are present in the environment of such State, and the extent
to which human beings in that State are exposed to them ;

Third, to establish a State program that would prevent or eliminate
unreasonable risks to health or the environment from chemical sub-
stances of mixtures, to integi-at-e toxic substances management pro-
grams with other environmental and public health programs so as to
minimize the overall pollution of the State's environment, and to
identify the appropriate governmental institutions and processes nec-
essary to implement such a program.

This point is of particular importance. For too long we have seen
pollution control technologies which merely serve to transfer the prob-
lem from one medium to another — such as air pollution technologies
which remove contaminants from the air and put them into the water
cycle instead. This is hardly a solution.

Fourth, to analyze and evaluate the results of such programs through
annual reports to the Administrator of EPA.

The Administrator of EPA, in turn, must submit annual report
to the Congress on the progress of the demonstration projects, recom-
mended ways for other States to implement toxic substances manage-
ment programs, and recommend additional legislation if necessary.
The Administrator's report must describe the extent to which he has
disseminated the information derived from the demonstration pro-
grams to other interested States and persons.

This is not a demonstration program to be funded and then forgot-
ten. EPA will be under a mandate to study, evaluate, and make known
what has been learned from the demonstrations, so that others will
benefit.

There is authorized for each fiscal year, 1977, 1978, and 1979, $2
million, with the Federal share of the program not to exceed 75
percent.

There are explicit provisions that these funds will not be used to
duplicate other requirements and programs. As I stated earlier, one
of the primary objectives of this demonstration program is Federal-
State coordination so as to minimize tlie burdens on industry.

Other amendment would give priority for grants under this section
to those States where the problem of the effects of toxic substances
are most acute. Specifically, the Administrator's project selection must

229

consider: First, the existence of serious health effects associated with
chemical substances within such State, including cancer, birth defects,
and gene mutations ; second, the extent to which chemical substances
and mixtures are manufactured, processed, distributed in commerce,
used and disposed of within such State ; and third, the extent of ex-
posure of human beings and the environment to chemical substances
and mixtures within such State.

Finally, this amendment assures that nothing in this new section
increases or decreases the authorities of a State, as established under
section 18, preemption.

New Jerseyans were shocked to learn earlier this year that our
State has the highest rate of cancer in the country, not for one, but
for all types of cancer. We were totally unprepared for this news.

We know that exposure to certain chemicals can cause cancer, but
there remain many, too many, unanswered questions. We need to
identify- these chemicals, find out what qualities of them pose a hazard,
and — most important — we nuist find out what we can do to reduce the
risk to Xew Jerseyans.

It seems to us that adoption of tliis amendment to the toxic sub-
stances bill would provide the means to find answers to these questions.

This amendment would be of great significance in helping our State
and other States with similar problems to develop demonstration pro-
grams to protect against imreasonable risks to health or the environ-
ment associated with chemical substances and mixtures. It provides
for demonstration programs with Federal participation jointly with
the States. It authorizes $2 million a year for 3 years, and the States
must participate to the extent of 25 percent.

I understand that the amendment is agreeable to the minority and
the majority.

Mr. Williams. Mt. President, I am pleased to join with Senator
Case in offering this amendment to the Toxic Substances Control Act.
The amendment would autliorize the FPA to establish up to three
State demonstration programs in selected States to complement the
Federal toxic substances conti-ol program. The State programs would
in no Avay reduce or replace F'ederal efforts to control toxic substances
under the act. The demonstration programs would allow a State to
inventory chemical substances within its borders and monitor the ex-
tent of human and environmental exposure to these substances.

The State would be required to integrate its program for controlling
toxic substances witli other State environmental and public health pro-
grams, and to coordinate its efforts with those of other levels of goA'-
ernment. By requiring the coordination of State and Federal efforts
to control toxic substances, the amendment would help to reduce
duplicative regulation. It would help to create greater stability of
expectations in industry and end the arbitrary and often conflicting
requirements inij^osed by various authorities which have adverse effects
on investment decisions.

Senator Case and I represent a State where the need for such a pro-
gram is manifest. Xew Jersey has both the highest concentration of
chemical plants and the highest cancer death rate in the Nation. Ac-
cording to the National Cancer Institute, this is no coincidence. A
study done by the National Cancer Institute found a high correlation
between cancer deaths and densely concentrated industry. New Jer-

230

sey's 21 counties were found to be in the top 10 percent of all counties
in the Nation for the rate of cancer deaths. Salem County, N.J., where
25 percent of the males work in the chemical industry, has the Na-
tion's highest rate of bladder cancer — an occupational disease associ-
ated with chemical exposure. These figures are no less than alarming.
This legislation and this amendment together address this critical mat-
ter in a comprehensive and coordinated way.

The immediate need at the State level is to begin to determine the
types and quantities of toxic substances already present in the environ-
ment. This cannot be done with the monitoring systems already in
place. EPA would collect the data on various chemical substances, but
it would be up to the State to follow these substances through the
circle of their use — manufacture, processing, distribution, use, and
disposal. While the amendment will not give the States any authority
to regulate workplace exposures or duplicate any authority under the
Occupational Safety and Health Act, information gathered under the
amendment could complement Federal efforts under OSHA.

Like most other States, New Jersey now^ has an extensive monitor-
ing network in both air and water. These systems are designed to
monitor the air and water for so-called classical pollutants. This net-
work is the major method by which New Jersey's Department of En-
vironmental Protection has been able to define the extent of the State's
environmental problems, as well as improvements in environmental
quality.

But for toxic substances, new monitoring stations must be estab-
lished according to different criteria, and analytical techniques must
be utilized which are much more complex and time-consuming than
those currently utilized.

The results of such a State demonstration program would be eval-
uated at both the State and Federal level and would be used as a model
for other States to build their own programs.

The final result of such a demonstration program, it is hoped, would
be to reduce the rate and prevalence of cancer and other environmen-
tally related diseases.

Mr. TuNNEY. I am authorized by my distinguished friend from
Kansas (Mr. Pearson) to indicate that this amendment is acceptable
to both the minority and the majority on the committee. This is an
amendment that will allow States the leeway in certain circumstances
to structure programs to meet particularly acute local and regional
problems and, therefore, I am prepared to yield back the remainder
of my time.

The Presiding Officer. All time yielded back. The question is on
agreeing to the amendment of the Senator from New Jersey.
The amendment was agreed to.

Mr. Case. Mr. President, I move to reconsider the vote by which the
amendment was agreed to.

Mr. TuNNEY. I move to lay that motion on the table.
The motion to lay on the table was agreed to.

Mr. Allen. Mr. President, I call up an amendment which I have
at the desk.

The Presiding Officer. The amendment will be stated.
The second assistant legislative clerk proceeded to read the amend-
ment.

231

The amendment is as follows :

On page 9, line 2, [Sec 3], after the period add the following :

"(15) The term 'unreasonable adverse effects on the environment' means any
unreasonable risk to man or to the environment taking into account the economic
social, and environmental costs and benefits of the use of any chemical sub-
stance."

On page 52, line 5, strike out all after the word "show" down to and includ-
ing the period at the end of line 11 on page 52 and substitute in lieu thereof
the following : "that a situation exists in v. hich the continued use of a chemical
substance would be likely to result in unreasonable adverse effects on the en-
vironment or will involve an unreasonable hazard to the survival of a species
declared endangered by the Secretary of the Interior under Public Law 91-135."

Mr. Allen. Mr. President, the amendment I have introduced is de-
signed to 2)rovide the Administrator of the Environmental Protection
Agency with the same definition of "imminent hazard'' and ''unrea-
sonable adverse effects'' in the Toxic Substances Control Act as are
contained in the existing law which regulates tlie testing and registra-
tion of pesticides, the Federal Insecticide, Fungicide, and Rodenticide,
Act, as amended, Public Law 92-516 and Public Law 04-140. My
amendment does not in any way weaken the ability of the Adminis-
trator to restrict the use of toxic chemical substances but it would
provide tlie consistency neded for even-handed administration of two
laws, both of which would have the same intent and both of wliich
w-ould regulate in most instances the same industries and essentially
the same subject matter.

Mr. President, when the legislation which led to the Federal Lisec-
ticide, Fungicide, and Rodenticide Act was first introduced in the
Senate, it was referred jointly to the Senate Committee on Commerce
and to the Senate Committee on Agriculture and Forestry. This joint
referral evidenced the dual jurisdiction which exists with respect to
legislation affecting the chemical industry. I would remind Senators
in this connection that Senate rule XXV 1(b) specifies that all pro-
posed legislation relating to ''agricultural and industrial chemistry"
shall be referred to the Committee on Agriculture and Forestry. Al-
though no similar language is contained in rule XXV 1(f) which sets
forth the jurisdiction of the Senate Committee on Commerce, very
properly committee jurisdiction over the legislation which led to the
enactment of the Federal Insecticide, Fungicide, and Rodenticide Act
was shared with the Committee on Commerce. Mr. President, regret-
tably such was not the case in the present instance. Had committee
jurisdiction over toxic substance control legislation been likewise
shared. I am confident the inconsistencies between the bill reported
by the Senate Committee on Commerce and existing laws could have
been eliminated without the necessity of extensive floor amendment.

Mr. President, I believe it is vitally important that S. 3149. the
Toxic Substance Control Act, if enacted, be consistent wdth existing
law in the standards to be used by the Administrator and his staff in
administerinfr the law regulating the use of chemicals. The adminis-
trator and his staff have had the opportunit}^ to apply the existing
standards contained in the Federal Insecticide, Fungicide, and Ro-
denticide Act in actions taken by the Agency in regulating the regis-
tration and use of pesticides. It would not seem prudent or logical
for the Agency, which would be responsible for the administration of
two separate laws governing toxic chemicals, to be saddled with con-
flicting language in the two laws.

232

I recently had occasion to preside at 4 days of hearings before the
Senate Subcommittee on Agricultural Eesearch and General Legisla-
tion of the Senate Committee on Agriculture and Forestry during the
course of that subcommittee's investigation of the kepone contamina-
tion of the James Kiver in the vicinity of Hopewell, Va. During those
hearings I became somewhat familiar with the composition and use of
the pesticide kepone. It should be no revelation that toxic chemicals
are used as components of agricultural poisons, such as kepone, or that
pesticides are themselves often components of toxic substances which
are manufactured for entirely different uses. The questions at issue
in examining the use or registration of pesticides, fungicides, and
rodenticides, therefore, differ little if at all from those posed with
respect to other toxic substances.

Many manufacturers avIio are producing pesticides are also produc-
ing other toxic chemical compounds, and it would be confusing and
frustrating for a manufacturer of chemical substances to be subjected
to two different standards or requirements. For example, any chemical
or toxic substance would first be subject to the provisions of this act,
and yet when it becomes a component of a pesticide, it would be subject
to FIFRA. In many instances, the manufacturer of the component is
also the manufacturer and registrant of the pesticide. It is unreason-
able to expect either the Administrator or the manufacturer to carry
out properly their responsibilities in the presence of conflicting legis-
lative language regulating chemical substances.

Throughout the bill, numerous references are made to "unreasonable
risk" without providing a definition of the term. The term is also used
in connection with other qualifying phrases which have dissimilar
connotations and which could create problems and confusion in the
administration of the two statutes. These phrases include:

"Cause or contribute to an unreasonable risk of injury to health or
the environment'" ; "present an unreasonable risk to human health and
the environment"; and "is likely to present an unreasonable risk to
health or the environment."

^ly amendment would provide that, w^henever the term "unreason-
able risk" is used it will be in accord with the meaning of "unreason-
able adverse effects" as defined in my amendment and as defined in the
Federal Insecticide, Fungicide, and Rodenticide Act. Similarly, and
for the same reasons, the definition of "imminent hazard" is brought
in line with the definition of that term in the Federal Insecticide,
Fungicide, and Rodenticide Act.

Mr. President, I am convinced that consistency is a desirable goal in
the regulation of the use of chemical substances. Since my amendment
would not in any way weaken the Administrator's authority in regu-
lating those uses, I urge that the amendment be adopted.

Mr. President, the rules state, specifically rule XXY states, that
all legislation relating to agriculture and agricultural chemistry
should be within the jurisdiction of the Agriculture Committee. To
that end kgislation having to do with FIFRA, the Federal Insecticide,
Fungicide, and Rodenticide Act, having to do with pesticide legisla-
tion has always gone to the Agriculture Committee.

This bill, however, was not referred jointly to the Commerce and
Agriculture Committees. I believe that the Agriculture Committee, if
it had had the bill referred to it, would have made as its main con-

233

tribution the reconciling of the rules with respect to the application of
the rules ^roverning the toxic substances to the FIFRA legislation so
that the EPA, in administering two a ery closely related acts, would
not have different definitions in connection with their enforcement.

All this amendment does is to conform the definitions in the toxic
substances bill to the established definitions under the FIFRA legisla-
tion which has served the EPA well and under which it now operates.

I believe the amendment is satisfactory to the manager of the bill.
I have discussed it with him, and I am hopeful that he will endorse
the amendment

Mr. Tux NET. The Senator from Alabama has, in my view, stated the
situation correctly, that his amendment is merely an amendment which
makes the language in this legislation conform with the Pesticides
Control Act as it relates to the imminent hazards, and I think it is
important that we do have on the statute books language such as the
Senator from Alabama has suggested.

Mr. Talmadgk. I commend the Senator from Alabama for intro-
ducing his amendment, and I commend the distinguished manager
and his counterpart, the Senator from Kansas, for accepting it. I
think it is important to have toxic substances and pesticides measured
by the same yardstick. That is what the Senator's amendment would
do.

Mr. TuNNEY. I thank my friend from Georgia, and I agree with his
statement. I think we should have the same yardstick in various
statutes.

Mr. Pearson. Mr. President, we find the amendment conforming
and we accept it.

The Pr?:sii)ing Officer. The question is on agreeing to the amend-
ment of the Senator from Alabama.
The amendment was agreed to.

Mr. Nelson. INfr. President, I send an amendment to the desk and
ask for its immediate consideration.

The Presiding Officer. The clerk will report the amendment.

The second assistant legislative clerk proceeded to read the amend-
ment.

The amendment is as follows :

On page 64, line 13 [Sec 10], insert immediately after the period, "In accord-
ance with s\uh responsibilities, the Administrator shall undertake and supi)ort
programs of research and monitoring of polyehlorinated biphenyls to the extent
necessary to develop safe methods of disjjosal of polyehlorinated biphenyls and for
the control of risks of injury to health or the environment associated with poly-
chh)rinated biphenyls,"

On page 52, between lines 2 and 3 [Sec. 6], insert the following new subsection :

"(e) I'oLYCiiLORiNATED BIPHENYLS. (1) Effective 1 year after the date of
enactment of this Act, it shall be unlawful to manufacture, process, distribute
in connnerce. or use any polyehlorinated biphenyl in any manner other than in
a totally enclosed manner, except that the Administrator may, by rule promul-
gated in accordance with subsection (o){2), authorize the manufacture, proc-
essing, distribution in commerce, or use of any polyehlorinated biphenyl in other
than a totally enclosed manner if the Administrator finds that no unreasonable
risk of injury to health or the environment is presented.

"(2) Effective 2 years after the date of enactment of this Act, it shall be
unlawful to manufacture any polyehlorinated biphenyl, and effective 21/2 years
after such date, it shall be unlawful to process or distribute in commerce any
polyehlorinated biphenyl, except that the Administrator may authorize, by rule
promulgated in accordance with subsection (c) (2), such manufacture, processing,

79-313 O - 77 - 16

234

or distribution in commerce after such time period if the Administrator finds
that no unreasonable risk of injury to health or the environment is presented.

"(3) Within 6 months after the date of enactment of this Act, the Adminis-
trator shall promulgate rules under subsection (a) which shall (A) prescribe
methods for the disposal of poly chlorinated biphenyls in accordance with the
requirements of that subsection and (B) specify the manner in which poly-
chlorinated biphenyls shall be marked with clear and adequate warnings and
instructions with respect to their processing, distribution in commerce, use, or
disposal. Any such rules shall be consistent with the requirements of paragraphs
(1) and (2) of this subsection or rules issued thereunder.

"(4) For the purposes of this subsection, the term 'totally enclosed manner'
means any manner which will ensure that any leakage of a polychlorinated
biphenyl from its enclosure will be insignificant, as defined in rules of the
Administrator."

On page 71, line 13 [Sec. 151, immediately following "5" insert "or 6."

Mr. Nelson. Mr. President, this amendment provides over a period
of time the elimination of the use in open or closed systems of PCB's,
polychlorinated biphenyls, unless the EPA administrator finds that
there is not a serious health hazard.

He also has to weigh, of course, under the provisions of the statute,
the question of cost-benefit ratio.

It is my understanding that the manager of the bill and Senator
Pearson are acquainted with the proposed amendment and find it
acceptable.

Mr. President, it has become clear that PCB's present a serious
pollution problem.

Therefore, I am offering this amendment.

First. It bans the manufacture, processing, distribution and use of
nonenclosed PCB's 1 year after enactment, \mless the Administrator
of the Environmental Protection Agency — EPA — finds there is no
tnireasonable risk of injury to health or environment from continuing
such uses. These include: uses in carbonless paper, paints, coatings,
soaps, and copying ink toners.

Second. The manufacture of all PCB's would be banned effective 2
years from the date of enactment ; and the processing and distribution
of all PCB's would be banned 6 months after that— 21/2 years after
enactment — unless the administrator finds that no reasonable risk of
injury to health or the environment is presented by PCB's. This would
effectively ban all PCB use, including closed uses, such as in electrical
capacitors and transformers.

Third. Within 6 months after enactment, EPA is required to issue
regulations for the first, disposal of PCB's and second, labelling Avith
warnings and instructions of all products containing PCB's with
respect to their use and disposal.

Fourth. The amendment defines "totally enclosed manner" so as to
insure that "any leakage of a PCB from its enclosure will be insig-
nificant, as defined in rules" by EPA.

All imported PCB's would be subject to the same restrictions.

This amendment is patterned after one that I introduced on Decem-
ber 19, 1975, which Senator Bumpers joined in sponsoring.

Under the. amendment, the continued use of PCB's would be allowed
if the EPA Administrator finds that "no unreasonable risk of injury
to health or the environment" exists. In making such a finding, it is
implicit that consideration be given to the availability of substitutes
for PCB's, presumably having less risk.

235

In addition, to the extent that PCB's continue to be authorized for
use, it is assumed that EPA Avill regulate any recycling of them.

Mr. President, scientific evidence makes it imperative that we no
longer wait to regulate and eliminate this toxic substance. The risks
to human health and the environment appear to exceed the benefits of
these substances, which, like DDT, are not readily biodegradable and
tend to accumulate in the food chain.

According to a report on PCB's prepared by the Legislative Re-
search Service, Library of Congress :

PCBs have been used extensively in industry for a variety of applications for 45
years. Until the mid Sixties, it was not fully recognized that large amounts of
PCBs were escaping into the environment and that the substance might cause
hazard to human health and the environment. High levels of PCBs are now found
in carnivorous fish taken from the Great Lakes and some other areas. Levels are
so high, in fact, that serious doubts have been raised over the safety of humans
consuming these fish. Sports fishing programs, such as the Coho Salmon restock-
ing projects in the Great Lakes and the commercial fishing industry in these areas
are at stake. PCBs are found at low levels in human adipose tissue in all parts of
the country, illustrating how pervasive and widespread the pollution has become.

"Although Monsanto, the sole United States producer of PCBs, has voluntarily
limited PCB sale to a few companies for use in electrical closed systems, the
problem of more PCBs entering the environment through these routes, from exist-
ing equipment containing PCBs, and from imported stocks, still exists. It has
been suggested that PCB use be totally eliminated in the United States, or al-
ternately, that its use be more tightly controlled.

The Library report further notes :

The possibility of adverse effects upon human health from PCBs was high-
lighted in October of 1968. In the Fukuoka prefecture in western Japan, acci-
dental contamination by PCBs of edible rice-bran oil caused an outbreak of toxic
symptoms, the "Yusho" poisoning incident. Soon afterward. PCBs were detected
by the U.S. Food and Drug Administration (FDA) in milk, poultry, and other
foods due to accidental leakage of PCBs from machines and PCB food packag-
ing made from recycled paper, and in fish exposed to PCBs in the environment.

Action (tolerance) levels for PCB contamination of food. feed, and food pack-
aging were established by FDA. The EPA initiated a test program and moni-
toring of PCB levels in the environment and proposed regulations governing the
discharge of PCBs into waterways as an industrial effluent (under the Clean
Water Act). Meanwhile, on the state level, actions were taken against point
source discharges of PCBs.

The widespread occurrence of PCBs in the environment, the bioaccumulation
of PCB in the food chain of fish found in the human diet, and the persistence of
the chemical compounds assure that PCB environmental contamination will con-
tinue to be a problem for many years to come.

Here are the facts :

PCBs have been found, in scientific tests, to cause severe skin and liver prob-
lems in humans. University of Wisconsin Medical School researchers Dr. James
R. Allen and Deborah Barsotti. have demonstrated that very low PCB levels are
dangerous to primates, causing facial swelling, loss of hair, acne lesions within
one month, birth defects, miscarriages, stillbirths, and death.

A 1972 report by a Federal interdepartmental task force urged a ban on all
PCB uses except in closed electrical systems, restricting them to "essential or
nonreplaceable uses which involve minimum direct human exposure, since they
can have adverse effects on human health."

The commercial fishing industry in the Great Lakes and elsewhere are threat-
ened with extinction, unless the PCB problem can be alleviated or eliminated.
Thousands of pounds of Great Lakes fish have been condemned as unsafe because
of PCB contamination, and New York State conservation officials warn against
eating Hudson River fish.

Water supplies throughout the Nation are contaminated far in excess of safe
drinking criteria.

236

There has not been adequate monitoring of the extent of the pollution, nor of
the sources of the pollution.

At least 10 million pounds of PCBs are lost into the environment each year
through vaporization, leaks, and spills, according to estimates reported by Thomas
E. Kopp, a chemist with the EPA's Office of Toxic Substances.

At least 10 plants are dumping PCBs into U.S. waterways and another two
are discharging the chemicals in municipal sewage treatment systems, according
to the EPA.

PCBs have been banned for most uses in Japan — after the 1968 poisoning of
more than 1,000 persons who had eaten PCB-tainted rice cooking oil.

Alternatives have been instituted in Japan, and are being developed in the
United States. For example, air-filled transformers have been used for years in-
stead of PCB-filled transformers.

Use of alternatives to PCBs may require retooling and redesigning of some
electrical products and equipment which now use PCBs.

PCBs are used in about 5% of all transformers and in almost all industrial
capacitors in the United States.

PCBs can be destroyed in special incinerators at very high temperatures.

PCBs can be recycled.

There is no dispute over their toxicity to wildlife and to humans.

This amendment would allow time for the phasing out of the manu-
facture and use of PCB's over years.

It is preferable not to enact legislation on a substance-by-substance
basis but rather generically, as the Toxic Substances bill proposes to
do. However, the PCB problem shows no sign of abating and it has
become so severe that it is necessary to address the problem head on, as
we were forced to do with DDT.

Mr. President, I ask unanimous consent to have printed in the Eec-
ord three articles illustrating the extent of the problem and the com-
mercial impact on the Great Lakes fishing industry as well as in New
York State, as a result of PCB pollution in the Hudson River and
Lake Ontario.

There being no objection, the articles were ordered to be printed in
the Record, as follows :

[From Wisconsin Natural Resources, January/February 1976]
Sources of Polychlorinated Biphenyls in Wisconsin

Wisconsin's interest in PCBs began in the late 1960's when interfering sub-
stances were detected in fish being tested for DDT. Later we were to learn these
interfering substances were PCBs.

In 1970, the Department collected fish samples along the Mississippi River
bordering Wisconsin. Analysis revealed that between Prescott and Pepin fish
commonly exceeded the Food and Drug Administration (FDA) tolerance level
of 5 parts per million (ppm). During 1971, Lake Michigan fish were collected and
later tested. Mean concentrations of PCBs in these fish ranged from 2.7 ppm in
smelt to 15 ppm in lake trout. Subsequent studies confirmed the presence of
PCBs in fish in Lake Michigan and other waters of Wisconsin.

The search for PCBs in water was also underway at this time. An analysis of
water from the Milwaukee River indicated that PCBs were present from West
Bend to Lake Michigan and being discharged through municipal and industrial
effluents. In 1971, eleven municipal wastewater treatment plant effluents in Wis-
consin were sampled and nine contained PCBs. Studies of the Cedarburg waste-
water treatment plant indicated that more than 70 percent of the PCBs coming
into the plant were removed during the treatment process and comparatively
high concentrations were found in the digester and primary settling sludges.

The Department surveyed many municipal wastewater treatment plan effluents
in Wisconsin from 1972 through 1974. PCBs were detected in concentrations ex-
ceeding .05 parts per billion (ppb) in more than half of those tested even where
there were no suspected industrial sources. In most cases, the discharge was well
below 1 ppb and .01 ponds per day. However, higher concentrations were found
in effluents from industrial areas.

237

Tracing sources of PCBs reaching a large municipal wastewater treatment
plant is difficult and time consuming. The Department is attempting to trace
sources of PCBs reaching treatment systems where the final effluent exceeds 1
ppb. At present we know of only two municipal wastewater treatment plants in
Wisconsin which exceed 1 ppb — Sheboygan and Portage.

Main source of PCBs at Portage was found to be a facility that had used
PCBs in the manufacture of carbonless copy papers prior to the summer of 1971.
After ceasing the use and after repeated cleanings of holding tanks the dis-
charge was substantially reduced. Residuals still remain, however, in the sewer
system and the sewer sludges, resulting in an effluent of several ppb at the munici-
pal sewage treatment plant. We are continuing to check sources of discharge at
Sheboygan.

The Department has checked effluents from iron and steel foundries and alu-
minum foundries. Cooling water effluents from five of seven aluminum foundries
contained PCBs ranging from 11.5 to 335 ppb. Close investigation revealed the
common source to be leaking hydraulic fluids used in die cast machines. We are
working with company officials to correct this. PCBs have been found in the cool-
ing water effluent of only one of nine iron and steel foundries checked to date and
that at a concentration of .9 ppb.

DNR has tested effluents of 17 pulp and paper mills. Nine mills which recycle
wastepapers had measurable discharges ranging from .1 to more than 25 ppb.
Mill representatives indicate that the paper industry no longer uses PCBs and
those found in wastepapers come primarily from carbonless copy papers which
were produced prior to 1972. The old carbonless copy papers were widely used in
forms and continue to enter the wastepaper market as old files are discarded.
Because their solubility in water is low. we believe that most of the PCBs dis-
charged from wastepaper mills are absorbed on fibers and other particulate mat-
ter. Mill wastewater treatment systems which effectively remove particulate
matter should also remove PCBs.

The electoral industry continues to use PCBs as dielectric fluids in some ca-
pacitors and transformers. Although the units are sealed some fluids may be lost
as a result of accidents or disposal practices. In March 1975, the Department
corresponded with major electrical companies in Wisconsin to determine cur-
rent handling practices. This was followed by visits to many facilities. The com-
panies contacted were aware of the problems, but some were not aware of recom-
mended Guidelines of the American National Standards Institute for handling
and disposal. We also found that some were storing defective capacitors until a
proper disposal method could be found. As a result specific guidance was given
to Wisconsin electric utilities for the proper handling and disposal.

Snow samples were collected early in 1975 to determine if PCBs were deposited
on land and water as fallout from the air. Analysis of snow melt water from
Racine. Kenosha, Madison and Milwaukee revealed concentrations from .17 to .24
ppb. These values suggest that fallout of PCBs from the air may be a principal
source of PCBs entering the waters of the state.

PCBs are present in sediments in harbors and streams near industrial areas.
The sediments act as a reservoir from which PCBs may be released slowly over
a long period of time. Sediment samples have tested 3.5 ppm in the Milwaukee
River near the Capitol Drive Bridge, 9 ppm in Superior Harbor, and 72 ppm in
the Fox River below the outfall of the Portage sewage treatment plant.

We have tried to work out a materials balance for PCBs entering the environ-
ment using the domestic sales figures provided by the Monsanto Company and
other data. So many pieces are missing from the puzzle, however, that these
efforts have been unsuccessful. However, some general comments can be made.

1. PCBs have been sold by the Monsanto Company for more than 45 years. The
company reported domestic sales of 795 million pounds from 1957 through 1974.
In 1974 Monsanto's domestic sales were reported to be 34 million pounds for use
in closed electrical systems. In addition, the Office of Toxic Substances EPA has
reported that foreign sales of PCBs in the United States in 1974 exceeded
375,000.

2. The PCB problem in Wisconsin is a fishery problem caused because residues
have accumulated in certain fish in Green Bay and Lake Michigan and the Upper
Mississippi River in excess of the FDA tolerance level of 5 ppm. Laboratory ex-
periments have shown that fish accumulate PCBs more than 100,000 times levels
present in the water. Therefore, even parts per trillion (ppt) levels have signifi-
cance to the fishery resource.

238

3. Our data indicates that levels of PCBs in fish in the Upper Mississippi River
have declined in recent years. We have not detected a corresponding decline in
levels in Lake Michigan fish.

If Lake Michigan water contains an average of 10 ppt PCB then there are
more than 100,000 pounds in solution and probably a much larger poundage in
the sediments. We have tested the major effluents of both municipalities and in-
dustries discharging to the Lake Michigan drainage in Wisconsin and estimate a
discharge of about two pounds per day or 730 pounds of PCBs per year to Wis-
consin's drainage to Lake Michigan. Most PCBs identified in our testing of
major effluents occur in the wastewaters of pulp and paper mills which recycle
wastepapers.

Discharges of PCBs from pulp and paper mills, which recycle wastepapers, will
diminish as the mills meet discharge permit requirements. Wisconsin mills
which recycle wastepapers are required to reduce discharge of suspended solids
from 131,000 pound per day (for calendar year 1973) to 45,000 pound per day
by the 1977 compliance date. Recently one mill in the state, which uses only re-
cycled paper, began a new treatment system that has reduced the discharge of
suspended solids from 40,000 pounds per day to 3,000 pounds. Tests at this facility
revealed 39 ppb PCB entering the treatment system with only 1 ppb being dis-
charged in the final effluent.

4. In our search for sources of PCBs entering the environment, we have not
looked closely enough at fallout from the air. Our testing of snow melt suggests
that fallout may be contributing much greater amounts of PCBs than are being
contributed by industrial and municipal effluents. Trace concentrations in fallout
over Lake Michigan and its watershed which cover 67,900 square miles could
result in appreciable amounts entering Lake Michigan.

Because PCBs are stable compounds with low vapor pressures, little loss is
expected to occur through vaporization from disposal sites where capacitors
and other equipment and materials have been disposed and covered with over-
burden. Entry into the air may be expected to occur at locations where papers
are incinerated, at foundries where imported casting waxes containing PCBs
are heated to high temperatures and at manufacturing facilities. PCBs adsorbed
on fine particulate matter may also be entering the air as windblown dust.

5. Further information is needed to define the amount contributed to Lake
Michigan and other waters through past accumulation in sediment. A University
of Wisconsin study is currently underway in Southern Lake Michigan, which
should proA'ide some answers.

DNR does not have the authority to regulate the sale or use of PCBs, but can
adopt affluent standards.

In December the Natural Resources Board voted to severely limit PCB dis-
charge. This action will be reviewed by the state legislature before it can become
effective. The board also proposed legislation that would limit the sale and use
of PCB's in Wisconsin.

[From Bulletin of the Lake Michigan Federation, January-February 1976]
PCBs Cost Jobs, Too
(By Elizabeth Botts)

Consumers aren't the only victims of PCB contamination in Great Lakes fish
and waters. Fishermen had their livelihoods abruptly cut off when the Food and
Drug Administration issued a ban on their contaminated produce last August.
A group from Green Bay, Wisconsin, reported to the Federation that they plan
to make their grievances publicly known.

Mrs. James Hermes, of Green Bay, wrote to the Federation last October to
ask for help in stopping the sources of PCB pollution in her area. "As long as
little is done to stop the source, not merely the result," wrote Mrs. Hermes,
"many more will suffer."

But stopping the sources is a generous impulse that will help others, nor the
Hermes family. "If PCB discharge is stopped, then how do we clean up the
existing poison they have left with us?" she asked. "I'm sure the industries won't
volunteer. They have gotten rich at everyone's expense but their own.

Although there is growing concern in various government agencies on the effects
of PCBs, the FDA is presently the only Federal agency with authority over
their use, and can only ban contaminated wildlife that are harvested and proc-

239

essed for food consumption. That's why the Hermes' fisheries and other small
fishing businesses like them were the only ones to suffer a federal injunction
against their fishing activities. The sources of the Lakes' PCBs. e.g.. paper-
recycling mills, are free from penalties.

The Hermes are fourth-generation commercial fishermen. Ever since Jim
Hermes' great-grandfather came to Wisconsin from Germany, before the turn of
the century, the family has been sailing out of Green Bay. Xow there are two
Hermes fisheries. Jane and Jim Hermes caught Lake Michigan carp and shipped
them to Missouri as stock for private and municipal fishing ponds in and arouud
St. Louis. Jim's cousin, Lee, and his wife. Glory, sold to canneries around Green
Bay. Then, without warning, both groups were ordered to stop working.

Not only could they not sell their fish, the St. Louis municipal authorities had
to poison all sj^ecies of fish in the city's private and public fishing iK)nds to be
sure of removing the Hermes carp.

Lee Botts. then Federation Director, responded to Mrs. Hermes appeal, by ar-
ranging for both Hermes families to attend the National Technical Conference on
I'CBs organized by the EPA and other Federal agencies and held in Chicago
last November. They told their story at the conference and on WGN-TV, pointing
out that even if a ban were imposed immediately it would be years before PCB
levels in fi.sh went down enough to permit harvesting.

Things don't look good for the Hermes family. "We don't know what we're going
to do," says Mrs. Hermes. "My husband and his cousin are going to try to work
on some of the inland lakes where the PCB levels are low. but there aren't a lot
of fish there. I don't know what will happen." Jane and Jim have four children
and Lee and Glory have seven, so "it's quite a large family to lose their
livelihood."

The Hermes fisheries and others in the Green Bay area tried to get themselves
declared a disaster area so they would qualify for Small Business Administra-
tion loans, but the request was denied.

The Wisconsin Department of Natural Resources doesn't have a lot of help
for the Hermes either. According to Ron Poff. of the Great Lakes fishing section
of the DNR. the Wisconsin Natural Resources Board had decided to call for stiff
discharge limits and to draft legislation for a total ban on manufacture and
sale of PCBs. but neither of these measures — if they are carried out — will be
effective until 1977. There are powerful interests, including the Wisconsin Paper
Council, who can be expected to oppose them. "Considering what paper means in
Wisconsin," Poff says, "it's preitty substantial action. And it's the onlv action
we c-an legally take."

The only immediate help the DNR can offer to Green Bay fishermen is to look
for areas where levels may be low enough to allow harvesting. Poff savs a few
fisheries are already back at work on the Bay's far western edge.

Still, it's probably too late for the Hermes, though Mrs. Hermes hasn't lost
her anger or her determination. She's circulating a i)etition calling for a ban on
PCB discharge, and hopes that this is one issue on which the sports and com-
mercial fishermen of Lake Michigan can get together.

The Hermes have retained a lawyer and are investigating the possibility of a
lawsuit, but "there are so many dumping we wonldn't know where to start "
And despite her hopelessness over her own situation, Mrs. Hermes still believes
that something can be done about PCBs in Lake Michigan.

"It's too late for us," she says now, "but maybe it won't be too late for some
others.

[From the American Medical News. Mar. S. 1976]
PCB Discovery Leads to Fisn Bax

Polychlorinated biphenyls (PCBs) from indus?trial pollution have contaminated
fish HI the Hudson River and Lake Ontario. As a result. New York State has
banned commercial fishing in the Hudson, and advised sportsfishermen to restrict
their consumption of fish caught in these waters. The ban does not include shad ;
analysis of these fish have shown low PCB levels.

The FDA has set a ceiling of 5 parts per million (ppm) as the limit of PCB
permissible in fish to be consumed by humans. PCBs cause an acne-like skin
eruption, pigmentation of the skin and nails, excessive eve discharge, and
swelling of the evelids.

240

FDA has found PCB levels as high as 31.3 ppm in fish caught in the Hudson
and 24,6 ppm for salmon from Lake Ontario.

Mr. TuNNEY. Mr. President, I have had the opportunity to look at
this amendment. It was submitted by the Senator from Wisconsin
yesterday. I commend him in his efforts to control the hazards asso-
ciated with the PCB's. We know how dangerous they can be.

I think the Senator's amendment strengthens the legislation and I
am prepared to accept it for both minority and majority on the Com-
merce Committee.

Mr. President, I commend the distinguished Senator from Wiscon-
sin on his efforts to control the hazards associated with PCB's. PCB's
have long been of concern to the Committee on Commerce as evidenced
by hearings held on the subject by the Subcommittee on the Environ-
ment last October 24.

Those hearings documented the fact that despite assurances from the
sole domestic manufacturer of PCB's, they are still escaping into the
environment in awesome quantities, in fact some 10 million pounds per
year. Although an agreement several years ago by the Monsanto Co.
supposedly retricted PCB's use to closed systems, ^Monsanto obviously
has no control over those to whom it sells PCB's nor does Monsanto
have any control over those who import PCB's. Thus, PCB's are still
being used for nonclosed system uses.

At the same time, PCB's have been shoAvn to cause cancer in one
study, and to interfere with reproduction.

In my view, the amendment of the Senator from Wisconsin is indeed
appropriate. It phases PCB's out by eliminating nonclosed system uses
within 1 year and eliminating PCB's altogether within 2 years. There
are mechanisms for authorizing uses of PCB's beyond these time limits
should that be appropriate so that we do not create worse problems
than those we solve.

In my view, the amendment is a fine addition to the bill, and I urge
its adoption.

The Presidixg Officer. The question is on agreeing to the amend-
ment of the Senator from Wisconsin.
The agreement was agreed to.

Mr. Canxox. Mr. President, I send an amendment to the desk and
ask for its immediate consideration.

The Presiding Officer. The amendment will be stated.
The second assistant legislative clerk read as follows :

The Senator from Nevada (Mr. Cannon) proposes an amendment :
On page 36, line 17, [Sec. 6(a)(1)], insert the following:

After the word "risk,"' insert a comma and the words "using the least burden-
some effective controls."

Mr. Canxox. Mr. President, I ask unanimous consent that Senator
Johnston be included as a cosponsor.

The Presidixg Officer. Without objection, it is so ordered.

Mr. Caxxox. Mr. President, this is simply a clarifving amendment
to be sure that the administrator does use the least burdensome effec-
tive procedure. I hope the Senator will be willing to accept it.

Mr. Beall. Mr. President, I rise to support S. 3149, the Toxic Sub-
stances Control Act, and hope that the Senate will oive its overwhelm-
ing endorsement to this measure.

241

Twice before, in 1972 and 1973, the Senate passed toxic substances
legislation, only to be frustrated in our efforts to reach acrreenient with
the House of Representatives on this matter. This year, however, indi-
cations are that chances for Senate-House agreement are good, and
thus we will be able to place a strong toxic substances bill on the Presi-
dent s desk prior to adjournment of the 94tli Congress.

I can think of no more pereuasive argument in favor of this legisla-
tion than the stories which have appeared almost daily in the press
regarding the serious chemical hazards now present in our environ-
ment. In recent months, we in this country have become painfully
aware of the catastrophic long-term effects that such chemicals as ke-
pone, vinyl chloride, mercury, and PCB's may have on humans. In
fact, approximately 1,000 new chemicals are marketed each year, to
find their way into' our environment. These chemicals need to be pre-
tested before' they enter the market, and this bill accomplishes that
purpose in a reasonable and responsible manner.

The committee has also made great efforts in this legislation to bal-
ance the health needs of our people with economic realities. Through-
out the bill, the Administrator of the Environmental Piotection
Agency is required to fully consider the reasonably ascertainable eco-
nomic effects of his actions and publish them for the public record.

Mr. President, the terrible effects of toxic chemicals are often not
evident until many years after initial exposure. Russell Train, Admin-
istrator of the EPA, recently pointeii out that Americans were, with-
out either their knowledge or consent, often engaging in a grim game
of chemical roulette. This legislation seeks to end that game, which
can have no winners, and I urge the Senate to give its strong support
to this much-needed and long-awaited legislation.

Mr. TrxxEY. Mr. President, I have had an opportunity to review
the amendment that is being offered by the Senator from ?s^evada and
I would like to ask him a question with respect to it.

If the Senator's amendment is agreed to and is made a part of the
law, unreasonable risks must still be prevented and protected against,
must they not?

Mr. Caxnox. Is the Senator talking about the amendment we just
acted upon or the other amendment we are considering ?

Mr. TuNNEY. I am talking about the amendment the Senator offered,
aft^r the word ''risk," insert a comma and the words "using the least
burdensome of effective controls.''

The Presidixg Officer. The Chair advises the Senator, that is the
pending amendment, it is now pending.

Mr. Caxxon. Yes; the answer to the Senator's question is ''Yes."

Mr. TuNXXY. Fine.

Then under those circumstances. I do not see any reason at all that
this amendment should not be accepted. I feel that as long as it is very
clear in the Record that unreasonable risks must still be prevented
under the regulatory framework, certainly it would be important to
use the least burdensome of effective controls to effectuate that desired
result.

So I accept the amendment.

Mr. Pearsox'. Mr. President, it is my understanding the effective
control is still the essentiality of what the Administrator will do.

242

Mr. Cannon. Yes.

Mr. Pearson. And this amendment just seeks the least burdensome
procedure to get there ?

Mr. Cannon. The Senator is correct.
Mr. Pearson. I find it acceptable.

Mr. Cannon. We do not want to give the Administrator unlimited
authority and let him say, "I will impose this control," if there are
other controls that are effective and are less burdensome on the
industry.

That is really what is intended.

The Presiding Officer. The question is on agreeing to the
amendment.

The amendment was agreed to.

Mr. Cannon. Mr. President, I send an amendment to the desk and
ask for its immediate consideration.

The Presiding Officer. The amendment will be stated.
The second assistant legislative clerk read as follows :

The Senator from Nevada (Mr. Cannon) for himself, Senator Laxalt, and
Senator Johnston proposes an amendment :

On page 5, line 2, [Sec. 6(d)(2)] after "(3) insert "in those situations where
compliance with the requirements of subsection (c) (2) or (3) would present
an unreasonable risk of death, serious or substantial personal injury (including
illness) or serious or substantial environmental harm."

Mr. Cannon. Mr. President, in the Commerce Committee several
members expressed concern that a provision in the bill authorizing
the Administrator to make rules regulating chemical substances im-
mediately effective was too broad. Efforts Avere made to narrow that
authority to those situations Avhere the public interest required, and an
existing provision in the Administrative Procedure Act was referenced.

Unfortunately, the language in the APA is somewhat ambiguous and
could be interpreted to permit the EPA Administrator to waive the
due process requirements of the rulemaking provisions at whim. That
certainly was not the intent.

Therefore, this amendment that is submitted is perfecting the
language of section 6(d)(2) of the bill.

The perfecting language prohibits the Administrator from waiving
the due process requirements of section 6 rulemaking unless compli-
ance would present an unreasonable risk of serious or substantial in-
jury to health or the environment. This limits the authority to put
rules into effect quickly to those cases where there is real need to pro-
tect the public health or environment immediately and I think car-
ries out better the intent of the Committee and particularly my intent
in offering the original amendment in committee.

I Avould hope that the amendment Avould be agreed to, Mr.
President.

Mr. Hartke. Mr. President, let me say about the amendment sub-
mitted by the Senator from Nevada that I think this amendment should
be satisfactory to the committee and also to the manager of the bill.
This Avas the heart of a lot of discussion in the Senate Commerce Com-
mittee. I think the Senator from Nevada has correctly stated the situa-
tion. We want to make sure that the Administrator has the authority ;
we want to make sure that due process is protected ; we Avant to make
sure that there is not an unreasonable delay in absolute prohibition in
case it needs to be done.

243

On the other side of the coin we wanted to make sure there was not
some type of arbitrar}^ decision by the Administrator. I believe the
amendment by the Senator from Nevada does carry out the intent of
the committee at the time. We had long discussions about this matter.
I do thing possibly it could be misinterpreted or be ambiguous in the
way it was originally drafted.

Mr. TuxxEY. I want to thank my friend from Indiana for that ex-
planation. I am impressed by his comments, and by what the Senator
from Nevada said.

I would like to ask the Senator from Nevada a question. What is
meant by serious and substantial personal injury as it is contained
here, or serious or substantial environmental haiTQ ?

Mr. Cannon. A ''serious'* illness would be one causing a high degree
of illness to a relatively small number of people whereas a substantial
illness would be one involving a lesser degree of illness but affecting a
large portion of the population.

Mr. TuNNEY. I have no objections to the amendment and I am pre-
pared to accept it. I am authorized to accept it for the minority.

The Presiding Officer. The question is on agreeing to the
amendment.

The amendment was agreed to.

The bill is open to further amendment. If there be no further amend-
ment to be proposed, the question is on the engrossment and third
reading of the bill.

The bill was ordered to be engrossed for a third reading and was
read the third time.

Mr. Thurmond. Mr. President, I have received numerous letters
from companies operating in my State, and some out of the State,
concerning this bill.

I would like to call to the attention of the Senate a few of these
letters.

Certainly, I w^ant to take every step possible to protect our people,
but it appears that this bill goes further than necessary.

I have a letter in my hand from ^filliken Chemicals, which I would
like to read into the Record.

The Toxic Substances Control Act is probably the most serious threat the chem-
ical industry has ever faced. This bill could require that before any chemical is
sold, even in research quantities, it be subjected to all the tests required of a new
drug.

The tests that could be required would easily cost $100,000 and. in many cases
much more. The authority to determine just how many tests and what tests would
be run will reside with the administrator of the EPA. While it is possible that a
reasonable administrator would not be too severe, it is undesirable to have the
welfare of one's business hang on the whim of an administrator. Furthermore,
according to the bill, any person may initiate a civil action for injunctive relief.
Therefore, any manufacturer is not only at the mercy of the administrator but is
also at the mercy of any citizen who has an "axe to grind".

Five reasons for you to oppose this bad piece of legislation :

1. It is unnecessary : We already have 27 health and environmental laws which
cover the "toxic chemicals" that this bill would regulate.

2. It will be inflationary : It will increase the cost of production because of the
severe testing required. It will reduce the number of products available and re-
quire the use of more expensive products in many cases.

3. It will stifle progress : Unnecessary restrictions will seriously hamper the
flow of new products and we will be frozen into products we now have — some of
which products have serious limitations and which could be improved if research
and development were allowed to continue with reasonable caution.

244

4. It will drive industry overseas : Many companies will be forced to take their
research and production to other countries where laws are less oppressive.

5. It is vague. The bill gives an EPA Administrator very broad authority with
very few restrictions.

6. It probably won't work. Even one who supports the bill admits, "this bill
will not, of course, catch all of the dangers. Some of the adverse effects occur in
such unique circumstances or after very long times (up to 20 years in some
cases) that it would be extremely diflBcult to diagnose their dangers. Very long-
term testing would be very costly to industry and would seriously delay use of
some valuable new chemicals." The logic here is inescapable.

This bill will have a serious effect throughout industry. Even those who use
specialty chemicals or buy products that require specialty chemicals in their
manufacture will have problems.

The large companies may be able to meet the excessive costs and red tape in-
volved but it is bound to increase their costs. It is questionable if the small com-
pany can survive.

I appeal to you to seriously consider the reasons outlined in this letter and
put the face of your oflSce behind the effort to defeat this proposed legislation.
Sincerely,

C. M. Butler,
General Manager.

Mr. President, I have another letter here from a smaller company,
the Graniteville Co. in Graniteville, S.C. It reads:

Dear Senator Thurmond : I am writing you about my deep concern over the
Toxic Substances Control Bill that is presently in the final draft stage of the
Senate and House Subcommittees. It is quite evident that if the Tunney Bill is
passed in its present form, many chemical companies, both large and small, could
possibly be out of business in short order. The textile industry has had to wrestle
with many new government regulations in the last few years, many of which have
been most beneficial, while others have taxed the sanity of most corporate
management.

As I am sure you are aware, Graniteville Company has had a small wholly-
owned subsidiary which manufactures dyes and chemicals. This Bill would re-
quire a ninety-day notice for manufacture or import of new chemicals, a ninety-
day notice on change in formulations or on new uses of existing chemicals, and
has broad powers to stop the manufacture of any chemical or finished product.
In addition, the cost of testing each new chemical would approximate $100,000 to
$300,000 and would increase the operating costs of our subsidiary by millions of
dollars if this law were strictly enforced. I strongly believe that almost every
business has worked closely with and survived OSHA, EPA and other govern-
ment agencies, but we cannot survive if this Bill is passed and enforced in its
present form.

Mr. President, those letters are typical of others I have received, and
I ask unanimous consent that a number of additional letters be printed
in the Record following these.

There being no objection, the letters were ordered to be printed in
the Record, as follows :

Monsanto Textiles Co.,
Greenwood, S.C, J,anuary 19, 1976.

Hon. Strom Thurmond,
U.S. Senate,
Washington, D.C.

Dear Senator Thurmond : As manager of Monsanto's plant in Greenwood, I
want to express my strong opposition to the all-encompassing nature of toxic
substances legislation currently being considered by committees in the Congress.
The bills could seriously impact 2100 people, engaged in the manufacture of
nylon at our Greenwood location, plus another 278 Monsanto employes working
elsewhere in South Carolina.

I do support appropriate legislation on toxic substances for the pubhc's wel-
fare, but the pending bills (S. 3149 and H.R. 10318) are overly burdensome to
industry and detrimental to the public interest. It seems to me that this is an-
other example of the overregulation which concerns us all today.

Specifically, the bills could impose costly and unnecessary testing requirements,
on new and existing chemical substances without regard to the risk which may
be involved. They also require regulations on the manufacture and use of sub-

245

stances, based on the mere possibility of an unreasonable risk, without requiring
an economic impact statement, even though the rules could ban production, shut
down plants, and terminate jobs. Uncertainty in enforcement would occur since
duplicative actions by different Federal agencies are encountered.

These defects can be corrected. A bill which meets many of these concerns has
been introduced by Rep. John McCollister, H.R. 7664). I urge you to actively sup-
port legislaticni like the McCollister bill, and work against bills which threaten
entire industries and payrolls with needless over-regulation. I hope you will also
voice your concern to committee members now considering toxic substances bill.

Congratulations on again becoming a proud father. I know Nancy got first
class treatment at the hospital here and your son was very photogenic !
Sincerely,

R. T. Phelps, Jr.,

Plant Manager.

Exxon Chemical Co., U.S.A.,
Summerville, 8.C., January 22, 1976.

Hon. Strom Thurmond,

U.S. Senate, Senate Office Building, Washington, D.C.

Dear Senator Thurmond : As a follow-up to my telephone call of today to Mr.
John Steer, I would like to set forth in somewhat more detail my company's
concerns regarding the Toxic Substances Control Legislation (S. 3149) (H.R.
10318) now before the Senate (House).

We support appropriate legislation in this area but are convinced that this bill,
if enacted, would be overly burdensome (particularly to the small companies
which compri.se the bulk of the chemical industry), would unnecessarily increase
costs, would stiffle innovation and, ultimately, would make the U.S. chemical
industry much less competitive than its strong counterparts in Europe and
Japan.

This legislation could impose costly and unnecessary testing requirements
with resi)ect to new and existing chemical substances, in many cases without re-
gard to tlie relative level of risk which may be involved. It requires the promul-
gation of rules governing the production and use of chemical substances on the
mere i)Os.sibility that these substances may present an unreasonable risk. It
doesn't even require the preparation of an economic impact statement although
the regulations could l>an the production of a chemical, shut down the plants
making it or using it, and terminate the jobs involved. The bill would also create
uncertainty in the enforcement of Federal laws by encouraging duplicative ac-
tion by different Federal agencies and would permit the EPA to pick and choo.se
among potentially applicable laws.

My company believes that a law as broadly drawn as this would be, giving
vast powers to the Administrator of the EPA without his being required to con-
sider and weigh the economic con.sequences of his actions, is neither necessary
nor appropriate to control toxic substances. In our view, appropriate legislation
is exemplified by H.R. 7664, which has been introduced in the current Congress
by Rep. John McCollister. It is similar to a bill passed by the Hou.se in the last
Congress and provides adequate means of controlling toxic .substances without
needless and costly overregulation. I hope you will support this kind of legislation
rather than S. 3149 (H.R. 10318) which could result in such adverse conse-
quences to industry without offering added assurance of public safety.

I am attaching a summary of some of the major concerns of the chemical in-
dustry regarding the bills now before Congressional committees, as compiled by
the Manufacturing Chemists A.ssociation. If you wish additional information,
I'll be happy to provide it.
Sincerely yours,

J. J. Jamison.

Firestone Steel Products Co.,
Spartanburg, S.C., January 19, 1976.

Hon. J. Strom Thurmond,
U.S. Senate,
Washington, D.C.

Dear Senator Thurmond : Despite the firm commitment of The Firestone Tire
& Rubber Company to the prevention of undue risk to human health and the envir-
onment at its manufacturing plants, I am deeply concerned about certain provi-

246

sions of the toxic substances control bills currently before the Committees of the

^""ourcompany supports appropriate legislation in this area, but the pending
bills (S. 3149 and H.R. 10318) are unduly burdensome to industry and could be
detrimental to the public interest for the following reasons : , . , ,

1 By imposition of costly and unnecessary testing requirements with respect to
new and existing chemical substances, in many cases without regard to the rela-
tive level of risks which may be involved ; , ^. ^

2 By requiring the promulgation of rules governing the production and use ot
chemical substances on the mere possibility that these substances may present an
unreasonable risk, without recourse to an economic impact statement ;

3 By creating uncertainty and duplication of Federal law enforcement under a
plan which permits the EPA to pick and choose among potentially applicable
statutes. . , . , ^ „ , ,

These are all correctible defects. In fact legislation which met many of these
concerns passed the House of Representatives in the last Congress. A similar bill,
H.R. 7664, has been introduced in the current Congress by Rep. John McCollister.
I urge Members of Congress to actively support legislation like the Mc(.V)llister
bill, H.R. 7664, and to work against the enactment of legislation which would
threaten entire industries with needless regulation without offering added assur-
ance of public safety.

I hope you will also voice your concern to members of the committee now con-
sidering toxic substances control bills.
Sincerely,

D. E. Oldham,
Plant Manager.

W. R. Grace & Co.,

ZONOLITE,

Enoree, S.C., January 19, 1916.

Hon. Strom Thurmond,
U.S. Senate,
Washington, D.C.

Dear Sir : As Manager of W. R. Grace & Co.'s Kearney Plant at Enoree, South
Carolina, I wish to express to you my views concerning some bills now before the
Congress.

Our plant produces vermiculite, and at present employs approximately 115 men
and women.

Despite the firm commitment of the chemical industry to the prevention of un-
due risk to human health and the environment from exposure to toxic chemicals,
we are deeply disturbed and concerned about the provisions of the toxic sub-
stances control bills currently under consideration by the Committees of the
Congress.

We support appropriate legislation in this area, but the pending bills (S. 3149
and H.R. 10318) are overly burdensome to industry and detrimental to the public
interest. They could impose costly and unnecessary testing requirements with re-
spect to new and existing chemical substances, in many cases without regard to
the relative level of risk which may be involved. They require the promulgation
of rules governing the production and use of chemical substances on the mere
possibility that these substances may present an unreasonable risk, and do not
even require the preparation of an economic impact statement, although the regu-
lations could ban the production of a chemical, shut down the plants making it or
using it, and terminate the jobs involved. The bills would also create uncertainty
in the enforcement of Federal laws by encouraging duplicative action by different
Federal agencies and would permit the EPA to pick and choose among potentially
applicable laws.

These are correctible defects. In fact, legislation which met many of these
concerns passed the House of Representatives in the last Congress. A similar
bill, H.R. 7664, has been introduced in the current Congress by Re.p. John
McCollister. We urge Members of Congress to actively support legislation like
the McCollister bill, H.R. 7664, and to work against the enactment of legislation
which would threaten entire industries with needless regulation without offering
added assurance of public safety.

247

I hope you will also voice your concern to Members of the Committee now
considering toxic substances control bills.
May I count on your help?
Yours very truly,

O. F. Stewabt,

Manager.

Fiber Industries, Inc.,

January 19, 1976.

Hon. J. Strom Thurmond,
Dirk sen Senate Office Building,
Washington, D.C.

Dear Senator Thurmond : As the Plant Manager of the Greenville Plant of
Fiber Industries, Inc., situated in Greenville, S.C.. I wish to follow up the con-
versation between Hugh RoUinson, Technical Manager and Mr. John Steer, in
expressing our opposition to S. 3149, the Toxic Substances Control Bill, in its
present form. This measure is now before the Senate Commerce Committee.

S. 3149 requires premarket testing and screening. I'm not opposed to this broad
concept. As one well versed in the chemical industry I have consistently sup-
ported legislation that would require reasonable testing and premarket screening
of chemical substances which are likely to pose a "substantiar' danger to health
and the environment. By "substantial" danger, I mean unreasonable risk of death
or severe i)ersonal injury or illness as well as widespread or severe harm to the
environment.

I am opposed to S. 3149 because I believe it would retard basic research,
the development of new products and the development of new uses for existing
products by requiring excessive and routine long term testing and premarket
screening requirements for individual chemical substances or classes or such
substances.

S. 3149 requires all new substances which "may present'' [Sec 4(a) (1) (A) (i)]
an unreasonable risk to public health be tested and screened in accordance with
E.P.A. procedures. I have earned over the year sthat testing for chronic effects
to determine the carcinogenic ix)tential of materials is long term taking two to
four years to complete with costs from $300-$750.000.

I'm not in favor of trade-off testing at the expense of safety but I do believe
that unnecessary tes*ting and screening is not only wasteful of the valuable
time of a limited number of highly qualified technicians we have in our company
but wasteful of financial resources, for these activities neither contribute to
protecting health or the environment and impede research and development.

The term "unreasonable risk" used throughout the bill and in my judgment
is too broad and needs to be strictly defined in a meaningful way as I suggested
earlier. With such a guide or standard, testing and screening would be limited to
those products presenting significant risks and the likelihood of excessive and
unreasonable testing would be minimized. In the same vein, it seems to me that
the language ''may present'' should be changed to "present" to require action
based upon fact rather than a mere possibility of fact.

I believe that toxic substances legislation should be limited to gap areas not
covered by other laws. It seems to me that S. 8149 goes far beyond the gap areas
and overlap laws such as the Clean Air Act and the Water Act. I feel this legisla-
tion should be operative only when a risk to health and the environment cannot
be suflSciently presented or reduceti by other Federal laws.

An Amendment has been offered to S. 3149. The Amendment No. 21 would
permit the granting of equitable relief where there is a risk to human health
without requiring proof by the plaintiff rather the burden of proof would be
shifted to the defendant to demonstrate that no harm to human health exists.
This seems to me to be an impossible legal and scientific burden and should be
eliminated.

Any added costs from unnecessary and impractical testing requirements will
be felt throughout the host of vital consumer related industries dependent upon
the chemical industry for their essential raw materials. Therefore, I believe that
Section 6 of S. 3149, the section which provides authority to restrict or limit
manufacturing and sales, should have language added to it to the effect that

248

when regulations and other major actions are initiated under the proi>osed act
that they are evaluated for their impact upon jobs and upon the economy.

I would welcome the opportunity to speak with you or Mr. John Steer further
on this matter at your convenience. Please do not hestitate to call me if I can be
of any help in this matter.
Yours sincerely,

Burton E. Cash,

Plant Manager.

E. I. DU Pont de Nemours & Company,

Flcyrence, S.C., January 19, 1976.

Re Toxic Substances Control Lregislation.
Hon. J. Strom Thurmond,
U.S. Senate,

Dirkscti Office BuiMing,
Washington, B.C.

Dear Strom : You will recall from your visits to our plant that we employ 650
people at this location. Our product is "MYLAR" ^ a tough plastic film used by
the following industries : magnetic tape, electrical insulation, packaging, micro-
film, engineering drawings, and laminating. Our new Plant Manager is Dr. R. D.
Pruett and lam writing you at his request.

Despite the firm commitment of the chemical industry to the prevention of
undue risk to human health and the environment from exposure to toxic chemi-
cals, we are deeply disturbed and concerned about the provisions of the toxic
substances control bills currently under consideration by the Committees of the
Congress.

We support appropriate legislation in this area, but the pending bills ( S. 3149
and H.R. 10318) are overly burdensome to industry and detrimental to the public
interest. They would impose costly and unnecessary testing requirements with
respect to new and existing chemical substances, in many cases without regard
to the relative level of risk which may be involved. They require the promulgation
of rules governing the production and use of chemical substances on the mere
possibility that these substances may present an unreasonable risk, and do not
even require the preparation of an economic impact statement although the
regulations could ban the production of a chemical, shut down the plants making
it or using it. and terminate the jobs involved. The bills would also create uncer-
tainty in the enforcement of Federal laws by encouraging duplicative action by
different Federal agencies and would permit the EPA to pick and choose among
potentially applicable laws.

These are correctible defects. In fact, legislation which met many of these
concerns passeil the House of Representatives in the last Congress. A similar
bill, H.R, 7664, has been introduced in the current Congress by Rept. John Mc-
Collister. We urge Members of Congress to actively support legislation like the
McCollister bill, H.R. 7664. and to work against the enactment of legislation which
would threaten entire industries with needless regulation without offering added
assurance of public safety.

I hope you will also voice your concern to Members of the Committee now
considering toxic substances control bills. Should you want more details on our
concerns. I will supply it.

We know that we can always depend on you to take a realistic position on such
issues.

Sincerely,

R. D. Pruett,

Plant Manager.
Per: M. B. Wallace, Jr.,
Employee Relations Superinteyident.

1 Reg. U.S. Patent Office for rhi Pon't polyester film.

249

Fiber Industries, Inc.,

January 19, 1976.
Hon. J. Strom Thurmond, ^
U.S. Senate Office Building,
Washi7ifftoti, D.C.

Dear Senator Thurmond : I am writing to you as Plant Manager of Fiber
Industries Palmetto Plant located in Darlington County concerning certain op-
position to S. 3149 (Toxic Substances Control Bill) which is now before the
Senate Commerce Committee.

I am certainly in favor of sound legislation for control of toxic substances to
the greatest extent possible through existing regulatory agencies. S. 3140 in its
present form would, however, encourage duplication and uncertainty with respect
to laws administered by the administrator.

The term "unreasonable risk" is used throughout the bill and seems to me to
be too broad which, along with the term "may present," will very probably
result in unnecessarily, costly and progress-stifling requirements for testing
and screening.

Any added costs from unnecessary testing requirements will be felt throughout
the vital consumer-related industries such as ourselves which dei^end on the
chemical industry for their raw materials. I believe, therefore, that Section 0
should have hinguage to the effect that when regulations and other major actions
are initiated they be evaluated for their impact on jobs and upon the economy
as well as health risk.

In summary, I hope that correctable general and vague language will be changed
so that unreasonable burdens are not placed where unreasonable risks do not
in fact pose substantial danger.
Yours truly,

E. J. Scott, Plant Manager.

Anderson, S.C, Mareh 15, 1916.

U.S. Senator Strom Thurmond,
Senate Office Building,
Washington, D.C.

Dear Senator Thurmond : I am greatly concerned over the phenomenal growth
of reguhitions and regulatory agencies. It api)ears that Congress and the Presi-
dent have only one approach to solving our problems as a nation and that is to
create more regulations and agencies to administer these. What we need today
is less rather than more governmental regulation of our business and individual
hves.

As a typical citizen, it is obvious to me that Congress has put little thought
into the total ramifications and consetpiences of a given regulation or set of
regulations. In most cases an exi>ensive. inefficient, bungling fedeal agency is
created. Further the citizen and business in the U.S. must bear the brunt of more
red tape. And in terms of business, many regulations will be indirectlv respon-
sible for the slow death of capitalism.

Specifically I am opix)sed to the propo.sed toxic substances legislation presently
before Congress. There are already in excess of 25 healtli and environmental laws
presently in effect. These laws give the federal government adequate authority
to contol dangerous substances.

The Environmental Protection Agency would be given near absolute control of
the cheniical industry. In effect making the administrator of this group a dicta-
tor over the chemical industry.

This legislation would have an inflationary impact through increased cost of
goods to the consumer. It would also reduce the discovery of new chemical pro-
ducts. And finally, it would reduce the number of jobs available.

As one of you constituents. I would appeciate knowing vou position on this
proposed legislation and if you believe it will became law. Thank you for your
kind indulgence.

Respectfully,

Dr. Herbert L. Whitaker, .Jr.

79-313 O - 77 - 17

250

Whitestone Chemical, a Department of BASF Wyandotte Corp.,

Spartanburg, S.C., January 19, 1976.

Hon. Strom Thurmond,
U.S. Senator, Aiken, S.C.

Dear Senator Thurmond : Whitestone Chemical, a Department of BASF-
Wyandotte Corporation, is a manufacturer of specialty chemicals for the textile,
paper, leather and other industries here in Spartanburg. Current employment is
forty-one with an annual payroll of approximately $500,000. Whitestone is a sig-
nificant contributor to the economic well-being of the Spartanburg area.

My company is firmly committed to the prevention of undue risk to human
health and the environment from exposure to toxic chemicals. We are, however,
deeply disturbed and concerned about the provisions of certain toxic substances
control legislation, S. 3149 and H.R. 10318, currently under consideration by the
Senate Commerce Committee and the House Interstate and Foreign Commerce
Committee.

Review of the controls now in existence on toxic substances does convince us
that some additional legislation is appropriate. However, S. 3149 and H.R. 10318
represent, in our opinion, legislative overkill. We believe they go far beyond what
is required to provide reasonable protection to chemical workers, consumers and
the general public and would burden all of these groups with costly and unneces-
sary testing equirements with respect to existing and new chemical substances.
These bills lack standards for exercising good judgment as to the relative level
of risk that may be involved ; rather, they would condemn all chemicals without
regard to historic data, the relative level of risk that may be involved or the
economic impact that would result. Appropriate legislation must provide for
taking the economic impact into account because the cost of complying with the
legislation will fall on consumers and the general public and our country in total.

As stated previously, we do believe, that some further legislation is required
and H.P. 7664 introduced into the current Congress by Representative John
McCollister would accomplish what we believe is needed. H.R. 7664 would provide
necessary protection at reasonable cost. We urge you to support actively the
McCollister bill and to oppose S. 3149 and H.R 10318.

Even though Whitestone is a department of BASF- Wyandotte Corporation, we
operate as a separate company and therefore must pay our own way. The eco-
nomic impact associated with the toxic substances control bills could be ex-
tremely detrimental to the continued operation of Whitestone, and many other
small chemical companies in South Carolina.

If you share our concerns, we hope that you will voice them to the members of
the Senate Committee now considering toxic substances control bills. We would
appreciate learning your position on this legislation.
Sincerely.

T. W. Beal, Plant Manager.

E. I. DU Pont de Nemot'rs & Co..
Florence, S.C, January 10, 1976.

Re Toxic Substances Control Legislation.
Hon. J. Strom Thurmond,
U.S. Senate, Dirkscn Office Building,
Washington, B.C.

Dear Strom : You will recall from your visits to our plant that we employ 650
people at this location. Our product is "MYLAR"*, a tough plastic film used by the
following industries : magnetic tape, electrical insulation, packaging, microfilm,
engineering drawings, and laminating. Our new Plant Manager is Dr. R. D.
Pruett and I am writing you at his request.

We support appropriate legislation in this area, but the i)ending bills ( S. 3149
and H.R. 10318) are overly burdensome to industry and detrimental to the public
interest. They could impose costly and unnecessary testing requirements with re-
spect to new and existing chemical substances, in many cases without regard to
the relative level of risk which may be involved. They require the promulgation

251

of rules governing the production and use of chemical substances on the mere pos-
sibility that these substances may present an unreasonable risk, and do not even
require the preparation of an economic impact statement although the regula-
tions could ban the production of a chemical, shut down the plants making it or
using it, and terminate the jobs involved. The bill would also create uncertainty
in the enforcement of Federal laws by encouraging duplicative action by differ-
ent Federal agencies and would permit the EPA to pick and choose among poten-
tially applicable laws.

These are correctible defects. In fact, legislation which met many of these con-
cerns passed the House of Representatives in the last Congress, A similar bill,
H.R. 7664, has been introduced in the current Congress by Rep. John McCollister.
We urge Members of Congress to actively support legislation like the McCollister
bill, H.R. 7664, and to work against the enactment of legislation which would
threaten entire industries with needless regulation without offering added assur-
ance of public safety.

I hope you will also voice your concern to Members of the Committee now con-
sidering toxic substances control bills. Should you want more details on our con-
cerns, I will supply it.

We know that we can always depend on you to take a realistic position on such
issues.

Sincerely,

R. D. Pruett.

Plant Manager.
Per: M. B. Wallace, Jr.,
2'Jmployee Relations Superintendent.

Ashland Chemical Co.,
DiviMon of Ashland Oil, Inc.,
Charlotte, N.C., February 2, 1976.

Hon. Strom Thurmond,
U.S. Senate,

Dirkscn Senate Office Building, Washington, D.C.

Dear Senator Thurmond : As regional manager of the Industrial Chemicals
»& Solvents Division of Ashland Chemical Company stationed in Charlotte, N.C., I
am very much concerned about the so-called Toxic Substance Control measures,
which are currently under consideration by the Committees of the Congress. In-
cluded under my jurisdiction are the two Carolinas; and the havoc that would
be raised, not only in this area but industry-wide if the bills in question should
be enacted into law, would be monumental. Once again, therefore, I am seeking
your assistance.

Despite the firm commitment of the chemical industry to the prevention of
undue risk to human health and the environment from exposure to toxic chemi-
cals— and we support legislation in this area — the provisions of the pending
measures, Senate bill 3149, introduced by Senator John Tunney. and House Bill
10318, introduced by Representative Bob Eckhardt, are objectionable as being
both overly burdensome to industry and detrimental to the public interest.

These bills could impose costly and unnecessary testing requirements with
respect to the new and existing chemical substances, in many cases without re-
gard to the relative level of risk which may be involved. They require the pro-
mulgation of rules governing the production and use of chem.ical substances on
the mere possibility that these substances may present an unreasonable risk,
and do not even require the preparation of an economic impact statement al-
though the regulations could ban the production of a chemical, shut down the
plants making it or using it, and terminate the jobs involved. The bills also
would create uncertainty in the enforcement of Federal laws by encouraging
duplicative action by different Federal agencies and would permit the EPA to pick
and choose among potentially applicable laws.

These are correctible defects. In fact, legislation which met many of these
concerns passed the House of Representatives in the last Congress. A similar bill,
H.R. 7664, has been introduced in the current Congress by Rep. John McCollister.
We urge Members of Congress to support, actively legislation like the McCollister
bill, H.R. 7664, and to work against the enactment of legislation which would
threaten entire industries with needless regulation without offering added assur-
ance of public safety.

252

I hope that you also will voice your concern to Members of the Committee now
considering toxic substances control bills.

I am enclosing a summary of industry's concerns over the aforementioned bills
which provides more detailed information w ith respect to such concerns. In addi-
tion, I shall be most happy to discuss them with you at any time you are in this
area.

Thank you for your assistance.
Sincerely yours,

A. T. MOEPHY.

Summary of Some of the Major Concerns With Toxic Substances Control

Legislation

(H.R. 10318 (Eckhardt)— S. 3149 (Tunney))

1. Testing. [Sec 4] The Administrator of EPA should be permitted to require
testing of chemical substances where necessary to protect against an unreason-
able risk to health or the environment. However, both H.R. 10318 and S. 3149
require the Administrator to order testing if a chemical substance "may present"
an unreasonable risk, and they thus threaten unnecessary testing which is both
costly and time-consuming. Both bills contain undesirable provisions for es-
tablishment of extensive public priority lists of suspect chemicals, without ap-
propriate procedural safeguards, which arbitrarily restrict the EPA Admin-
istrator's authority and could unfairly damage or destroy a product's trade
acceptance and reputation before recommended testing could be completed.

2. Premarket Screening. [Sec. 5] Premarket screening, which for all practical
purposes results in an EPA premarket approval, should be limited to those chemi-
cals that are likely to pose a substantial danger — an unreasonable risk of death
or severe or widespread harm. S. 3149 requires premarket screening — and threat-
ens indefinite delay of new product development and marketing — with respect
to all new chemical substances and significant new uses of established sub-
stances, regardless of the risks involved. Under H.R. 10318 screening jjiay be re-
quired on the mere possibility of an unreasonable risk.

3. Regulation. [Sec. 6] A sound, balanced approach to controlling toxic sub-
stances should require that regulatory actions be aimed at the distribution and
use of those substances only when necessary to prevent an unreasonable risk
to health or the environment. Both pending bills require the promulgation of
such rules on the mere possibility that a chemical substance presents or con-
tributes to an unreasonable risk. Under certain circumstances they can be put
into effect immediately. They do not require the Administrator to use the least
burdensome regulation required to prevent the risk. They do not require the
Administrator to include an economic impact statement in any such rule, even
if the rule bans the production of a substance, shuts down the plant making and
using it, and ends the jobs involved in manufacture and use.

4. Unreasonable RisJx. [Sec. 6] S. 3149 attempts a legislative definition of
"unreasonable risk to human health and the environment." The definition pro-
posed by S. 3149 is both vague and unworkable. H.R. 10318 also unwisely and
unnecessarily broadens the concept of unreasonable risk by making the concept
applicable even if the substances make a minute contribution to any risk, even
a naturally occurring one.

5. Imminent Hazard. [Sec. 7] Of serious concern is that the total impact of
Sections 4, 5, 6, and 7 of H.R. 10318 and S. 3149 is in the direction of a zero risk
concept, that is, protection of society from all possible health hazards. Yet all
social progress is predicated on some level of risk assumption. Our good quality
and style of life today would never have been achieved by a no-risk approach
to progress. What is essential is that we avoid unreasonable risks and we sup-
port legislation to this effect — not legislation reflecting a zero risk, no-hazard
approach.

6. Reporting. [Sec. 8] Toxic substances control legislation should empower the
regulatory agency to obtain information from manufacturers as necessary to
facilitate its administration of the law, but avoid overburdensome paperwork
requirements. S. 3149 unreasonably requires both the immediate transmittal to
EPA and the retention of all health and safety data, Including any letters from
anyone concerning an alleged adverse effect of a chemical substance and any re-
port of illness allegedly related to chemical exposure. H.R. 10318 imposes crimi-

253

nal penalties for violation of the impossibly vague requirement that a manufac-
turer immediately inform the Administrator about any information which
"reasonably supports" the conclusion that a chemical substance presents an
unreasonable risk. In addition, both bills require manufacturers to prepare a list
of all chemical studies conducted by or for them, regardless of their need, sig-
nificance, or validity.

7. Citizen Petitions. [Sec. 21] H.R. 10318 and S. 3149 give any person the right
to petition the Administrator to commence a proceeding for the issuance of a
rule under various sections of the legislation, and, more remarkably, give any
such person the right to a de novo trial in Federal district court if the Admin-
istrator does not accede to the request. This means that every Federal court
could be turned into a mini-EPA, forced to hear complex, scientific testimony
presented by any person with whom EPA disagreed. This is not judicial review
of agency action ; there is no weight given to the Administrator's discretion or
exi)ertise. Moreover, the very existence of this type review threat further erodes
the likelihood that the Administrator will be in a position to make reasonable
and prudent judgments in discretionary areas — judgments which are essential
in administering any of the proposed bills because of the severe economic and so-
cial consequences that could result from any significant action.

8. Overlapping Lairs. [Sec. 9] Sound legislation should provide for the control
of toxic substances, to the greatest extent possible, through existing regulatory
authorities. H.R. 10318 and S. 31-J9 would create uncertainty in the enforcement
of Federal laws by encouraging duplicative action by Federal agencies and, with
respect to laws administered by the Administrator, would permit the Admin-
istrator to ''pick and choose" among potentially applicable laws.

9. Scope and Coverage. [Sec. 3J lioth S. 3149 and H.R. 10318 are, at least
potentially, applicable to every chemical substance and every mixture of chemical
substances. Since every substance, product or commodity is covered by
the bill's definitions of chemical substance and mixture, great care must be
taken in drafting the legislation to prevent its unfair and unnece.ssary appli-
cation to chemicals that do not present significant risks. Neither bill reflects
this care. It is unnecessary for the legislation to cover mixtures of chemical
substances, research and test chemicals, reagents, or catalysts, unless they pose
an unreasonable risk.

10. Confidential Industry Data. [Sec. 14] To prevent unfair competitive damage,
the legislation must provide careful protection against public disclosure for con-
fidential company data with respect to production, chemical composition, mar-
keting plans and other business secrets,

11. All of the above concerns are correctal)le defects. In fact, legislation which
met many of the.se concerns passed the Hou.se of Representatives in the last
Congress. A similar bill, H.R. 7664, has been introduced in the current Congress
by Rep. John McCollister. We urge Members of Congre.«?s to actively suppf)rt
legislation like the McCollister bill, H.R. 7664, and to work against the enact-
ment of legislation which would threaten entire industries with needless regu-
lation without offering added assurance of public safety.

Mr. TiiURMOXD. I wish to say too that I think the administration's
position on this bill is a sound position. Tliis is the administration's
position :

While the Administration has taken the lead since 1971 in urging legislation
to control toxic substance.^, it strongly oppo.ses enactment of this bill.

S. 3149 unnecessarily overburdens both the regulatory agency and the regu-
lated industry by :

Requiring premarket notification on all new substances regardless of whether
or not they are even potentially toxic.

Requiring the regulatory agency to make detailed findings even on those sub-
stances s\iiich it feels need no regulation or further testing.

The bill does not adequately protect against the unauthorized relea.se of trade
.secrets and proprietary information. Such protection is critical to the effective
work of the toxic controlled program. Also provides for citizen petition, citizen
civil action against nondiscretionary acts, and compensation for attorney's fees.

These provisions unnecessarily invite further litigation without any major
benefit over the normal judicial review procedures in the legislation.

Mr. President. I think the administration is on sound ground here.
As it says, the administration has taken the lead since 1971 in urging

254

legislation to control toxic substances, but it cannot support this bill,
and, in fact, strongly opposes the enactment of the bill for the reasons
I have just stated.

For those reasons, Mr. President, and others I shall not take time
now to mention, I shall vote against this measure. All of us have a sin-
cere desire to protect the public from toxic chemical substances, but
this legislation goes much further than prudence and the public inter-
est require.

Mr. TuxNEY. Mr. President, I make it clear that the legislation that
I hope we pass in a few minutes is designed to assure that chemicals
that are used in high volume are going to be tested for safety.

As a matter of fact, even low volume chemicals will be tested if there
is concern as to their effect on the environment or on human health.

Section 4 states that if a chemical substance or mixture may present
a significant human or environmental exposure because of production
in substantial quantities or for other reasons, and the substance or mix-
ture may perhaps present an adverse effect on health and the environ-
ment, the Administrator must require testing if there are insufficient
data or experience to reasonably determine or predict the effects and
testing is necessary to develop the data.

So there should be no question in anyone's mind that, where we have
substantial amounts of a chemcial being produced and being disbursed
throughout the environment, the Administrator is required to order
testing where he does not have adequate data to be able to make up his
mind on the evidence and where the testing is needed to develop the
data.

I think it is very clear.

Mr. Hartke. Mr. President, I quite agree with the Senator from Cal-
ifornia. There is no question that one of the problems we have in Amer-
ican society today is that we are increasingly using a volume of
chemicals which is absolutely going to astonish most individuals and as
far as the people are concerned provide for them an exposure which
might not otherwise be dangerous but simply by the sheer volume of
the chemical exposure present a hazard to the health or to the environ-
ment of this Xation.

The Administrator is required to go ahead and deal with this type
of situation. In other words, he will, in fact, address himself to this
potential hazard and will make the necessary testing, necessary reports,
and necessary findings.

I point out that generally speaking we will have in here, as I under-
stand it only one reference to specific items. Generally speaking, I think
it is better legislative procedure to keep legislation general and not deal
with specific items. For that reason, I think we are justified in not put-
ting an amendment in this bill which really specifically deals with high
volume chemicals. On the other hand, I think that if it is omission as a
specific amendment could be interpreted as an indication by Congress
that we did not intend to cover such items, then I would feel compelled
to make sure that Ave had an amendment of that nature in the bill. But
as has been indicated by the Senator from California, under section 4,
the testing of chemical substances and mixtures, it is fully anticipated
that the Environmental Protection Administrator will require that
testing and will act accordingly.

255

Mr. TuNXEY. Mr. President, a question has been raised concerning
the possibility that a State law, a State effluent standard, for example,
established pursuant to the Federal AVater Pollution Act would be pre-
empted if there were in existence a toxic substance rule pertaining to
the manufacture, distribution, or disposal of a chemical substance that
was subject to the effluent standard. That emphatically is not the case.
The State is only preempted under the bill from establishing a stand-
ard relating to the manufacture, distribution, or disposal inconsistent
with the standards authorized under section 6. State effluent or air pol-
lution standards pursuant to Federal law would not be preempted by
section 13.

Mr. Pearson. Mr. President, I ask unanimous consent to have
printed in the Record a statement by the distinguished Senator from
Connecticut (Mr. Weicker).

The Presiding Officer. Without objection, it is ordered.

Statement of Senator Weicker

I believe the Toxic Substance Contol Act is the most important piece of envi-
ronmental le^slation to come before the Congress this year. It places the respon-
sibility of proving the safety of new chemicals right where it belongs — on the
government. With 500 to 1.000 new chemical substances being introduced into
commercial use every year, the government must have the power to act. The
illness and death attributed to kepone, vinyl chloride, asbestos, and other chem-
icals is tragic evidence that that power does not now exist,

I have long supported and I am a cosponsor of this measure which places as
one of our greatest environmental priorities the protection of the public against
the health hazards associated with dangerous chemicals,

LEGISLATTVE HISTORY TO ACCOMPANY MODEL ATTORNEYS^ FEES PROVISION

Mr. TuNNEV. Mr. President, attorneys' fees provisions appear in a
number of places throughout this legislation [e.g., Sec. 19(c)(3)].
These provisions allow a court to award costs of suit and reasonable
fees where ''appropriate." These provisions are very important to the
proper vindication of rights under this legislation. I would like to offer
some explanation which in my opinion will clarify the operation o.f
those provisions.

Until recently, the courts often provided for effective actions by pri-
vate citizens through the award of costs and fees, even in the absence
of specific statutory authorization, under the ''private attorney gen-
eral" rationale. However, in a recent decision. Alyeska Pipeline Serv-
ice Co. against Wilderess Society, the Supreme Court held that —

Courts lacked discretionary power to award attorneys' fees to petitioners who
sought to vindicate "imi)ortant statutory rights for all citizens" , . . unless there
was specific statutory authorization for such awards , . . The circumstances under
which attorneys' fees are to be awarded and the range of discretion in the court
for making those awards are matters for Congess to detemine.

In light of that decision, the fees and costs provisions of this legisla-
tion follow the precedent of over 50 Federal statutes in permitting fee
shifting by the courts.

This provision Avould allow an award of fees and costs to any party
when "appropriate," a word which should liberally construed to effec-
tuate the purposes of this act. Thus, in typical circumstances, the court
should follow prevailing case law which holds that a successful plain-

256

tiff "should ordinarily recover an attorneys' .fee unless special circum-
stances would render such an award unjust." Newman v. Piggie Park
Enterjnnses, Inc., 390 U.S. 400, 402 (1968) (per curiam). "Plaintiff"
in this sense is used to mean the parties seeking to enforce the rights
granted by this section and can include an intervenor, or a defendant
in some cases. See e.g., Shelley v. Kramer, 334 U.S. 1 (1948).

In exceptional circumstances, fees and costs might also be awarded
to defendants where they must "defend against unreasonable, friv-
olous, meritless or vexations actions * * *" United States Steel Corp. v.
United States, 385 F. Supp. 346, 348 (W.D. Pa. 1974). Where plain-
tiff's proceeding is brought in good faith or on the advice of component
counsel, fees and costs would ordinarily be denied to a prevailing
defendant. Richardson v. Hotel Corporation of America. 332 F. Supp.
519 (E.D. La. 19711), aff'd 468 F. 2d 951 (5th Cir. 1972). The stand-
ard for awarding fees and costs to a prevailing defendant is not the
same as for a plaintiff because, if it were, the risk, to the average citizen
of bringing suit under this section would be so great it would discour-
age such suits.

Fees and costs would be awarded to a "successiful plaintiff" under
this provision where there was a final court order granting the relief
requested by plaintiffs, or as a matter of interim relief pending the
outcome of the case. The provision does not require the entry of a final
order before fees or costs mav be recovered. See Bradley v. School
Board of the City of Richmond, 416 U.S. 606 (1974) ; Mills v. Electric
Auto-Lite Co., 396 U.S. 375 (1970). Such awards are especially im-
portant where a party has prevailed on an important matter in the
course of the litigation even where he does not ultimately prevail on
all the issues. See Bradley, supra, and Mills, supra. For purposes of
the award of fees and costs, it is "appropriate" to make awards where
the parties have vindicated rights through a consent judgment, or
without formally obtaining relief, or where such award is in the public
interest without regard to the outcome of the litigation. Kopet v.
Esquire Realty Co., 523 F. 2d 1005 (2d Cir. 1975) ; ParJiam, v. South-
western Bell Telephone Co.. 433 F. 2d 421 (8th Cir. 1970) ; Richards v.
Griffith Rubier Mills. 300 F. Supp. 338 (D. Ore. 1969) ; Thomas v.
Honeyhrook Mints, Inc., 428 F. 2d 981 (3d Cir. 1970).

By specifying a general rule for the amount of fees to be awarded,
this provision requires the method of calculating fees be no different
than that now being utilized in other fields of law as, for example,
antitrust and securities regulation litigation. The "actual time" spent
is that reasonably calculated to advance the client's interest. The Stan-
ford Daily v. Zurcher, 64 F.R.I). 680 (N.D. Cal. 1974) , and the amount
can be adjusted for factors including, inter alia, the contingent nature
of the success or the quality of the work performed. Lrndy Bros.
Builders v. American Radiator (€• Standard Sanitary Corp.. 487 F. 2d
161 (e3d Cir. 1973), on remand, 382 F. Supp. 999 (E.D. Pa. 1974), or
benefits to the public from the suit. Davis v. County of Los Angeles,
8 E.P.D. 9444 (CD. Cal. 1974). Fees should not be reduced merely
because the attorneys are salaried employees of public interest and/or
foundation -funded law firms.

Fees and costs awarded under this provision may be assessed against
the United States, including any of its agencies and officers acting in
an official capacity, the same as against a private party.

257

Finally, since expert witnesses are o.f ten needed to make an adequate
presentation to a court, such fees are also provided for in this statute.
They would be in addition to those now provided in 28 U.S.C. 1920
and 28 U.S.C. 1821.

The policy outlined above should apply to the procedures under
section 23 to the extent applicable.

Mr. Xelsox. Mr. President, I would like to take this opportunity
to elaborate and clarify an important point contained in the com-
mittee's report. On page 26, in reference to amendment Xo. 21 [Sec.
17(a)] sponsored by the Senator from Michigan (Mr. Gary Hart),
the Senator from Illinois (Mr. Percey), and myself, regarding the
burden of proof a plaintiff must sustain in order to gain relief under
the laws administered by the Environmental Protection Agency, the
report states :

The amendment attempted to rectify a three judge panel decision of the
Eighth Circuit concerning relief set against the Reserve Mining Company. As
decisions reached by the Courts in subsequent appeals is consistent with the
requirements of Amendment No. 21 the amendment is unnecessary.

I believe it has for many years been the law that courts have full
authority to protect human life and health when either is seriously
threatened. However, some courts have expressed doubts about what
the law is, and how it should be interpreted. I believe that any court of
law or anv governmental administrator when faced with a real risk of
serious injury to human beings would have to make sure that the
danger is removed.

Amendment Xo. 21 is aimed at those situations where some evidence
of a serious potential hazard exists but the evidence is inconclusive.
Amendment Xo. 21 would prohibit a court from denying equitable
relief under any kct administered by the EPA where a risk to public
health is alleged and established.

Amendment X'o. 21 attempts to clarify existinjr law. This legislation
does not cliange the law. If enacted, this legislation would only clarify
and reinforce existing tenets of congi-essional policy and existing law,
tliat precautionary action shall be taken to prevent ])erceivcd harm
where evidence of a serious potential hazard exists but the conclusive
scientific evidence is not yet available.

On the merits of the issue, I agree with the committee that the law
is clear and that the Eighth Circuit Court of Appeals sitting en banc,
in reviewing the Resen^e Mining Co. decision, has indeed rectified
many of the mistakes contained in the ori2:inal eighth circuit decision.
However, susequent court decisions reveal that the courts are still not
clear as to Congress' intent as well as what the law requires in
these most serious environmental health cases.

On March 19. 1076, the F.S. Court of Appeals for the District of
Columbia sitting en banc affirmed an Environmental Protection
Afifency reinilation regarding the reduction of lead levels in gasoline.
The 5 to 4 decision deals specifically with the question addressed by
amendment Xo. 21.

The Administrator determined that leaded gasoline automotive
emissions present "a sis:nificant risk of harm" to the public
health * * *. Based on this finding, the Administrator issued the
re;2:ulations requiring annual reductions in the lead content of leaded
gasoline.

258

The Court held that—

In applying the "will endanger" standard the Administrator is authorized to
assess risks of harm and, where the risk is found significant, to act to prevent
the harm from happening. Thus the regulatory action under this precautionary
statute should precede, and hopefully prevent, the perceived harm.

The petitioners in this case argued that the "will endanger" stand-
ard requires a high quantum of actual proof, proof of actual harm
rather than a "significant risk of harm." The Court stated :

It is our view that the Administrator's interpretation of the standard is the
correct one.

The court held —

The meaning of "endanger" is not disputed. Case law and dictionary definition
agree that endanger means something less than actual harm. When one is
endangered, harm is threatened ; no actual injury need ever occur ... a statute
allowing for regulation of the force in danger is, necessarily, a precautionary
statute. Regulatory action may be taken before the threatened harm occurs;
indeed, the very existence of such precautionary legislation would seem to
demand that regulatory action precede, and, optimally, prevent, the perceived
threat.

The Court specifically refers to the en banc decision of Reserve,
Mining/ Company v. EPA, 514 F. 2d 492 (8th Cir. 1975) (en banc),
in inte^rpreting the meaning of "endanger." The eighth circuit's unani-
mous conclusion fully supports the District of Columbia Appeals
Court standard of "will endanger." The eighth circuit held:

In the context of this environmental legislation, we believe that Congress used
the term "endangering" in a precautionary or preventive sense, and, therefore,
evidence of potential harm as well as actual harm comes within the preview of
that term,

( See Reserve Mining Campcmy vs. EPA, supra, 514 F. 2d at 528)

The District of Columbia Appeals Circuit Court held :

. . . based on the meaning of the statute . . . and the Reserve Mining prece-
dent, we conclude that the "will endanger" standard is precautionary in nature
and does not require proof of actual harm before regulation is appropriate.

In the Reserve Mining case, the eighth circuit allowed regulation of
the daily discharge of 67,000 tons of taconite tailings into Lake
Superior on only a "reasonale" or "potential" showing of danger,
hardly the probable finding urged by the petitioners in the EPA lead
case as a proper reading of the "endanger" language. The appeals
court states:

Reserve IMining convincingly demonstrates that the magnitude of risks suffi-
cient to justify regulation is inversely proportional to the harm to be avoided.

eTudije Wright, in commenting for the majority of the D.C. circuit
regarding lead levels in gasoline, correctly has viewed the congres-
sional policy and has correctly interpreted the law in determining
what standard of evidence is renuired before appropriate relief can
be fifranted. However, Judge Wilkey, who joined with Judge Tamm
and Robb in dissent, raised questions regarding what standard of
proof is required before relief is granted. His dissent states, in part :

For the Court's opinion to hold that the Administrator can dispense with proof
of actual harm, i.e.. what has occurred in the past, and can nevertheless vsomehow
determine potential harm, is to grant the plaintiffs license for the widest specula-
tion we have always under scientific conclusions, above all demand that proof by
events recorded and observed.

259

Apparently, the law is not sufficiently clear if our judges on the Dis-
trict of Columbia Circuit Court of Appeals specifically disagreed with
what burden of proof must be sustained by a plaintiff before appro-
priate relief may be granted. HowcAxr clear the Eighth Circuit Court
of Appeals and the majority of the District Court of Appeals and
j Members of Congress believe the law is, as currently drafted, clarifica-
I tion would be helpful. Amendment No. 21 is not as unnecessary as the
committee report would indicate. There is question in the judiciary as
to what the law is. I believe the law is clear, and I hope this legislative
history will help the courts in understanding Congress intent to pro-
tect the public's health before significant harm can occur. At the very
least, the dissent by Judge Wright and others reemphasize the merit
in enacting legislation to make Congress intent unmistakably clear.

Mr. President, I ask unanimous consent that a Library of Congress
American Law Division opinion on this issue be printed in the Record.

There being no objection, the material was ordered to be printed in
the Record, as follows :

Congressional Research Service,

Washington, D.C., March 25, 1976.
To : Hon. Gaylord Nelson, Attention : Jeff Nedelman.
From : American Law Division,
I Subject : Reserve Mining and Ethyl Corporation Interpretation of Findings Nec-
I essary to Show That a Pollutant is "Endangering" the Public Health.

This responds to your request for an analysis of the above-noted subject as in-
terpreted by the decision of the United States Court of Appeals for the Eighth
Circuit in Reserve Mining Co. v. United States, 417 F.2d 492 (8th Cir. 1975)
{en banc), and by the decision of the United States Court of Appeals for the
District of Columbia in Ethyl Corp. v. Environmental Protection Agency, No.
78-2205, March 19, 1970 (en banc). The 5-judge panel of the Eighth Circuit was
unanimous in its decision ; the 9-judge panel of the District of Columbia Circuit
was split 5 to 4.

Both the 8th Circuit and the majority of the D.C. Circuit agreed that the con-
cept of endangerment includes a precautionary or preventive element, so that
proof of potential harm can establish endangerment, and it is not necessary to
establish that actual harm has already occurred. In this context the language at
issue in Reserve Mining was former section 1160(g) (1) of Title 33, U.S.C. Code,
predicating an abatement action on a finding that "pollution of water ... is en-
dangering the health or welfare . . ." At issue in Ethyl Corp. was section 211
of the Clean Air Act, 42 U.S.C. § 1857f-6c, permitting the Administrator of EPA
to regulate a fuel additive "if any emission products of such fuel or fuel additive
will endanger the public health or welfare."

The following analysis appears in the 8lh Circuit's opinion in Reserve Mining,
514 F.2d at 528-529;

[20] An action under the FWPCA requires proof of an additional element.
The United States must establish that the water pollution which is violative of
state water quality standards is also "endangering the health or welfare of per-
sons." § 1160(g) (1).

In this review, we must determine whether "endangering" within the meaning
of the FWPCA encompasses the potential of harm to public health in the degree
shown here.

[21, 22] Provisions of the FWPCA are aimed at the prevention as well as the
cure of water pollution. The initial sentence of the FWPCA reads :

The purpose of this chapter is to enhance the quality and value of our water
resources and to establish a national policy for the prevention, control, and abate-
ment of water pollution. [33 U.S.C. § 1151(a).]

The term "endangering," as used by Congress in § 1160(g) (1), connotes a lesser
risk of harm than the phrase "imminent and substantial endangerment to the
health of persons" as used by Congress in the 1972 amendments to the FWPCA,
33 U.S.C. § 1364 (Supp. 1974).

260

[23] In the context of this environmental legislation, we believe that Congress
used the term "endangering" in a precautionary or preventive sense, and there-
fore, evidences of potential harm as well as actual harm comes within the pur-
view of that term. We are fortified in this view by the flexible provisions for in-
junctive relief which permit a court "to enter such judgment and orders enforc-
ing such judgment as the public interest and the equities of the case may require."
33 U.S.C. § 1160(c) (5).

We deem pertinent the interpretation given to the term "endanger" by Judge
Wright of the District of Columbia Circuit in his analysis of the congressional
use of the word "endanger" in the context of a provision of the Clean Air Act.
42 U.S.C. § 1857f-6c(c) (1) (A) (1970).

Judge Wright observed :

The meaning of "endanger" is, I hoi)e, beyond dispute. Case law and dictionary
definition agree that endanger means something less than actual harm. When one
is endangered, harm is threatened; no actual injury need ever occur.

*******
"Endanger," * * * is not a standard prone to factual proof alone. Danger is a
risk, and so can only be decided by assessment of risks.

***** * *

[A] risk may be assessed from suspected, but not completely substantiated,
relationships between facts, from trends among facts, from theoretical projec-
tions from imperfect data, or from probative preliminary data not yet certifiable

as "fact." [Ethyl Corporation v. Environmental Protection Agency, F. 2d

, (D.C. Cir., Jan. 28, 1975) (dissenting op. at , ) (emphasis in

original) (footnote omitted).]

Although the Supreme Court has not interpreted the concept of "endangering"
in the context of an environmental lawsuit, it has emphasized the importance
of giving environmental legislation a "common-sense" interpretation. Mr. Justice
Douglas, writing for the Court, said :

"This case comes to us at a time in the Nation's history when there is greater
concern than ever over pollution — one of the main threats to our free-flowing
rivers and to our lakes as well * * * [W]hatever may be said of the rule of
strict construction, it cannot provide a substitute for common sense,, ^precedent,
and legislative history." [United States v. Standard Oil Co., 384 U.S. 224, 225, 86
S.Ct. 1427, 1428, 16 L.Ed.2d 492 ( 1966) .]

See United States v. RepubUc Steel Corp., 362 U.S. 482, 491, 80 S.Ct. 884, 4 L.Ed.
2d 903 (1960).

[24, 25] The record shows that Reserve is discharging a substance into Lake
Superior waters which under an acceptable but "unproved medical theory may be
considered as carcinogenic. As previously discussed, this discharge gives rise to
a reasonable medical concern over the public health. We sustain the district
court's determination that Reserve's discharge into Lake Superior constitutes
pollution of waters "endangering the health or welfare of persons" within the
terms of §§ 1160(c) (5) and (g) (1) of the Federal Water Pollution Control Act
and is subject to abatement.

The Ethyl Corp. decision cited in Reserve Mining, supra, was vacated. Judge
Wright, whose dissent in the vacated decision is quoted above in Reserve Mininf/,
wrote the majority opinion in the March 19, 1976 en bane decision in Ethyl Corp.
Judge Wright reiterated his previous analysis, and provided the following sum-
mary (slip opinion, pp. 53-56) ;

These cases, recognizing as they do the developing nature of environmental
medicine, fortify our analysis of the "will endanger" language of Section 211.
Where a statute is precautionary in nature, the evidence difficult to come by,
uncertain, or conflicting because it is on the frontiers of scientific knowledge, the
regulations designed to protect the public health, and the decision that of an ex-
I>ert administrator, we will not demand rigorous stei>by-stej) proof of cause and
effect. Such proof may be impossible to obtain if the precautionary purpose of
the statute is to be served. Of course, we are not suggesting that the Administra-
tor has the power to act on hunches or wild guesses. Amoeo makes it quite clear
that his conclusions must be rationally justified. Amoco Oil Co. v. EPA . supra, 163
U.S. App. D.C. at 180-181, 501 F.2d at 740-741. However, we do hold that in such
cases the Administrator may assess risks. He must take account of available facts.

261

of course, but his inquiry does not end there. The Administrator may apply his
expertise to draw conclusions from suspected but not completely substantiated,
relationships between facts, from trends among facts, from theoretical projec-
tions from imperfect data, from probative preliminary data not yet certifiable as
"fact," and the like. We believe that a conclusion so drawn — a risk assessment —
may, if rational, form the basis for health-related regulations under the "will
endanger" language of Section 211."*

All of this is not to say that Congress left the Administrator free to set policy
of his own terms. To the contrary, the policy guidelines are largely set, both in
the statutory term "will endanger" and in the relationship of that term to other
sections of the Clean Air Act. These prescriptions direct the administrator's
actions. Operating within the prescribed guidelines, he must consider all the in-
formation available to him. Some of the information will be factual, but much
of it will be more speculative — scientific estimates and "guestimates" of prob-
able harm, hypotheses based on still-developing data, etc. Ultimately he must
act, in part on "factual issues," but largely "on choices of policy, on an assess-
ment of risks, [and] on predictions dealing with matters on the frontiers of
scientific knowledge * * *." Amoco Oil Co. v. EPA, supra, 163 U.S. App. D.C. at
181, 501 F.2d at 741. A standard of danger — fear of uncertain or unknown harm —
contemplates no more.

That other interpretations of the "will endanger" or "endangering" standard
are possible is apparent from a reading of Judge Wilkey's dissent in Ethyl
Corp., joined by Judges Tamm and Robb. Judge Wilkey rejected the distinction
"between actual and potential between past and future harm." and continued :

The Administrator is dealing with a coniinuing situation. If there can be found
potential harm from lead in exhaust emissions, the best (and only convincing)
proof of such potential harm is what has occurred in the past (either in 50 years
of practical usage or in laboratory experimentation), from which the Adminis-
trator can logically deduce that the same factors will produce the same harm in
the future. For the court's opinion to hold that the Administrator can dispense
with proof of actual harm, i.e., what has occurred in the past, and can neverthe-
less somehow determine potential harm, is to grant the plainest license for the

^ It bears emphasis that what is herein describe as "assesment of risk" is neither
unprecedented nor unique to this area of law. To the contrary, assessment of risk is a
normal part of judicial and administrative fact-finding. Thus KPA is not attempting to
expand its powers ; rather, petitioners seek to constrict, the usual flexibility of the fact-
finding process. Petitioners argue that the Administrator must decide that lead emis-
sions "will endanger" the public health solely on "facts," or, in the words of the division
majority, by a "chain of scientific facts or reasoning leading (the Administrator) inelucta-
bly to this conclusion * * *." Division op. at 59. Petitioners demand sole reliance on
scientific facts on evidence that reputable sceintific techniques certify as certain. Typically.
.1 scientist will not so certify evidence unless the probability of error, by standard
statistical measurement, is less than 5 percent. That is, scientific fact is at least 95 percent
certain.

Sucli certainty has never characterized the judicial or the administrative process. It
mav be that the "beyond a reasonable doubt" standard of criminal law demands 95 percent
certainty. Cf. McGill v. United States, 121 IT.S. App.D.C. 179. 185 n.6, .348 F.2d 791.
797 n.f) (1965) But the standard of ordinary civil litigation, a preponderance of the
evidence,, demands only 51 percent certainty. A jury may weigh conflicting evidence and
certify as adjudicative (although not scientific) fact that which it bei;<*ves is more
likely" than not. Since Rctierve Mining was adjudicated in court, this standard applied to
the court's fact-finding. Inherently, such a standard is flexible ; inherently, it allows
tlie fact-finder to assess risks, to measure probabilities, to make subjective judgments.
Nonetheless, the ultimate finding will be treated, as law. as fact and will be affirmed if
based on substantial evidence, or if made by a judge, not clearly erroneous.

The standard before administrative agencies is no less flexible. Agencies are not limited
to scientific fact, to 95 percent certainties. Rather, they have at least the same fact-
finding powers as a jury, particularly when, as here, they are engaged in rule-making.

Looking to the future, and commanded by Congress to make policy, a rule-making
agency necessarily deals less with "evidentiary" disputes than with normative conflicts,
projections from imperfect data, experiments and simulations, educated predictions, differ-
ing assessments of possible risks, and the like.

Adwco Oil Co. V. EPA. supra note 2, 16.S U.S. App.D.C. at 175, 501 F.2d at 735. An
agencv's finding of fact differs from that of a jury or trial judge primarily in that it is
accorded more deference by a reviewing court. Flee note 74 infra. Thus, as a matter of
administrative law. the Administrator found as fact that lead emissions "will endanger"
the public health. That in so doing he did not have to rely solely on proved scientific fact
is inherent in the requirements of legal fact-finding. Petitioners' assertions of the need
to rely on on "fact" confuse the two terminologies. We must deal with the terminology
of law. not science. At law, unless the administrative or judicial task is peculiarly factual
in nature, or Congress expressly commands a more rigorous finding, see 21 TT.S.C. § ,355 (d) :
cf. pages 4,3-45 supra, assessment of risks as herein described typifies both the admin-
istrative and the judicial fact-finding function, and is not the novel or unprecedented
theory that petitioners contend.

262

wildest speculation. We have always thought scientific conclusions, above all,
demanded proof by events recorded and observed.

The court's second asserted dichotomy, risks versus facts, is equally indefensi-
ble in logic. All true risk assessment is based on fact and nothing else. Those
professional risk-assessors, the professional sports gambling fraternity, would
smile at any other theory. To the extent that a hunch and intuition enter into
any final decision, these are separate factors outside of any scientific risk
calculation.

Our colleagues apparently find it necessary to legitimatize the Administrator
playing hunches. They assert, "Danger is a risk, and so must be decided by as-
sessment of risk as well as by proof of facts." Of course the Administrator as-
sesses risk — from the facts as he knows them. The question here is how much
he knows. To the extent the agency found it necessary to make an "assessment of
risk as well as [rely on] proof of facts," the agency was frankly just speculat-
ing. No reviewing court can countenance this. If such agency decision is not
"arbitrary and capricious," what decision could be? It is precisely a devotion of
facts, not hunches, that distinguishes the professionals from the amateurs in
assessing risks ; we deem the Administrator to have been intended by Congress
to be a "professional."

Geoege Costello,
Legislative Attorney.

Mr. Baker. Mr. President, American society has just recently re-
alized the pervasiveness of the toxic chemical problem. The public is
being exposed to substances that are potentially toxic during normal
daily activities.

Our present pollution laws do no guard effectively against this
threat until these substances are already present in the environment.
Government regulatory agencies in general have no authority to pre-
vent exposure until after the substances have been manufactured and
are in use.

The measure before us today is an innovative legislative effort to
evaluate and control these substances before they have a chance to be-
come a problem.

The bill provides a mechanism to evaluate these elements prior to
production, thus halting the chain of events before it is started. It is
hoped that this preventive action will yield an opportunity to the con-
sumer, who has no resources to judge the long-range consequences of
these chemicals This creates a mechanism to sort out the risks and
benefits of these substances before harmful exposure.

But while this regulatory approach is generally sound, it carries with
it the potential for excessive administrative regulation and delay. It
is imperative that this legislation not become a tool for causing un-
necessary redtape for industry or government.

The premarket screening process [Sec. 5] which is the key to this
bill should not be used to cause unnecessary extensive testing in ad-
vance of commercial production, preventing production of many
needed products. This creates a heavy responsibility on those who ad-
minister this act. Care must be taken to assure that the responsibility
is carried out with fairness, not an overzealous use of administrative
powers.

*******
The Presiding Officer. All time having been yielded back, the ques-
tion is. Shall the bill pass ?

The yeas and nays have been ordered, and the clerk will call the
roll.

263

The assistant legislative clerk called the roll.

Mr. Robert C. Byrd. I announce that the Senator from Indiana (Mr.
Bayh), the Senator from Texas (Mr. Bentsen) , the Senator from Mis-
sissippi (Mr. Eastland), the Senator from Alaska (Mr. Gravel), the
Senator from Michigan (Mr. Philip A. Hart), the Senator from Colo-
rado (Mr. Haskell), the Senator from Hawaii (Mr. Inouye), the Sen-
ator from Washington (Mr. Jackson), the Senator from Wyoming
(Mr. McGee), the Senator from New Hampshire (Mr. Mclntyre), the
Senator from New Mexico (Mr. Montoya), the Senator from Utah
(Mr. Moss), the Senator from Mississippi (Mr. Stennis), and the
Senator from Iowa (Mr. Culver) are necessarily absent.

I further announce that the Senator from Vermont (Mr. Leah}^),
and the Senator from Louisiana (Mr. Long) are absent on official
business.

I further announced that, if present and voting, the Senator from
Washington (Mr. Jackson), the Senator from Vermont (Mr. Leahy)
and the Senator from Iowa (Mr. Culver) would each vote ''yea."

Mr. Griffix. I announce that the Senator from Tennessee (Mr.
Brock), the Senator from Massachusetts (Mr. Brooke), the Senator
from New York (Mr. Buckley), the Senator fi-om Arizona (Mr.
Fannin), the Senator from Oregon (Mr. ILatfield), the Senator from
Nebraska (Mr. Hruska), the Senator from Nevada (Mr. Laxalt), the
Senator from Maryland (Mr. Matliias), the Senator from Pennsyl-
vania (Mr. Hugh Scott), the Senator from Virginia (Mr. Scott),
and the Senator from Connecticut (Mr. Weicker) are necessarily
absent.

I further announce that, if present and voting, the Senator from
Oregon (Mr. Hatfield), the Senator from Pennsylvania (Mr. Hugh
Scott), and the Senator from Connecticut (Mr. Weicker) would each
vote "yea.''

The result was announced — yeas 60, nays 13, as follows :

[Rollcall Vote No. 103 Leg.]
YEAS— 60

Abourezk

Glenn

Xunn

Allen

Griffin

l*ackwood

Baker

Hart, Gary

Pastore

Beall

Hartke

Pearson

Biden

Hathaway

Pell

Bumi)ers

Hollings

Percy

Burdick

Huddleston

Proxmire

Byrd, Harry F., Jr.

Humphrey

Randolph

Byrd, Robert C.

Javits

Ribicofif

Cannon

Johnston

Roth

Case

Kennedy

Schweiker

Chiles

Magnuson

Sparkman

Church

Mansfield

Stafford

Clark

McClellan

Stevens

Cranston

McGovern

Stevenson

Dole

Metcalf

Stone

Durkin

Mondale

Taft

Eagleton

Morgan

Talmadge

Fong

Muskie

Tunney

Ford

Nelson

Williams

264

NAYS— 13

Bartlett

Bellmon

Curtis

Domenici

Garn

Goldwater

Hansen

Helms

McClure

Symington

Thurmond

Tower

Young

Bayh

Bentsen

Brock

Brooke

Buckley

Culver

Eastland

Fannin

Gravel

NOT VOTING— 27

Hart, Philip A.

Haskell

Hatfield

Hruska

Inouye

Jackson

Laxalt

Leahy

Long

Mathias

McGee

Mclntyre

Montoya

Moss

Scott, Hugh
Scott, William L.
Stennis
Weicker

So the bill (S. 3149) was passed, as follows:

S. 3149

Be it enacted hp the Senate and House of Representatives of the United States

of America in Congress assembled,

SHORT TITLE AND TABLE OF CONTENTS

Section 1. This Act may be cited as the "Toxic Substances Control Act".
TABLE OF CONTENTS

Sec. 1. Short title and table of contents.

Sec. 2. Findings, policy, and intent.

Sec. 3. Definitions and exclusions.

Sec. 4. Testing of chemical substances and mixtures.

Sec. 5. Premarket notification of chemical substances.

Sec. 6. Regulation of chemical substances and mixtures.

Sec. 7. Imminent hazards.

Sec. S. Reporting and retention of information.
Sec. 9. Relationship to other Federal laws.

Sec. 10. Research, collection, dissemination, and utilization data.
Sec. 11. Inspections and subpoenas.
Sec. 12. Expo'-L.

Sec. 13. Entry into customs territory of the United States.
Sec. 14. Disclosure of data.
Sec. 15. Prohibited acts.
Sec. 16. Penalties.

Sec. 17. Specific enforcement and seizure.

Sec. 18. Pre-emption.

Sec. 19. Judicial review.

Sec. 20. Citizen's civil action.

Sec. 21. Citizen's petitions.

Sec. 22. National defense waiver.

Sec. 23. Employee protection.

Sec. 24. Studies.

Sec. 25. State demonstration programs.
Sec. 26. Administration of Act.
Sec. 27. Authorization for appropriations.
Sec. 28. Annual report.

FINDINGS, POLICY, AND INTEREST

Sec. 2. (a) Findings. — The Congress finds that —

(1) humans and the environment are being exposed to a large number of
chemical substances and mixtures each year ;

(2) among the many chemical substances and mixtures constantly being
developed and produced are some whose manufacture, processing, distribu-
tion in commerce, use, or disposal may cause or contribute to an unreasonable
risk of injury to health or the environment ; and

(3) the effective regulation of such chemical substances and mixtures in
interstate commerce necessitates the regulation of such chemical substances
and mixtures in intrastate commerce as well.

265

(b) Policy. — It is the policy of the United States that —

(1) adequate data should be developed with respect to chemical sub-
stances and mixtures concerning their effect on human health and the
environment and that such data development should be the responsibility of
those who manufacture and those who process such chemical substances and
mixtures ;

(2) adequate authority should exist to regulate chemical substances and
mixtures which cause or contribute to an unreasonable risk of injury to
health or the environment, and to take action with respect to chemical
substances and mixtures which are imminent hazards ; and

(3) authority over chemical substances and mixtures should be exercised
in such a manner as not to impede unduly or create unnecessary economic
barriers to technological innovation while fulfilling the primary purpose of
this Act to assure that such innovation and commerce in such chemical sub-
stances and mixtures do not cause or contribute to an unreasonable risk of
injury to health or the environment.

(c) INTENT OF Congress. — It is the intent of Congress that the Administrator
shall carry out this Act in a reasonable and prudent manner, and that the Admin-
istrator shall consider the environmental, economic, and social impact of any
action the Administrator takes or proposes to take under this Act.

DEFINITIONS AND EXCLUSIONS

Sec. 3. (a) Definitions. — As used in this Act :

(1) The term "Administrator" means the Administrator of the Environmental
Protection Agency.

(2) (A) Except as provided in subparagraph (B), the term "chemical sub-
stance" means —

(i) any organic or inorganic substance of a particular molecular identity
including a combination of .such substances occurring as a result of a chemi-
cal reaction, or

(ii) any element or uncombined radical.
(B) Such term does not include —

(i) any mixture,

(ii) any pesticide (as defined in the Federal Insecticide, Fungicide and
Rodenticide Act) when manufactured or distributed in commerce for use as
a pesticide,

(iii) tobacco or any tobacco product.

(iv) any source material, special nuclear material, or byproduct material
(as such terms are defined in the Atomic Energy Act of 1954 and regulations
issued under such Act ) .

(v) any article which, if sold by the manufacturer, would be subject to the
tax imposed by section 4181 of the Internal Revenue Code of 1954 (deter-
mined without regard to any exemptions from such tax provided by section
4182 or 4221 or any other provision of such Code) , and

(vi) (A) any substance found in or on any food, drug, cosmetic, or device
(as such terms are defined in section 201 of the Federal Food, Drug, and
Cosmetic Act) when manufactured or distributed in commerce for use in
or any such food, drug, cosmetic, or device, or (B> any substance produced
for research and development purposes and intended only for use in or on
any such food. drug, cosmetic, or device.

The term "food" as used in clause (vi) of this subparagraph includes poultry
and poultry products (as defined in sections 4(e) and 4(f) of the Poultry
Products Inspection Act), meat and meat food products (as defined in section
l(j) of the Federal Meat Inspection Act), and eggs and egg products (as defined
in section 4 of the Egg Products Inspection Act).

(3) The term "commerce" means trade, traffic, or transportation (A) between
a place in a State and any place outside of such State, or (B) which affects such
trade, traffic or transportation.

(4) The term "distribute in commerce" or "distribution in commerce" which
used to describe an action taken with respect to a chemical substance, or the
introduction or delivery for introduction into commerce of. the substance or
mixture; or to hold, or the holding of, the substance or mixture after its
introduction into commerce.

(5) The term "environment" includes humans and their environment, water,
atmosphere, and land and the interrelationships which exist among and between
these.

79-313 0 - 77 - 18

266

(6) The term "health and safety study" means any study of any effects of a
chemical substance or mixture on health or the environment, including epide-
miological studies, studies of occupational exposure to a chemical substance or
mixture, toxicological, clinical, and ecological studies of a chemical substance
or mixture, and any test performed pursuant to this Act.

(7) The term "manufacture" means to import, produce, or manufacture for
commercial purposes.

(8) The term "mixture" means any combination of two or more chemical sub-
stances if such substances (A) do not react chemically with each other and if
the combination is not the result of a chemical reaction, or (B) occur in nature.

(9) The term "new chemical substance" means any chemical substance not
included in the chemical substance list compiled and published under section
8(b).

(10) The term "process" means the preparation of a chemical substance or
mixture for distribution in commerce —

(A) in the same form or physical state, or in a different form or physical
state from that in which it was received by the person making such prepara-
tion, or

(B) as part of an article containing the chemical substance or mixture.

(11) The term "processor" means any person who processes a chemical sub-
stance or mixture.

(12) The term "standards for the development of test data" means a prescrip-
tion of —

(A) the—

( i ) health and environmental effects, and

(ii) type of information relating to toxicity, persistence, and other
characteristics w^hich relate to effects on health and the environment

for which test data for a chemical substance or mixture are to be developed
and any analysis that is to be performed on such data, and

(B) to the extent necessary to assure that such data are reliable and
adequate, the manner in which such data are to be developed, the specifica-
tion of any test protocol or methodology to be employed in the development
of data respecting such effects and characteristics, and such other require-
ments as are necessary to provide such assurance.

(13) The term "State" means any of the several States, the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the
Canal Zone, American Samoa, or the Trust Territory of the Pacific Islands.

(14) The term "United States", when used in the geographic sense, means all
the States.

(15) The term "unreasonable adverse effects on the environment" means any
unreasonable risk to man or to the environment taking into account the economic,
social, and environmental costs and benefits of the use of any chemical substance.

(b) Exclusions. — The Administrator may exclude from coverage of this Act
or any provision of this Act any chemical substance or mixture if the Admin-
istrator determines, by rule, that such substance or mixture does not present an
unreasonable risk of injury to health or the environment, except that any such
exclusion shall not apply to section 7 or 8(e). Any such rule shall (A) be
promulgated pursuant to the procedures specified in section 6(c) (2), (3), (4),
and (5) and (B) may be modified, amended, or revoked in accordance with the
requirements of this subsection and pursuant to the procedures specified in such
section 6(c) (2), (3), (4), and (5).

TESTING OF CHEMICAL SUBSTANCES AND MIXTURES

Sec. 4. (a) Testing Requirements. — If the Administrator finds that —

(l)(A)(i) the manufacture, processing, distribution in commerce, use,
or disposal of a chemical substance or mixture may present an unreasonable
risk of injury to health or the environment, or (ii) (I) that the manu-
facture, processing, distribution in commerce, use, or disposal of a chemical
substance or mixture may present significant human or environmental
exposure because it is or will be produced in substantial quantities or for
other reasons, and (II) that such substance or mixture may perhaps pre-
sent an adverse effect on health or the environment.

(B) there are insuflicient data or experience upon which the effects of
such manufacture, processing, distribution in commerce, use, or disposal
on health or the environment can reasonably be determined or predicted,
and

267

(2) in the case of a mixture, the effects which the mixture's manufacture,
distribution in commerce, processing, use, or disposal may have on health
or the environment may not be reasonably and more efficiently determined
or predicted by testing chemical substances which compromise the mixture :
the Administrator shall by rule require that testing be conducted on such
substance or mixture to develop data with respect to the health and environ-
mental effects for which there is an insufficiency of data or experience and
which are relevant to a determination that the manufacture, distribution in
commerce, processing, use, or disposal of such substance or mixture does or
does not contribute to an unreasonable risk of injury to health or the environ-
ment. Ill requiring tests under this subsection, the Administrator shall consider
the reasonably ascertainable costs and other l)urdens associated with conducting
such tests in light of the possible risks of injurj- to health or the environment
and shall publish the same in the Federal Register. The finding in paragraph
( 1) ( A ) ( ii) (II) shall be presumed if the Administrator has no reliable data
or exj)erience available to him concerning the chemical substance or mi-xture.
The linding in paragraph (l)(ii)(II) shall not be subject to judicial review
on any ground other than the fact that such finding was not made.

(b)(1) Testing Requu!iement Rule. — ,A rule under subsection (a) requiring
the testing of a chemical substance or mixture shall include —

(A) identification of the substance or mixture for which testing is
required.

(B) standards for the development of test data for such substance or
mixture, and

((') with respect to chemical substances which are not new chemical
substances a specification of the i)eriod (which period may not be of un-
reasonable duration) within which the persons required to conduct the
testing shall submit to the Administrator data developed in accordance with
the standards referred to in subparagraph (B). Such a rule may require the
submission of preliminary data during the period prescribed under sub-
paragraph (C).

(2) (A) The health and environmental effects for which standards for the
develoi)ment of test data may be prescribed include carcinogenesis, mutagenesis,
teratogenesis, behavioral disorders, cumulative or synergistic effects, and any
other effect which may cause or contribute to an unreasonable risk of injury
to health or the environment, and the characteristics of chemical substances
and mixtures for which such standards may be prescribed include persistence,
acute toxicity, .subacute toxicity, chronic toxicity, and any other characteristic
which may cause or contribute to such a risk of injury. The methodologies that
may be prescribed in such standards include epidemiology, serial, or hierarchical
tests : in vitro tests ; and whole animal tests.

(B) From time to time, but not less than once each 12 months, the Admin-
istrator shall review the adequacy of tlie standards for development of data
prescribed in rule.s under subsection (a) and shall, if necessary, institute pro-
ceedings to make appropriate revisions of such standards.

(3) (A) A rule under subsection (a) respecting a chemical substance or mix-
ture sliall require the persons described in subparagraph (B) to conduct tests
and submit data on such substance or mixture, except that the Administrator
may permit two or more of such per.sons to designate one such i)erson or a quali-
fied third party to conduct such tests and submit .such data on behalf of the
persons making the designation.

(B) Tlie following persons shall be vcquired to conduct tests and submit data
on a chemical substance or mixture .subject to a rule under sub.section (a) :

(i) Each person who manufactures or intends to manufacture such sub-
stance or mixture if the Administrator made a finding described in sub-
section (a)(1)(B) with respect to the manufacture of the substance or
mixture which such person is engaged in or intends to engage in.

(ii) Each person who processes or intends to process such .substance or
mixture if the Administrator made a finding described in subsection (a)
(1) (B) with respect to tlie processing of the substance which such person
is engaged in or intends to engage in.

(iii) Each person who manufactures or processes or intends to manu-
facture or process such substance or mixture if, with respect to the dis-

268

tribution in commerce, disposal or use of such substance or mixture manu-
factured or processed by such person, the Administrator made a finding
described in subsection (a)Q)(B).
(4) Rules issued under subsection (a) (and any amendment thereto or repeal
thereof) shall be promulgated pursuant to section 553 of title 5, United States
Code, except that in promulgating, amending, or repealing any such rule (A) the
Administrator shall give interested persons an opportunity for the oral presen-
tation of data, views, or arguments, in addition to an opportunity to make
written submissions ; and ( B ) a transcript shall be made of any oral presen-
tation.

(c) Exemption. — (1) Any person required l)y a rule under subsection (a) to
conduct tests and submit data on a chemical substance or mixture may apply
to the Administrator (in such form and manner as the Administrator shall pre-
scribe) for an exemption from such requirement.

(2) If, upon receipt of an application under paragraph (1), the Administrator
determines that —

(A) the chemical substance or mixture with respect to which such appli-
cation was submitted is equivalent to a chemical substance or mixture for
which data has been submitted to the Administrator in accordance with a
rule under subsection (a) or for which data is being developed pursuant
to such a rule, and

(B) submission of data by the applicant on such substance or mixture
would be duplicative of data which has been submitted to the Administrator
in accordance with such rule or w^hich is being developed pursuant to such
rule.

the Administrator shall exempt, in accordance with paragraph (3) or (4), the
applicant from conducting tests and submitting data on such substance or
mixture.

(3) (A) If the exemption of any person from the requirement to conduct tests
and submit test data on a chemical substance or mixture is granted on the
basis of the existence of previously submitted test data and if such exemption
is granted during the reimbursement period for such test data (as. prescribed
by subparagraph (B)), then (unless such i)erson and the persons referred to
in clauses (i) and (ii) agree on the amount and method of reimbursement) the
Administrator shall order the person granted the exemption to provide fair and
equitable reimbursement (in an amount determined under rules of the Admin-
istrator)^—

(i) to the person who previously submitted such test data, for a portion
of the costs incurred by such person in complying with the requirement to
submit such data, and

(ii) to any other person w^ho has been required under this subparagraph
to contribute with respect to such costs, for a portion of the amount such
person was required to contribute.

In promulgating rules for the determination of fair and equitable reimburse-
ment to the persons described in clauses (i) and (ii) for costs incurred with
respect to a chemical substance or mixture, the Administrator shall, after con-
sultation with the Attorney General and the Federal Trade Commission, consider
all relevant factors, including the effect on competition within the chemical
industry and the share of the market for such substance or mixture of the
r)erson required to provide reimbursement in relation to the share of such market
of the persons to be reimbursed. An order under this subparagraph for purposes
of judicial review shall be considered final agency action.

(B) For purposes of subparagraph (A), the reimbursement period for any
test dat^ for a chemical substance or mixture is a period —

(i) beginning on the date such data was submitted in accordance with a
rule promulgated under subsection (a ) , and

(ii) ending —

( I ) two years after the date referred to in clause ( i ) , or

(II) at the expiration of a period which begins on the date referred
to in clause (i) and is equal to the period w^hich the Administrator
determines was necessary to develop such data,

whichever is later.

(4) (A) If the exemption of any person from the requirement to conduct tests
and submit test data on a chemical subsatnce or mixture is granted on the basis
of the fact that test data is being developed by one or more persons pursuant to

269

a rule promulgated under subsection (a), then (unless such i>erson and the
persons referred to in clauses (i) and (ii) agree on the amount and method of
reinibursem^»nt ) the Administrator shall issue an order to the person granted
the exemption to provide fair and equitable reimbursement (in an amount
determined under rules of the Administrator) —

(ij to each such i)erson who is developing such test data, for a portion of
the costs incurred by each such person in complying with such rule, and

(ii) to any other person who has been required under this subparagraph
to contribute with respect to the costs of complying with such rule, for a
portion of the amount such i^erson was required to contribute.
In promulgating rules for the determination of fair and equitable reimbursement
to the persons described in clauses (i) and (ii) for costs incurred with respect
to a chemical substance or mixture, the Administrator shall, after consultation
with the Attorney General and the Federal Trade Commission, consider all
relevant factors, including the effect on comi)etition within the chemical industry
and the share of the market for such substance or mixture of the person required
to provide reimbursement in relation to the share of such market of the persons
to be reimbursed. An order under this subparagraph for purposes of judicial
review .sliall l)e considered final agency action.

(B) If an exemption is granted on the basis of the fact that one or more
persons are developing test data pur.suant to a rule promulgated under subsec-
tion (a> and if after such exemption is granted the Administrator determines
that no such i)erson has complie<l with such rule, the Administrator shall (i)
after providing written notice to the i>erson who holds sucli exemption and an
opportunity for a hearing, by order terminate such exemption, and (ii) notify
in writing such person of the requirements of the rule with respect to which
such exemption was granted.

('}) If a y)erson provides reimbursement pursuant to an order issued under
paragraph (3) (A) or (4) (A) in connection with an exemption from a rule
promulgated under subsection (a), such person may, subject to section 14, have
access to test data the submission or development of which was the basis for
such exemption.

. (d) Notice. — Uix)n the receipt of any test data pursuant to a rule under sub-
s-ection (a), the Admini.*<trator shall (subject to section 14) publish a notice of
the receipt of such data in the Federal Register and make the data available
to the public within 15 days of receipt. Each such notice shall (1) identify the
chemical substance or mixture for wliich data have been received; (2) list
the uses or intended uses of such substance or mixture and the information
required by the applicable .standards for the development of test data; and (3)
describe the nature of the test data developed.

(e) PRTOKITY liTST. — (1) (A) There is establi.shed a committee to make recom-
mendations to the Administrator resi>ecting the chemical substances and mix-
tures to which the Administrator should give priority consideration for the
promulgation of a rule under subsection (a). In making such a determination
with respect to any chemical substance or mixture, the committee shall consider
all relevant factors, including —

(i) the quantities in which the .substance or mixture is or will be
manufactured, •

(ii) the quantities in which the .substance or mixture enters or will enter
the environment,

(iii) the numl>er of i^ersons who are or will be exposed to the substance
or mixture in their places of employment and the duration of such exposure,

(iv) the extent to which humans are or will be exposed to the substance
or mixture.

(v) the extent to which the substance or mixture is closely related to a
chemical substance or mixture which is known to cause or contribute to
an unreasonable risk to health or the environment.

(vi) the existence of data concerning the effects of the substance or
mixture on health or the environment, and

(vii) the extent to which testing of the substance or mixture may result
in the development of data upon which the effects of the substance or
mixture on health or the environment can reasonably be determined or
predicted.

The recommendations of the committee shall be in the form of a list of chemical
substances and mixtures which shall be listed, either by individual substance or

270

mixture or by groups of substances or mixtures, in the order in which the com-
mittee determines the Administrator should take action under subsection (a)
with respect to the substances and mixtures. The committee shall jrive priority
attention in establishing such list to those chemical substances and mixtures
which are known or are suspected of causing or contributing to (i) cancer, (ii)
gene mutations, or (iii) birth defects.

(B) As soon as practicable but not later than nine months after the date of the
enactment of this Act, the committee shall publish in the Federal Register the
list required by subparagraph (A) together with the reasons for the committee's
inclusion of each chemical substance or mixture on the list. At least every 6
months after the publication of the list pursuant to the preceding sentence, the
committee shall make such revisions in the list as it determines to be necessary
and shall publish the list in the Federal Register with tbe committee's revisions
(if any) and the reasons for the revisions. Within the 12-month period beginning
on the date of the inclusion of a chemical substance or mixture on such a list the
Administrator shall with respect to such chemical substance or mixture either
(i) initiate a rulemaking proceeding under section 4(a) or (ii) if such a pro-
ceeding is not initiated within such period, publish in the Federal Register the
Administrator's reasons for not initiating such a proceeding.

(C) The Administrator may promulgate a rule under subsection (a) with re-
spect to a chemical substance or mixture (i) which is not contained on a list
published under this subsection or (ii) whether or the Administrator has pub-
lished in the Federal Register reasons for not initiating a proceeding under sub-
paragraph (B).

(2) (A) The committee established by paragraph (1) (A) shall consist of
seven members as follows :

(i) One member (or designee of the member) appointed from the Depart-
ment of Commerce by the Secretary.

(ii) One member (or designee of the member) appointed from the En-
vironmental Protection Agency by the Administrate".

(iii) One member (or designee of the member) appointed by the Secretary
of Labor from officers of the Department of Labor engaged in the Secretary's
activities under the Occupational Safety and Health Act of 1970.

(iv) One member (or designee of the member) appointed from the Coun-
cil on Environmental Quality by the Chairman of the Council.

(v) One member Cor designee of the member) appointed from the Na-
tional Institute for Occupational Safety and Health by the Director of the
Institute.

(vi) One member (or the designee of the member) appointed from the
National Institute of Environmental Health Sciences by the Director of the
Institute.

(vii) One member (or designee of the member) appointed from the Na-
tional Cancer Institute by the Director of the Institute.

(viii) One member (or designee of the member) appointed from the Na-
tional Science Foundation by the Director of the Foundation.

A member may designate an individual to serve on the member's behalf only
with the approval of the applicable appointing authority and only if the indi-
vidual is from the entity from which the member was appointed. A vacancy in
the committee shall be filled in the same manner in which the original appoint-
ment was made.

(B) (i) The term of office of a member of the committee is 4 years, except that
of the members first appointed, four members shall have initial terms of 2 years.
Any member appointed to fill a vacancy occurring prior to tiie expiration of the
term for which the member's predecessor was appointed shall be appointed only
for the remainder of such term. If any member of the commirtee leaves the office
or entity from which the member was appointed, such member's term of office
shall be terminated and the member's position shall be considered as being va-
cant. A member may serve after the expiration of tbe member's term of office
until a successor has taken office. Members may lie reappointed.

(ii) Initial appointments to the committee shall be made not later than the
60th day after the date of the enactment of this Act. Not later than the OOth day
after such date of enactment the members of the committee shall hold a meeting
for the selection of a chairman from among their number and to determine, by
lot, the four members who shall have initial terms of 2 years.

(C) (i) No member of the committee, or designee of such member, shall accept
employment or compensation from any person subject to any requirement of this

271

Act. or rules issued thereunder, for a period of at least 24 months after termina-
tion of employment with such agency.

(ii) No person, while serving as a member of such committee, or designee of
such member, may own any stocks or bonds, or have any pecuniary interest in
any firm, association, or corporation engaged in the manufacture, processing, or
distribution of ^ny chemical substance or mixture subject to the provisions of
this Act.

(iii) The Administrator or the Attorney General bring an action in the appro-
priate district court of the United States to restrain any violations of this
subparagraph.

(D) The Administrator shall provide the committee such administrative and
staff support services as may be necessary for the committee to carry out its
functions under this subsection.

(f ) Required Actions. — (1) Upon the receipt of (A) any test data required to
be submitted under this section or under section o. or (B) any other information
available to the Administrator which indicates that a chemical .substance or mix-
ture has the potential, at levels for which human exposure exists or may exist
and with appropriate safety margins, to induce in human beings (1 ) cancer. (2)
gene mutations, or (3) birth defects, the Administrator shall take appropriate
action under section 5(e), 6(a). or 7, within 180 days after the receipt of such
data or information to limit exposure of human beings with respect to such sub-
stance or mixture, or he shall publish in the Federal Register his findings that
no unreasonable risk of injury is i)resented and rea.sons therefor. Any such find-
ing under this subsection that nounreasonable ri.sk is presented shall be review-
able in accordance with chapter 7 of title 5. United States Code.

(2) Nothing contained in this subsection shall require the Administrator to
take action under section Hfe). 6(a). or 7, or publish his reasons for failing to
take such action, until 2 years after the date of enactment of this Act.

PREMARKET NOTIFICATION OF CHEMICAL SUBSTANCES

Sec. 5. (a) General. — (1) Commencing 1 year and 30 days after the date of
enactment of this Act, a manufacturer shall notify the Administrator, who shall
notify the public as required in subsection (c). of any planned manufacture of a
new chemical substance, at least 90 days prior to the commencement of such
manufacture. Such notice to the Administrator shall be accompanied by all
pertinent information referred to in section 8(a)(2), whether or not the Ad-
ministrator has required the submission thereof under section 8(a)(2), except
that with respect to the information referred to under section 8(a) (2) (E), such
manufacturer may submit a description of such information, as defined by the
Administrator, by rule.

(2) The Administrator shall give priority attention to a chemical substance
with respect to which information is received indicating that serious economic
or other hardships are likely to result if there is any delay in manufacture. If
the Administrator finds that such a substance does not present an unreasonable
risk to human health and the environment, he may reduce the number of days,
after submission of such information, during which manufacture may not occur.
The Administrator shall promptly publish (subject to .section 14) his findings and
the basis therefor in the Federal Register.

(b) Submission of Data. — Any manufacturer of a new chemical substance
that is covered by section 4(a) shall submit to the Administrator (in addition to
the information required in subsection (a) the data developed in accordance
with such requirement at least 90 days prior to such manufacture, and the
Administrator shall make it publicly available in accordance with subsection (c).

(c) Data Availability. — "Within 15 days after receipt, the Administrator shall
promptly publish in the Federal Register (subject to section 14) the identity of
each chemical substance for which a notice has been received under subsection
(a) or (b). the intended use or distribution of such substance, and a statement
that the data and other information is available. The 90 days referred to in sub-
sections (a) and (b) shall begin upon publication under this sub.section in the
Federal Register.

(d) Extension. — The Administrator may extend, for an additional period
beyond the 90-day period referred to in subsection (a) or (b). the date after
which a new chemical substance may be manufactured. Such additional period
may not exceed 90 days and shall not be imposed except for good cause .shown.
Notice of any such extension, and the reasons therefor, shall be published (sub-

272

ject to section 14) in the Federal Register. Such an extension shall constitute a
final action for purposes of judicial review.

(e) Orders. — (1) (A) If the Administrator finds, during the 90-day period
referred to insubsection (a) or (b) or during any extension thereof, with
resi^ect to any new chemical substance for which notification is required under
this section —

(i) that such new chemical substance is covered by a test requirement
under section 4(a), but that such requirement requires additions or re-
visions with respect to such substance ; or

(ii) that such new^ chemical substance is not covered by such a require-
ment under section 4(a), but that such requirement should be established;
he shall issue an order in accordance with this subsection. Such an order
shall appropriately prohibit or restrict the manufacture, processing, distri-
bution in commerce, use, or disposal of such new chemical substance pend-
ing the completion of a rulemaking proceeding under section 4(a) and the
submission of any data required thereunder, as described under subpara-
graph (B) ; shall contain a proposed rule under section 4(a) ; and shall be
immediately effective.

(B) Upon the issuance of any order under subparagraph (A), the Adminis-
trator shall proceed with a rulemaking procedure as expeditiously as practicable
under section 4(a) and in accordance with subparagraph (C). During the course
of, or upon the completion of, such rulemaking, the Administrator shall, if neces-
sary, appropriately modify or rescind any order issued under subparagraph (A).
If any testing requirements are established as a result of such rulemaking, any
provision of such order restricting the manufacture, processing, distribution in
commerce, use, or disposal of such substance shall remain in effect, unless modi-
fied or rescinded, pending the submission of such data to the Administrator and
the completion of procedures described in subsection (b) or any extension
imposed under subsection (d).

(C) If the Administrator issues an order under subparagraph (A), the Ad-
ministrator shall provide interested persons reasonable opportunity, in accord-
ance with section 4(b) (4) to make presentations and submissions mth respect
to such order. If such presentation or submission is requested, the Administrator
shall comply within 30 days from the date such request is made unless the
Administrator and the person making the request agree upon a later date.
Within 10 days after such presentations and submission are concluded, the
Administrator shall consider such presentations and submissions and aflirm,
modify, or revoke such order.

(2) (A) If the Administrator finds, during the 90-day period referred to in
subsection (a) or (b) or during any extension thereof, with respect to any new
chemical substance for which notification is required under this section, that a
rule is appropriate under section 6(a). he shall issue an order in accordance
with this subsection. Such an order shall appropriately prescribe such require-
ments as are authorized under section 6(a) : shall contain a proposed rule under
section 6(a) ; and shall be immediately effective.

(B) Upon the issuance of any order under subparagraph (A), the Adminis-
trator shall proceed with a rulemaking procedure as expeditiously as practicable
under section 6(a) and in accordance with subparagraph (C). During the course
of, or upon the completion of such rulemaking, the Administrator shall, if neces-
sary, appropriately modify or rescind any order issued under subparagraph (A).

(C) If the Administrator issues an order under subparagraph (A), the Ad-
ministrator shall provide interested persons reasonable oi)portunity, in accord-
ance with section 6(c) (2) and (3) for an informal hearing with respect to such
order. If such hearing is requested, the Administrator shall comply within 30
days from the date such request is made unless the Administrator and the per-
son making the request agree upon a later date. Within 10 days after such hear-
ing is concluded, the Administrator shall consider the information presented at
such hearing and aflBrm, modify, or revoke such order.

(f ) Statement of Reasons for Not Taking Action. — Prior to the expiration
of 90 days after the date of publication under subsection (c), of data and infor-
mation with respect to a new chemical substance, or prior to the expiration of
such i)eriod as extended under subsection (d), the Administrator shall publish
a statement of his reasons in the Federal Register, if he decides not to take
action under subsection (e) or section 7 with respect to such chemical substance
during such period. Manufacture may commence following publication of the

273

Administrator's statement. The Administrator's failure to issue such an order
under subsection (e) or take action under section 7 is an action subject to
judicial review in accordance with section 19. Nothing in this subsection pro-
hibits the Administrator from —

(1) promulgating a rule pursuant to section 6 or 4, with respect to such
a substance, after such manufacture has commenced ;

(2) taking action against any chemical substance which is found to be an
imminent hazard pursuant to section 7 ; or

(3) taking any other action authorized by this Act.

(g) Exemption. — (1) The Administrator may upon application (made in such
form and manner as the Administrator may prescribe) exempt any i)erson from
the requirement of subsection (b) or (h) to submit data for a chemical sub-
stance or mixture. If, upon receipt of an application under the preceding sen-
tence, the Administrator determines that —

(A) the chemical substance or mixture with resi)ect to which such ap-
plication was submitted is equivalent to a chemical substance or mixture
for which data has been submitted to the Administrator in accordance with
subsection (b) or (h), and

(B) submission of data by the applicant with respect to such substance
would be duplicative of data which has been submitted to the Administrator
in accordance with such subsection,

the Administrator shall exempt the applicant from submitting such data with
respect to such substance. No exemption granted under this subparagraph with
respect to the submission of data for a chemical substance or mixture may take
effect before the beginning of the reimbursement period applicable to such data.

(2) If the Administrator, under paragraph (1), exempts any i>erson from sub-
mitting under subsection (b) or (h) data for a chemical substance or mixture
because of the existence of previously submitted data and if such exemption is
granted during the reimbursement period for such data, then (unless such per-
son and the T)ersons referred to in subparagraphs (A) and (B) agree on the
amount and method of reimbursement) the Administrator shall order the i^erson
granted the exemption to provide fair and equitable reimbursement (in an
amount determined under the rules of the Administrator) —

(A) to the person who previously submitted the data on which the ex-
emption was based, for a portion of the costs incurred by such person in
complying with the requirement under subse<*tion (b) or (h) to submit
such data, and

(B) to any other person who has been required under this subparagraph
to contribute with respect to such costs, for a portion of the amount such
person was required to contribute.

In promulgating rules for the determination of fair and equitable reimbursement
to the persons described in subparagraphs (A) and (B) for costs incurred with
respect to a chemical substance or mixture, the Administrator shall, after con-
sulting with the Attorney General and the Federal Trade Commission, consider
all relevant factors, including the effect on c.omx)etiti()n within the chemical
industry and the share of the market for such substance or mixture of the person
required to provide reimbursement in relation to the share of such market of the
persons to be reimbursed. An order under this subparagraph shall be considered
final agency action, for purposes of judicial review.

(3) For puri)Oses of this paragraph, the reimbursement period for any
previously submitted data for a chemical substance or mixture is a period —

(A) beginning on the date of the termination of the prohibition, imposed
under this section, on the manufacture or processing of such substance by
the person who submitted such data to the Administrator, and

(B) ending —

(i) two years after the date referred to in subparagraph (A), or

(ii) at the expiration of a period which begins on the date referred
to in subparagraph (A) and is equal to the period which the Adminis-
trator determines was necessary to develop such data,

whichever is later.

(h) Significant New Use. — (1) Within 0 months after the date of enact-
ment of this Act, and from time to time thereafter, tlie Administrator shall, by
rule, estabHsh criteria defining a significant new distribution in commerce,
use, or disposal of a chemical substance. In establishing such criteria the Ad-
ministrator shall take into account —

(A) projected volume of production ;

274

( B ) projected category or categories of uses ;

(D) route or routes of exposure of human beings or of the environment
that are attributable to such significant new use : and

( E ) the human health and environmental effects thereof.

(2) A chemical substance may not be manufactured or processed for a dis-
tribution in commerce use, or disposal that is identified by the Administrator,
in a rule, as a significant new distribution in commerce, use, or disposal, unless,
at least 90 days prior to such manufacture or processing, the i^erson intending
to manufacture or process such substance for such distribution in commerce,
use, or disposal submits a notice of his intention to do so and any data required
to be develoi>ed under section 4(a) to the Administrator. Any such use of such
substance shall be subject to all of the provisions of this section.

(i) Special Exemption, — The Administrator may, upon application and by
rule, exempt any person from the foregoing requirements of this section —

(1) for the purpose of permitting such person to manufacture, process,
distribute in commerce, use, or dispose of a new chemical substance to which
a rule under section (a) is applicable for test marketing purposes or
specially limited purposes (A) upon a showing by such person that such
activity will not cause or contribute to an imreasonable risk of injury to
human health or the environment, and (B) under such restrictions as the
Administrator considers appropriate ; or

(2) to the extent that such person manufactures chemical substances
which are intermediate reaction products formed during the manufacture
of other chemical substances and for which there is no exposure to human
beings or the environment.

(j) MixTiTtES. — The Administrator is authorized to specify any mixture
which shall be subject to the provisions of this section.

(k) Experimentation. — The requirements of subsections (a), (b), and (h)
do not apply to any chemical substance which is manufactured or intended to
be manufactured only in small quantities (as defined by the Administrator by
rule) solely for scientific experimentation or analysis or for chemical research
or analysis, including such research or analysis for the development of a prod-
uct, except that the Administrator may, by rule, include such chemical sub-
stances upon a finding that the manufacture, processing, distribution in
commerce, use, or disposal of such chemical substances may cause or contribute to
an unreasonable risk of injury to human health or the environment.

REGULATION OF CHEMICAL SUBSTANCES AND MIXTURES

Sec. 6. (a) Scope of Regulation. — (1) If the Administrator finds that the
manufacture, processing, distribution in commerce, use, or disposal of a chemical
substance or mixture presents or is likely to present an unreasonable risk of
injury to health or the environment, the Administrator shall by rule apply to
such substance or mixture one or more of the following requirements as is
necessary to adequately protect against such risk using the least burdensome of
effective controls :

(A) A requirement prohibiting processing or distribution in commerce of
such substance or mixture or limiting the amount of such substance or mixture
which may be manufactured, processed, or distributed in commerce.

(B) A requirement —

(I) prohibiting the manufacture, processing or distribution in commerce
of such substance or mixture for (i) a particular use or particular uses or
(ii) a particular use or particular uses in a concentration in excess of a
level specified by the Administrator in the rule imposing the requirement,
or

(II) limiting the amount of such substance or mixture which may be
manufactured, processed, or distributed in commerce for (i) a particular
use or particular uses or (ii) a particular use or particula uses in a con-
concentration in excess of a level specified by the Administrator in the rule
imposing the requirement.

(D) A requirement that such substance or mixture or any article containing
such substance or mixture be marked with or accompanied by clear and adequate

275

warnings and instructions with respect to its distribution in commerce, use, or
disposal. The form and content of such warnings and instructions shall be pre-
scribed by the Administrator.

(E) A requirement directing manufacturers or processors of such substance
or mixture (i) to give notice of such unreasonable risk of injury to distributors
in commerce of such .substance or mixture and, to the extent reasonably ascer-
tainable, to other i^rsons in possession of such substance or mixture or exposed
to such substance or mixture, (ii) to give public notice of such risk of injury,
and (iii) to either replace or repurchase such substance or mixture whichever
the pers(m to which the requirement is directed elects.

(F) A requirement that manufacturers and processors of such substance or
mixture make and retain records of the processes used to manufacture or proc-
ess such substance or mixture and monitor or conduct tests which are reason-
able and necessary to assure compliance with the requirements of this subsection.
A requirement imi)Osed under this subsection may be limited in application to
specified geographic areas.

(2) Rules limiting the amount of a chemical substance or mixture which
may be manufactured, processed, or distributed in conmierce, or limiting, the
amount of such substance which may be manufactured, processed, or dis-
tribute<l for a particular use shall, upon the i)etition of any manufacturer, proc-
essor, or distributor in commerce thereof, provide for assigning production,
processing, and distribution quotas, to the extent necessary with respect to the
chemical substance involved. The i)ermi.ssible quota for each person who ap-
plies to manufacture, process, or import such substance or to engage in its
distribution in commerce shall be determined in accordance with fair and equit-
able criteria which the Secretary of Coinmerce. in consultation with the Ad-
ministrator and the Attorney General, shall prescribe by rule. Such criteria
shall take into account all relevant factors, including ( A ) effects on competition ;
(B) the market shares, productive capacity and product and raw material in-
ventories of the precursors of the chemical substance or mixture of persons
applying for quotas : (C) emergency conditions : and (D) effects on technological
innovation.

(3) (A) Prior to the issuance of a quota under paragraph (2) the persons who
apply under such paragraph shall attempt to develop a voluntary agreement
limiting the quantities which each such person .shall manufacture, process, im-
port, or distribute. The availability of immunity from the antitrust laws with
respect to the development of such voluntary agreement shall be limited to the
provisions of this subsection.

(B) The Secretary of Commerce, with the approval of the Attorney General,
after each of them has consulted with the Federal Trade Commission, shall pre-
scribe, by rule, .standards and procedures by which persons .seeking to manu-
facture, process, import, or other\\ise distribute a chemical substance or mixture
for which limitations on quantity have been prescribed pursuant to paragraph
(B)(II) of subsection (a) of this section may develop and carry out such
voluntary agreements as are permissible pursuant to this subsection.

(i) Meetings held to develop or carry out a voluntary agreement under this
subsection shall permit attendanc-e by repre.sentatives of Committees of Con-
gress and interested i)ersons. including all i>ersons interested in the chemical
substance or mixture involved, and the public : shall be preceded by timely and
adequate notice with identification of the agenda of such meeting to the Secre-
tary of Commerce, the Attorney General, the P>deral Trade Commission, the
Administrator and the public; and .shall be chaired by a regular full-time Federal
employee.

(ii) A full and complete record, and where practicable a verbatim trans-
cript, shall be kept of any meeting held, and a full and complete record shall be
kept of any communication (other than in a meeting) made, between or among
participants or potential participants, to develop, or carry out a voluntary
agreement under this subsection. Such record or transcript shall be deposited,
together with any agreement resulting therefrom, with the Secretary of Com-
merce and the Administrator and shall be available to the Attoney General and
the Federal Trade Commission. Such records or transcripts shall be available
for public inspection and copying in accordance with section 552 of title 5, United
States Code.

276

(D) (i) The Attorney General and the Federal Trade Commission shall par-
ticipate from the beginning in the development, and when practicable, in the
carrying out of voluntary agreements and plans of action authorized under this
section. Each may propose any alternative which would void or overcome, to
the greatest extent practicable, possible anticompetitive effects while achieving
substantially the purpose of this subsection. A voluntary agreement under this
subsection may not be carried out unless approved by the Attorney General,
after consultation with the Federal Trade Commission. Prior to the expiration
of the 20-day period prescribed under clause ( ii ) , the Federal Trade Commission
shall transmit to the Attorney General its views as to whether such an agree-
ment or plan of action should be approved, and shall publish such views in the
Federal Register. The Attorney General, in consultation with the Federal Trade
Commission, and the Secretary, shall have the right to review, amend, modify,
disapprove, or revoke, on his own motion or upon the request of the Federal
Trade Commission or any interested i)erson, any voluntary agreement at any
time, and, if revoked, thereby withdraw prospectively any immunity which may
be conferred by subparagraphs ( F ) or ( 1 ) .

(ii) Any voluntary agreement entered into pursuant to this section shall be
submitted in writing to the Attorney General and the Federal Trade Commis-
sion 20 days before being implemented. Any such agreement shall be available for
public inspection and copying, to the extent to which records or transcripts are so
available as provided in the last sentence of subparagraph (C) (ii). Any action
taken pursuant to such voluntary agreement or plan of action shall be reported
to the Attorney General and the Federal Trade Commission pursuant to such
regulations as shall be prescribed under clauses (iii) and (iv) of subparagraph
(E).

(E) (i) The Attorney General and the Federal Trade Commission shall
monitor the development and carrying out of voluntary agreements authorized
under this paragraph in order to promote competition and to prevent anticom-
petitive practices and effects.

(ii) In addition to any requirement specified under subparagraphs (B) and
(C) of this paragraph and in order to carry out the purposes of this section,
the Attorney General, in consultation with the Federal Trade Comnaission and
the Administrator, shall promulgate rules concerning the maintenance of neces-
sary and appropriate records related to the development and carrying out of
voluntary agreements authorized pursuant to this section.

(iii) Persons developing or carrying out voluntary agreements authorized
pursuant to this section shall maintain such records as are required by rules
promulgated under subparagraph (B). The Attorney General and the Federal
Trade Commission shall have access to and the right to copy such records at
reasonable times and upon reasonable notice.

(iv) The Attorney General and the Federal Trade Commission may each pre-
scribe such rules as may be necessary or appropriate to carry out their respective
responsibilities under this section. They may both utilize for such purposes and
for purposes of enforcement any powers conferred upon the Federal Trade Com-
mission or the Department of Justice, or both, by the antitrust laws or the Anti-
trust Civil Process Act ; and wherever any such law refers to "the puriyoses of
this Act" or like terms, the reference shall be understood to include this
subsection.

(F) (i) There shall be available as a defense to any civil or criminal action
brought under the antitrust laws (or any similar State law) in respect to actions
taken to develop or carry out a voluntary agreement by persons engaged in the
business of manufacturing, processing, or distributing such chemical substance
or mixture (provided that such actions were not taken for the purpose of in-
juring competition) that —

(I) such actions were taken in the course of developing a voluntary agree-
ment pursuant to this paragraph to carry out a voluntary agreement author-
ized and approved in accordance with this section, and

(II) such persons complied with the requirements of this paragraph and
the rules promulgated hereunder.

(ii) Persons interposing the defense provided by this paragraph shall have
the burden of proof, except that the burden shall be on the person against whom
the defense is asserted with respect to whether the actions were taken for the
purpose of injuring competition. .

(G) No provision of this section shall be construed as granting immunity for,
or as limiting or in any way affecting any remedy or penalty which may result

277

from any legal action or proceeding arising from, any act or practice which
occurred prior to the date of enactment of this Act or subsequent to its expira-
tion or repeal..

(H) The Attorney General and the Federal Trade Commission shall each sub-
mit to the Congress and to the President, at least once each year a report on the
impact on competition and on small business of actions authorized by this
section.

(I) In any action in any Federal or State court for breach of contract, there
shall be available as a defense that the alleged breach of contract was caused
predominantly by action taken to carry out a voluntary agreement authorized
and approved in accordance with this paragraph.

(J) As used in this paragraph, the term "antitrust laws" includes —

(i) the Act entitled "An Act to protect trade and commerce against un-
lawful restraints and monopolies", approved July 2, 1890 ;

(ii) the Act entitled "An Act to supplement existing laws against unlaw-
ful restraints and monopolies, and for other purposes", approved October
15, 1914 ;

(iii) the Federal Trade Commission Act ;

(iv) section 73 and 74 of the Act entitled "An Act to reduce taxation, to
provide revenue for the Government, and for other purposes", approved
August 27, 1894 : and

(v) the Act of June 19, 1936. chapter 592.

(b) Quality Control. — (1) If the Administrator has good cause to believe
that a particular manufacturer or processor is manufacturing or processing a
chemical substance or mixture in a manner which causes the adulteration of a
chemical substance or mixture —

(A) the Administrator may by order require such manufacturer or proc-
essor to submit a description of the relevant quality ond control procedures
followed in the manufacturing or processing of such chemical substance or
mixture ; and

(B) if the Administrator thereafter determines on the record, after op-
portunity for hearing in accordance with section 554 of title 5, Ignited States

. Code, that such quality control procedures are inadequate to prevent the
chemical substance or mixture from causing or contributing to such risk, the
Administrator may order the manufacturer or processor to revise such
quality control procedures to the extent necessary to remedy such
inadequacy.

(2) As used in this section, a chemical substance or mixture is adulterated if
the manner in which it is manufactured or processed causes it to contain a par-
ticular molecular identity, an uncombined radical, an element, or any combina-
tion thereof, which is found by the Administrator to cause or contribute to an un-
reasonable risk of injury to human health or the environment.

(c) Promutxjation of Subsection (a) Rules. — (1) In promulgating any rule
under sub.section (a) with respect to a chemical substance or mixture, the Ad-
ministrator shall consider relevant factors and make findings with respect
thereto, including —

(A) the risks presented by .such substance or mixture to health and the
magnitude of human exi>osure to such substance or mixture.

(B) the risks presented by such substance or mixture to the environment
and the magnitude of environmental exposure to such substance or mixture.

(C) the benefits of such substance or mixture for such use or uses and the
availability of other substances or mixtures for such use or uses, and

(D) the reasonably ascertainable economic consequences of the rule, in-
cluding consideration of the effect on the national economy, innovation, the
environment, and public health.

Findings made under this paragraph shall be published in the Federal Register.

(2) When prescribing a rule under subsection (a) the Administrator shall
proceed in accordance with section 553 of title 5, United States Code (without
regard to any reference in such section to sections 556 and 557 of such title),
and shall also (A) publish a notice of propo.sed rulemaking stating with par-
ticularity the reason for the proposed rule: (B) allow interested persons to sub-
mit written data, views, and arguments, and make all such submissions publicly
available; (C) provide an opportunity for an informal hearing in accordance
with paragraph (3) : and (D) promulgate, if appropriate, a final rule based on
the matter in the rulemaking record.

278

(3) The Administrator shall conduct informal hearings required by paragraph
(2) (C) of this subsection in accordance with the following procedure:

(A) Subject to paragraph (B) of this paragraph, an interested person
is entitled —

(i) to present his position orally or by documentary submissions (or
both ) , and

(ii) if the Administrator determines that there are disputed issues of
material fact it is necessary to resolve, to present such rebuttal submis-
sions and to conduct (or have conducted under subparagraph (B)(ii))
such cross-examination of persons as the Administrator determines (I) to
be appropriate, and (II) to be required for a full and true disclosure with
respect to such issues.

(B) The Administrator may prescribe such rules and make such rulings con-
cerning proceedings in such hearings to avoid unnecessary costs or delay. Such
rules or rulings may include (i) imposition of reasonable time limits on each in-
terested person's oral presentations, and (ii) requirements that any cross-ex-
amination to which a person may be entitled under subparagraph (A) be con-
ducted by the Administrator on behalf of that person in such manner as the
Administrator determines (I) to be appropriate, and (II) to be required for a
full and true disclosure with respect to disputed issues of material fact.

(C) (i) Except as provided in clause (ii), if a group of persons each of whom
under subparagraphs (A) and (B) would be entitled to conduct (or have con-
ducted) cross-examination and who are determined by the Administrator to have
the same or similar interests in the proceeding cannot agree upon a single repre-
sentative of such interests for purposes of cross-examination, the Administrator
may make rules and rulings (I) limiting the representation of such interest for
such purposes, and (II) governing the manner in which such cross-examination
shall be limited.

(ii) When any person who is a member of a group with respect to which the
Administrator has made a determination under clause (i) is unable to agree
upon group representation with the other members of the group, then such per-
son shall not be denied under the authority of clause (i) the opportunity to con-
duct (or have conducted) cross-examination as to issues affecting his particular
interests if (I) he satisfies the Administrator that he has made a reasonable and
good faith effort to reach agreement upon group representation with the other
members of the group and (II) the Administrator determines that there are
substantial and relevant issues which are not adequately presented by the group
representative.

(D) A verbatim transcript shall be taken of any oral presentation, and cross-
examination, in informal hearings under this subsection. Such transcript shall
be available to the public.

(E) A substantive amendment to, or repeal of, a rule promulgated under
subsection (a) shall be prescribed, and subject to judicial review, in the same
manner as a rule prescribed under such subsection.

(4) Any rule promulgated under this section shall be judicially reviewable in
accordance with section 19, except that in addition to any basis for holding un-
lawful or setting aside the rule under subparagraphs (A), (B), (C), or (D) of
section 706(2) of title 5. United States Code, the court shall hold unlawful and
shall set aside the rule if the court finds that —

(A) the Administrator's determination under paragraph (3) that the
petitioner is not entitled to conduct cross-examination or make rebuttal sub-
missions, or

(B) the Administrator's rule or ruling under paragraph (3) limiting the
petitioner's cross-examination or rebuttal submissions, has precluded dis-
closure of disputed material facts which was necessary for fair determina-
tion by the Administrator of the rulemaking proceeding taken as a whole.

(5) (A) The Administrator may pursuant to rules prescribed by him, provide
compensation for reasonable attorneys fees, expert witness fees, and other costs
of participating in a rulemaking proceeding under this section to any person
(i) who has. or represents an interest (I) which would not otherwise be ade-
quatelv represented in such proceeding and (II) representation of which is nec-
essarv" for a fair determination of the rulemaking proceeding taken as a whole,
or (ii) who is unable effectivelv to participate in such proceeding because such
person cannot afford to pay costs of making oral presentations, conducting cross-
examination, and making rebuttal submission in .such proceeding.

(B) The aggregate amount of compensation paid to all persons in any fiscal
year under this subsection may not exceed $1,(X)0,000.

279

(d) Effective Date. — (1) The Administrator shall specify in any rule under
'•section (a) the date on which it shall take effect, which date shall be as

11 as feasible.

(2) Section 553(b) (B) of title 5, United States Code, shall be applicable to
rules issued under subsection (a) notwithstanding any requirement of subsec-
tion (c) (2) or (3) in those situations where compliance with the requirements
of subsection (c) (2) or (3) would present an unreasonable risk of death,
serious or substantial personal injury (including illness) or serious or substan-
tial environmental harm.

(e) PcLYCHLORiNATED BiPHENYLs. — (1) Effective 1 year after the date of en-
actment of this Act, it shall be unlawful to manufacture, process distribute in
commerce, or use any polychlorinated biphenyl in any manner other than in a
totally enclosed manner, except that the Administrator may, by rule promul-
gated in accordance with subsection (c) (2), authorize the manufacture, proc-
essing, distribution in commerce, or use of any polychlorinated biphenyl in other
than a totally enclosed manner if the Administrator finds that no unreasonable
risk of injury to health or the environment is presented.

( 2) Effective 2 years after the date of enactment of this Act, it shall be unlaw-
ful to manufacture any polychlorinated biphenyl, and effective 2i/^ years after
such date, it shall be unlawful to process or distribute in commerce any poly-
chlorinated biphenyl, except that the Administrator may authorize, by rule pro-
mulgated in accordance with subsection (c)(2), such manufacture, processing,
or distribution in commerce after such time period if the Administrator finds
that no imreasonable risk of injury to health or the environment is presented.

(3) Within 6 months after the date of enactment of this Act, the Administra-
tor shall promulgate rules under subsection (a) which shall (A) prescribe
methods for the disposal of polychlorinated biphenyls in accordance with the
requirements of that subsection and (B) specify the manner in which polychlo-
rinated biphenyls shall be marked with clear and adequate warnings and in-
structions with respect to their processing, distribution in commerce, use, or
disposal. Any such rules shall be consistent with the requirements of paragraphs
(1 ) and (2) of this subsection or rules issued thereunder.

(4) For the purposes of this subsection, the term "totally enclosed manner"
means any manner which will ensure that any leakage of a polychlorinated bi-

I phenyl from its enclosure will be insignificant, as defined in rules of the
! Administrator.

i IMMINENT HAZARDS

I Sec 7. (a) Definition. — An imminent hazard .shall be considered to exist when
I the evidence is suflficient to show that a situation exists in which the continued
I use of a chemical substance would be likely to result in unreasonable adverse
) effects on the environment or will involve an unreasonable hazard to the sur-
vival of a species declaired endangered by the Secretary of the Interior under
Public Law 91-135.

(b) Actions Authorized.— The Administrator may file an action in a United
States district court —

(1) against an imminently hazardous chemical substance or mixture for
seizure of such substance or mixture,

(2) against any person who manufactureres. processes, distributes in
commerce, uses, or disposes of such substance or mixture, or

(3) against both (A) such substance or mixture and (B) such person.
An action under this subsection may be filed notwithstanding the existence of

1 a rule under section 4(a) or 6(a) or an order under section 5(e) and notwith-
I standing the pendency of any administrative or judicial proceeding under any
provision of this Act.

(c) Jfrisdiction of Court. — (1) The T'uited States district court in which
I an action under subsection (b) is brought shall have jurisdiction to grant such

temporary or permanent relief as may be nece.ssary to protect against such
unreansonable risk of death, serious illness or serious personal injury, or
serious environmental harm presented by the chemical substance or mixture
involved in such action.

(2) In the case of an action under subsection (b) brought against a person
who manufactures, processes, distributes in commerce, uses, or disposes of a
chemical substance or mixture, the relief authorized by paragraph (1) may
include the issuance of a mandatory order requiring (A) in the case of pur-
chasers of such substance or mixture known to the defendant, notification to
such purchasers of the ri.sk associated with it; (B) public notice of such risk:

280

(3) In the case of an action under subsection (b) against a chemical sub-
stance or mixture, such substance or mixture may be proceeded against by
process of libel for its seizure and condemnation. Proceedings in such an action
shall conform as nearly as possible to proceedings in rem in admiralty.

(d) Venue and Consolidation. — (1)(A) An action under subsection (b)
against a person who manufactures, processes, distributes in commerce, uses,
or disposes of a chemical substance or mixture may be brought in the United
States District Court for the District of Columbia or for any judicial district
in which any of the defendants is found, resides, or transacts business ; and
process in such an action may be served on a defendant in any district in which
such defendant resides or may be found. An action under subsection (b) against
a chemical substance or mixture may be brought in any United States district
court within the jurisdiction of which the substance or mixture is found.

(B) In determining the judicial district in which an action may be brought
under subsection (b) in instances in which such action may be brought in more
than one judicial district, the Administrator shall take into account the con-
venience of the parties.

(C) Subpoenas requiring attendance of witnesses in an action brought under
subsection (b) may run into any judicial district.

(2) Whenever proceedings under subsection (b) involving the same type of
chemical substances or mixtures are pending in courts in two or more judicial
districts, they shall be consolidated for trial by order of any such court upon
application reasonably made by any party in interest, upon notice to all parties
in interest.

(e) Action Under Section 6. — Where appropriate, concurrently with the
filing of an action under subsection (b) or as soon thereafter as may be practi-
cable, the Administrator shall initiate a proceeding for the promulgation of a
rule under section 6(a).

(f) Representation. — Notmthstanding any other provision of law, in any
action under subsection (b), the Administrator may direct attorneys of the En-
vironmental Protection Agency to appear and represent the Administrator in
such an action.

reporting and retention of information

Sec. 8. (a) Reports. — (1) The Administrator shall promulgate rules under
which —

(A) each person who maanufactures or processes or proposes to manu-
facture or process a chemical substance shall maintain such records, and
shall submit to the Administrator such reports, as the Administrator may
reasonably require, and

(B) each person who manufactures or processes or proposes to manu-
facture or process —

(i) a mixture, or

(ii) a chemical substance in small quantities (as defined by the Ad-
ministrator by rule) solely for scientific experimentation or analysis
or for chemical research or analy.sis. including such research or analysis
for the development of a product, shall maintain records and submit to
the Administrator reports but only to the extent the Administrator
determines the maintenance of records or submission of reports, or both,
is necessary for the effective enforcement of the Act. For purposes of
the compilation of the list of chemical substances required under sub-
section (b), the Administrator shall promulgate rules pursuant to this
subsection not later than 180 days after the date of the enactment of
this Act.

(2) The Administrator may require under paragraph (1) reporting with
respect to the following :

(A) The common name, trade name, the chemical identity, and the molecular
structure and identity of each chemical ."substance or mixture for which such a
report is required, insofar as known to the person making the report or insofar
as reasonably ascertainable.

(B) The categories or proposed categories of use of each such substance or
mixture, insofar as known to the person making the report or insofar as reason-
ably ascertainable.

(C) Reas^onable estimates of the amount of each substance and mixture to be
manufactured or processed and. insofar as known to the per.son making the

281

report or insofar as reasonably ascertainable, a reasonable estimate of the
amount of each such substance and mixture to be manufactured or processed
for each of its categories or proposed categories of use.

( D ) A description of the byproducts resulting from the manufacture, process-
ing, use, or disposal of each such substance or mixture, insofar as known to the
person making the report or insofar as reasonably ascertainable.

(E) All existing data concerning the environmental and health effects of such
substance or mixture, insofar as known to the person making the report or are
reasonably ascertainable.

( F) Estimates of the number of persons who will be exi)osed to such substance
or mixture in their places of employment and the duration of such exposure,
insofar as known to the person making the report or are reasonably
ascertainable.

(b) Inventory. — The Administrator shall compile, keep current, and publish
a list of each chemical substance or mixture which any person reports under
subsection (a) or under section 5(a) is manufactured or processed in the United
States. The Administrator shall first publish such a list not later than 270 days
after the date of enactment of this Act. The Administrator shall not include
in such list any chemical substance which is manufactured or processed only in
small quantities (as defined by the Administrator by rule) solely for scientific
experimentation or analysis or for chemical research or analysis, including such
research or analysis for the development of a product.

(c) Records. — Any person who manufactures, processes, or distributes in com-
merce or intends to manufacture, process, or distribute in commerce any chemical
substance or mixture shall maintain records of adverse reactions to health or the
environment alleged to have been caused by the substance or mixture. Recoi*ds
of such adverse reactions to the health of employees shall be retained for 30
years from the date such reactions were first reported to or known by the
person maintaining such records; and any other record of such adverse reactions
shall be retained for 5 years from the date the information contained in the
records was first reported to or known by the person maintaining the records.
Records under this subsection shall include records of consumer allegations
of personal injury or harm to health, reports of occupational disease or injury,
arid reports or complaints of injury to the environment submitted to the manu-
facturer, processor, or distributor in commerce from any source. Upon request of
an officer or employee duly designated by the Administrator, each person who is
required to maintain records under this subsection shall permit the inspection
of such records and shall submit copies of such records.

(d) Health axd Safety Studies. — The Administrator shall promulgate rules
under which the Administrator requires any person who manufactures, processes,
or distributes in commerce or who proposes to manufacture, process, or distribute
in commerce any chemical substance or mixture to submit to the Administrator —

(1) lists of health and safety studies conducted or initiated by or for such
person with respect to such substance or mixture at any time or known
to such rx'rson or are reasonably ascertainable, except that the Administra-
tor may exclude certain types or categories of studies from the require-
ments of this subsection if he finds that submission of lists of such studies
are unneces.sary. to carry out the purposes of this Act; and

(2) the Administrator may require the submission of any study contained
on a list otherwise known by such person.

(e) Notice to Administrator of T'nreasonable Risks. — Any i)erson who
manufactures, processes, or distributes in commerce a chemical substance or
mixture, and any liability insurer of such person, who obtains information which
supports the conclusion that such su])stance or mixture causes or contributes
to an unreasonable risk of injury to health or the environment shall imme-
diately inform the Administrator of such risk unless such person has reason
to believe that the Administrator has been adequately informed of such risk.

relationship to other federal laws

Sec. 0 (a) Lam's Not Administered by the Administrator. — (1) If the
Administrator has reason to believe that the manufacture, processing, distribu-
tion in commerce, use. or disposal of a chemical substance or mixture causes or
contributes to. or is likely to cause or contribute to an unreasonable risk
of injury to health or the environment, and determines, in his discretion, that
such risk may be prevented or reduced to a sufficient extent by action taken under

79-313 0 - 77 - 19

282

a Federal law not administered by the Administrator, the Administrator shall
request the agency which administers such law (A) to issue an order declar-
ing whether or not the manufacture, processing, distribution in commerce, use,
or disposal of such substance or mixture causes or contributes to or is likely
to cause or contribute to such a risk, and (B) if the agency issues an order
declaring that such manufacture, processing, distribution in commerce, use,
or disposal respecting such substance or mixture causes or contributes to or
is likely to cause or contribute to such a risk, to determine if such risk miay
be prevented or reduced to a sufficient extent by action taken under such law.
Any such request shall be published in the Federal Register and shall be
accompanied by a detailed statement of the information on which it is based.
The agency receiving the request shall consider carefully all data submitted
by the Administrator and other information available to it and shall issue
an appropriate order upon request, and shall make any resulting determination
within such reasonable time as the Administrator specifies in the request, but
such time specified may not be less than 90 days from the date the request was
made. The report of an agency in response to a request made under this i>ara-
graph shall be accompanied by a detailed statement of the findings and con-
clusions of the agency respecting the order and determination requested to be
made.

(2) If the Administrator makes a request under paragraph (1) with respect
to a chemical substance or mixture and the agency to which such request was
made either —

(A) issues an order declaring that there is no unreasonable risk of injury
to health or the environment associated with such substance or mixture, or

(B) initiates, within 90 days of the publication in the Federal Register of
the report of the agency under paragraph (1) in response to such request,
action under the law (or laws) administered by such agency to protect
against such a risk,

the Administrator may not take any action under section 6 or 7 with respect
to the risk associated with such substance or mixture. Nothing contained herein
shall prevent the Administrator from (A) making any subsequent request under
paragraph (1) with respect to such risks or (B) to take subsequent action under
this Act with respect to such risks if the requirements of this ^bsection are
satisfied.

(3) If the Administrator has initiated laction under section 6 or 7 with
respect to a risk of injury associated with a chemical substance or mixture
which was the subject of a request made to an agency under paragraph (1), such
agency shall before taking action under the law (or laws) administered by
it to protect against such risk consult with the Administrator for the pmpose of
avoiding duplication of Federal action against such risk.

(b) Laws Administered by the Administrator. — The Administrator shall
coordinate actions taken under this Act with actions taken under other Federal
laws administered in whole or in part by the Administrator. The Administrator
shall use the authorities contained in such other Federal laws to protect against
any risk to health or the environment associated with a chemical substance or
mixture unless the Administrator, in his discretion, determines that such risk
may be more appropriately protected ac-ainst under this Act. This subsection
shall not be construed to relieve the Administrator of any requirement imposed
on the Administrator by such other Federal laws. Nothing contained in this
subsection shall (1) aifect any final action taken under such other Federal law,
or (2) in any way affect the extent to which human health or the environment
is to be< protected under such other Federal law.

(c) OccTTPATioNAL SAFETY AND HEALTH. — In cxcrcisiug any authority under
this Act. the Administrator shall not, for purposes of section 4(b) (1) of the
Occupational Safety and Henlth Act of 1970. be deemed to be exercising statutory
authority to prescribe or enforce standards or regulations affecting occupational
safety and health.

(d) Coordination. — In administering this Act. the Administrator shall con-
sult and coordinate with the Secretarv of Health. Education, and Welfare and
the heads of any other appropriate Federal executive department or agency,
any relevant independent regulatory agency, and any other appropriate intsru-
mentalitv of the Federal Oovernment for the purpose of achieving the maxi-
mum enforcement of this Act while imposing the least burdens of duplicative
requirements on those subjects to the Act and for other purposes. The adminis-

283

I trator shall report annually to the Congre^ on actions taken to coordinate with
I such other Federal departments, agencies, or instrumentalities, and on actions

taken to coordinate the authority under this Act with the authority granted

under other Acts referred to in su])section (b).

(e) Exception. — Nothing contained in this section shall limit any require-
I ment of section 4, 5 (other than section 5(e)(2)), or 8, or rules promulgated

thereunder.

RESEARCH. COLLECTION. DISSEMINATION, AND UTILIZATION OF DATA

Sec. 10. (a) Authority. — The Administrators shall, in consultation and co-
operation with the Secretary of Health, p:ducation. and Welfare and with other
heads of appropriate agencies, conduct such research and monitoring as is
necessary to carry out the purposes of this Act. In accordance with such
respon.^ihilities. the Administrator shall undertake and support programs of re-
search and monitoring of iM)lychlorinated biphenyls to the extent neces.sary to
develop safe methods of disiK)sal of polychlorinated l)iphenyls and for the con-
trol of risks of injury to health or the environment associated with polychlo-
rinated biphenyls.

(b) Data Systems. — 0 ) The Administrator shall establish, administer, and be
responsible for the continuing activities of an interagency committee which will
(A) design, establish, and coordinate an efficient and effective sy.stem, within the
Environmental I'rotection Agency, for the collection, dissemination to other
Federal agencies, and u.<<e of data submitted to the Administrator under this Act
and (B) coordinate the regulation of chemical substances among Federal
agencies.

(2) (A) The Administrator shall, in consultation with the Secretary of Health,
Education, and Welfare and other heads of appropriate agencies, design, estab-
lish, and coordinate an efficient and effective system for the retrieval of toxi-
cological and other .scientific data which could be useful to the Administrator in
carrying out the purposes of this Act. Systematized retrieval shall be developed
for u.se by all Federal and other agencies with responsibilities in the area of
regulation or study of chemical substances and mixtures and their effect on
health, or the environment.

(c) Grants and Contracts. — The Administrator, in consultation with the
Secretary of Health. Education, and Welfare, is authorized to make grants and
enter into contracts in order to carry out his responsibilities under this section.
Contracts may be entered into under this section without regard to sections 3648
and 3709 of the Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5).

INSPECTIONS AND SUBPOENAS

Sec. 11. (a) Inspections. — (1) For puri>oses of administering this Act (in-
cluding any rule or order promulgated under this Act) the Administrator, or any
representative of the Administrator duly designated by the Administrator, may
insi^ect any establishment, facility, or other premises in which chemical sub-
stances or mixtures are manufactured, proce.ssed. stored, or held before or after
distribution in commerce and any conveyance l>eing u.^ed to transport chemical
substances or mixtures in connection with distribution in commerce. Such an
in.spection may only be made uimui presenting appropriate credentials and a writ-
ten notice to the owner, operator, or agent in charge of the premi.ses or convey-
ance to be inspected. A separate notice shall be given for each such inspection,
but a notice shall not l)e required for each entry made during the period covered
by the inspection. Each such inspection shall be commenced and completed with
reasonable promptness and shall be conducted at reasonable times, within rea-
sonable limits, and in a reasonable manner.

(2) An inspection under paragraph (1) shall extend to all things within the
premises or conveyance insi>ected (including records, files, papers, processes, con-
troLs. and facilities) bearing on whether the requirements of this Act applica-
ble to the chemical sul)stances or mixtures within such premises or conveyance
have been complied with.

(b) Subpoenas. — In carrying out his or her duties under the provisions of this
Act, the Administrator may by subpoena require the attendance and testimony of
witnesses and the production of reports, papers, documents, answers to questions,
or other information that the Administrator deems advisable. Witnesses shall
be paid the same fees and mileage that are paid witnes.ses in the courts of the

284

United ' states. In the event of contumacy, failure, or refusal of any person to
obey any such order, any district court of the United States in which venue is
proper shall have jurisdicion to order any such person to comply therewith. The
failure to obey such order of the Court is punishable by the Court as a contempt
thereof.

EXPORT

Sec. 12. (a) General. — (1) Except as provided in paragraph (2) and subsec-
tion (b), this Act (other than section 8) shall not apply to any chemical sub-
stance or mixture, if —

(A) it can be shown that such substance or mixture is being manufactured,
processed, sold, or held for sale, for export from the United States, unless
such substances or mixture is, in fact, manufactured, processed, or distrib-
uted in commerce, for use in the United States, and

(B) such substance or mixture, when distributed in commerce, or any
container in which it is enclosed when so distributed, bears a stamp or label
stating that such substance or mixture, is intended for export.

(2) Paragraph (1) shall not apply to any chemical substance or mixture if the
Administrator finds that the substance or mixture will cause or contribute to
an unreasonable risk of injury to the health of persons within the United States
or to the environment of the United States or may cause or contribute to such
risk. The Administrator may require, under section 4, testing of a chemical
substance or mixture exempted from this Act by paragraph (1) to determine
whether or not such substance or mixture causes or contributes to an unreason-
able risk to health within the United States or to the environment of the United
States.

(b) Notice. — (1) If any person exports or intends to export to a foreign
country a chemical substance or mixture for which the submission of data is
required under section 4 or 5, such person shall notify the Administrator of
such exportation or intent to export and the Administrator shall furnish to the
government of such country notice of the availability of the data (subject to
section 14) submitted to the Administrator under section 4 or 5 for such sub-
stance or mixture.

(2) If any person exports or intends to export to a foreign country a chemical
substance or mixture for which a rule has been proposed or promijlgated under
section 5 or 6, or with respect to which an action is pending, or relief has been
granted, under section 7, such person shall notify the Administrator of such
exportation or intent to export and the Administrator shall furnish to the gov-
ernment of such country notice of such rule, action, or relief.

ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES

Sec. 13. (a) General. — (1) The Secretary of the Treasury shall refuse entry
into the customs territory of the United States (as defined in general headnote 2
of the Tariff Schedules of the United States) of any chemical substance or mix-
ture offered for entry if —

(A) it fails to conform with any requirement of this Act or any rule in
effect thereunder, or

(B) it is otherwise prohibited pursuant to this Act from being distributed
in commerce.

(2) If a chemical substance or mixture is refused entry under paragraph (1),
the Secretary of the Treasury shall notify the consignee of such entry refusal,
shall not release it to the consignee, and shall cause its disposal or storage (under
such regulations as the Secretary of the Treasury may prescribe) if it has not
been exported by the consignee within 90 days from the date of receipt of notice
of such refusal, except that the Secretary of the Treasury may, pending a review
by the Administrator of the entry refusal, release to the consignee such sub-
stance or mixture on execution of bond for the amount of the full invoice of
such substance or mixture (as such value is set forth in the customs entry),
together with the duty thereon. On failure to return such substance or mixture
for any cause to the custody of the Secretary of the Treasury when demanded,
such consignee shall be liable to the United States for liquidated damages equal
to the full amount of such bond. All charges for storage, cartage, and labor on
such substances or mixtures which are refused entry or release under this sec-
tion shall be paid by the owner or consignee, and in default of such payment
shall constitute a lien against any future entry made by such owner or con-

285

signee. Nothing contained herein shall limit any other remedy to which the United
States is entitled.

(b) Rules. — The Secretary of the Treasury, after consultation with the
Administrator, shall issue rules for the enforcement of subsection (a) of this
section.

DISCLOSURE OF DATA

Sec. 14. Any information reported to, or otherwise obtained by, the Adminis-
trator or his representatives, under this Act, shall be subject to section 552 of
title 5, United States Code; except that such information shall be disclosed —

(1) upon request, to officers or employees of the United States, in connec-
tion with their official duties (A) under laws protecting human health or the
environment or (B) for specific law enforc-ement purposes;

(2) to contractors with the United States and employees of such con-
tractors if in the opinion of the Administrator such disclosure is necessary
for the satisfactory performance by the contractor of a contract with the
United States entered into on or after the date of enactment of this Act for
the performance of work in connection with this Act and under such condi-
tions as the Administrator may specify ;

(3) whenever the Administrator determines it necessary to protect human
health or the environment ; or

(4) to any duly authorized committee of the Congress upon written re-
quest of such commitee or any chairman thereof.

PROHIBITED ACTS

Sec. 15. It shall be unlawful for any person to —

(1) fail or refuse to comply with (A) any rule or order promulgated under
section 4, (B) any requirement prescribed by section 5 or 6, or (C) any rule
or order promulgated under section 5 or 6 ;

(2) use or dispose of a chemical substance or mixture which such person
knew or had reason to know was manufactured, processed, or distributed
in commerce in violation of section 5 or a rule or order under section 6 ;

(3) fail or refuse to (A) establishor maintain records, (B) submit reports,
notices, or other information, or (C) permit access to or copying of records, as
required by this Act or a rule thereunder; or

(4) fail or refuse to permit entry or inspection as required by section 11.

PENALTIES

Sec. 10. (a) Civil. — (1) Any person who violates a provision of section 15 of
this Act shall be liable to the United States for a civil penalty in an amount not
to exceed $25,000 for each such violation. Each day such a violation continues
shall for purposes of this subsection constitute a separate violation of section 15.

(2) (A) A civil i>enalty for a violation of section 15 shall l)e assessed by the
Administrator by an order made on the record after opi>ortunity (provided in
accordance with this subparagraph) for a hearing in accordance with section 554
of title 5, United States Code. Before issuing such an order, the Administrator
shall give written notice to the person to be assessed a civil penalty under such
order of the Administrator's proposal to issue such order and providing such
person an opportunity to re<iuest, within 15 days of the date the notice is received
by such person, such a hearing on the order.

(B) In determining the amount of a civil penalty, the Administrator shall take
into account the nature, circumstances, extent, and gravity of the violation or
violations and, with respect to the violator, ability to pay, effect on ability to con-
tinue to do business, any history of prior such violations, the degree of culpa-
bility, and such other matters as justice may require.

(C) The Administrator may compromise, modify, or remit, with or without
conditions, any civil penalty which may be imposed under this subsection. The
amount of such penalty, when finally determined, or the amount agreed upon in
compromise, may be deducted from any sums owed by the United States to the
person charged.

(3) Any person who requested in accordance with paragraph (2) (A) a hearing
respecting the assessment of a civil penalty and who is aggrieved by an order
assessing a civil penalty may file a petition for judicial review of such order
with the United States Court of Appeals for the District of Columbia Circuit or
for any other circuit in which such person resides or transacts business. Such a

286

petition may only be filed within the 30-day period beginning on the date the
order making such assessment was issued.

(4) If any person fails to pay an assessment of a civil i)enalty after it has
become a final and unappealable order, or after a court in an action brought
under paragraph (3) has entered final judgment in favor of the Administrator,
the Attorney General shall recover the amount assessed (plus interest at cur-
rently prevailing rates from such date) in any appropriate United States district
court. In such action, the validity, amount, and appropriateness of such penalty
shall not be subject to review.

(b) Criminal.— (1) Any person who knowingly or willfully violates any
provision of section 15 shall, in addition to or in lieu of a civil penalty which may
be imposed under subsection (a) of this section for such violation, be subject
upon conviction, to a fine of not more than $25,000 for each day of violation, or
to imprisonment for not more than 1 year, or both.

(2) For purposes of paragraph (1), the term "knowingly" means having actual
knowledge.

SPECIAL ENFORCEMENT AND SEIZURE

Sec. 17. (a) Specific Enforcement. — (1) Upon application of the Adminis-
trator or the Attorney General the United States district courts shall have juris-
diction over civil actions to —

(A) restrain any violation of section 15,

(B) restraint any person from manufacturing or processing a chemical
substance before the expiration of the period during which such manufac-
turing or processing is i>rohibited under section 5,

(C) restrain any person from taking any action prohibited by a require-
ment prescribed under section 5 or 6 or rules or orders issued thereunder or,

(D) direct any manufacturer or a chemical substance or mixture not in
compliance with any order issued under section 5(e) or any rule issued under
section 4 or 6, (i) to give notice of such fact to distributors in commerce of
such substance or mixture and, to the extent reasonably ascertainable, to
other persons in possession of such substance or mixture or exposed to such
substance or mixture, (ii) to give public notice of such risk of injury, and
(iii) to either replace or repurchase such substance or mixtu?fe whichever
the person to which the requirement is directed elects.

(E) compel the taking of any action required by or under this Act.
(2) A civil action described in paragraph (1) may be brought —

(A) in the case of a civil action described in subparagraph (A) of such
paragraph, in the United States district court for the judicial district wherein
any act, omission, or transaction constituting a violation of section 15 oc-
curred or wherein the defendant is found or transacts business, or

(B) in the case of any other civil action described in such paragraph, in
the United States district court for the judicial district wherein the de-
fendant is found or transacts business.

In any civil action process may be served on a defendant in any judicial district
in which a defendant resides or may be found. Subpoenas requiring attendance of
witnesses in any such action may run into any judicial district.

(b) Seizure. — Any chemical substance or mixture which was manufactured,
processed, or distributed in commerce in violation of this Act or any rule or order
promulgated under this Act shall be liable to be proceeded against, by process of
libel for the seizure and condemnation of such substance or mixture in any United
States district court within the jurisdiction of which such substance or mixture
is found. Such proceedings shall conform as nearly as possible to proceedings in
rem in admiralty.

pre-emption

Sec. 18. (a) Effect on State Law. — (1) Except as provided in paragraph (2),
nothing in this Act shall affect the authority of any State or political subdivision
of a State to establish or continue in effect regulation of any chemical substance
or mixture containing a chemical substance or mixture.
(2) Except as provided in subsection (b) —

(A) if the Administrator requires by rule promulgated under section 4 the
testing of a chemical substance or mixture, no State or political subdivision
may, after the effective date of such rule, require the testing of such substance

287

or mixture for purposes similar to those for which testing is required under

^"(6^!? 'the'^\dministrator prescribes a requirement under section 5 or 6
of this let whlch^s applicable to a chemical substance or mixture and which
's de gted^o protect against a risk to health or the envm>nment associated
with such substance or mixture no State or political subdivision of a State
may after me eff^tive date of such requirement, establish or contmue in
effect a requirement applicable to such substance or mixture and designed to
protect aXst such risk unless such requirement is identical to tbe require-
ment prescribed by the Administrator or unless such State or political sub-
div?sioirrequi?ement prohibits the use or distribution of such substance or
mixture w?thin the territorial jurisdiction of the State or pohtical sub-

(b? ExEMPTioN.-Upon application of a State or political subdivision of a
State, the Administrator may by rule exempt such State or subdivision from
subse<>tion (a) (2), under such conditions as may be prescribed in such rule, if—
"(1) compliance with the requirement would not cause the substance or
mixture to be in violation of the applicable under this Act described in
subsection (a) (2), and . c-^ifi

C^) the State or pohtical subdivision requirement (A) provides a signifi-
cantly higher degree of protection from such risk than the requirement under
this Act described in subsection (a) (2), and (B) does not, through difficul-
ties in marketing, distribution, or other factors, unduly burden interstate
commerce.

JUDICIAL REVIEW

Sec. 19. (a) General.— Not later than GO days following the promulgation of
any rule under this Act or an order under section 5(e), any interested person may
file a i)etition for judicial review of such rule or order with the United States
Court of Appeals for the District of Columbia Circuit, or for the circuit in which
such person resides or in wliich such i)erson's principal place of business is
located. Copies of the i>etition shall be forthwith transmitted by the clerk of
such court to the Administrator and to the Attorney General. The Administrator
shall transmit to the Attorney General, wlio shall tile in the court, the record
of the proceedings on which the Administrator based such rule or order as
provided in section 2112 of title 28, United States Code. For purposes of this
section, the term "record" means such rule or order, any transcript required of
any oral presentation ; any written submission of interested parties ; and any
other information which the Administrator, (m or before the date of the promul-
gation of such rule or order, published a notice in the Federal Register identify-
ing such information.

(b) Additional Data. — If the petitioner applies to the court for leave to
adduce additional data, views, or arguments, and shows to the satisfaction of
the court that such additional data, views, or arguments are material and that
there are reasonable grounds for the i)etitioner\s failure to adduce such data,
views, or arguments in the proceeding before the Administrator, the court may
order the Administrator to provide additional opportunity for oral presentation
of data, views, or arguments and for written submissions. The Administrator
may modify findings or determinations upon which the rule or order, subject to
review by such court was based, or make new findings or determinations by rea-
son of the additional data, views, or arguments so taken and shall file such
modified or new findings or determinations, and the Administrator's recommenda-
tion, if any, for the modification or setting aside of such rule or order, with the
return of such additional data, views, or arguments.

(c) Authority and Review Standard. — (1) Upon the filing of a petition under
subsection (a), the court shall have jurisdiction (A) to review the rule or order
involved in accordance with chapter 7 of title 5, United States Code, and (B)
to grant appropriate relief, including interim relief, as provided in such chapter,
except that any rule promulgated by the Administrator under section 3(b), 5,
or 6 of this Act and reviewed under this section shall be affirmed, unless the rule
is not supported by substantial evidence on the record taken as a whole.

(2) The judgment of the court affirming or setting aside, in whole or in part,
any rule or order reviewed in accordance with this section shall be final, subject to
review by the Supreme Court of the United States upon certiorari or certification,
as provided in section 12'54 of title 28, the United States Code.

288

(3) The judgment of the court in an action brought pursuant to subsection (a)
mav include an award of costs of suit and reasonable fees for attorneys and ex-
pert witnesses if the court determines that such an award is appropriate. The bu-
preme Court of the United States in its decision on a review of a judgment in
such an action mav provide for the award of costs in suit and reasonable fees for
attornevs if the court determines that such an award is appropriate.

(d) Other Remedies.— The remedies provided in this section shall be in addi-
tion to and not in lieu of any other remedies provided by law.

citizen's civil action

Sec. 20. (a) In General.— Except as provided in subsection (b), any person
may commence a civil action —

(1) against any person (including (A) the United States, and (B) any
other governmental instrumentality or agency to the extent permitted by
the eleventh amendment to the Constitution) who is alleged to be in violation
of this Act or any rule or order prescribed under section 4, 5, or 6(a) to re-
strain such violation, or

(2) against the Administrator to compel the Administrator to perform any
act or duty under this Act which is not discretionary.

Any civil action under i>aragraph (1) shall be brought in the district court of
the' United States for the district in which the alleged violation occurred or in
which the defendant resides or in which the defendant's principal place of busi-
ness is located. Any action brought under paragraph (2) shall be brought in the
district court for the District of Columbia, or the United States district court for
the judicial district in which the plainiff is domiciled. The district courts shall
have jurisdiction over suits brought under this section, without regard to the
amount in controversy or the citizenship of the parties. In any civil action under
this subsection, process may be served on a defendant in any judicial district in
which the defendant resides or may be found and subpoenas for witnesses may
run into any judicial district.

(b) Limitation. — No civil action may be commenced —

(1) under subsection (a)(1) to restrain a violation of this Act or rule or
order under this Act —

(A) before the expiration of sixty days after the plaintiff has given
notice of such violation (i) to the Administrator, and (ii) to the person
who is alleged to have committed such violation, or

(B) if the Administrator (or Attorney General on his behalf) has
commenced and is diligently prosecuting a civil action in a court of the
United States to require compliance with this Act of such rule, but if
such action is commenced after the giving of notice, any person giving
such notice may intervene as a matter of right in such action ; or

(2) under subsection (a)(2) before the expiration of 60 days after the
plaintiff has given notice to the Administrator of the alleged failure of the
Administrator to perform an act or duty which is the basis for such action
or, in the case of an action under such subsection for the failure of the Ad-
ministrator to file an action under section 7, before the expiration of 10 days
after such notification.

Notice under this subsection shall be given in such manner as the Administrator
shall prescribe by rule.

(c) General. — (1) In any action under this section, the Administrator, if not
a party, may interv ene as a matter of right.

(2) The court, in issuing any final order in any action brought pursuant to
subsection (a), may award costs of suit and reasonable fees for attorneys and
expert witnesses if the court determines that such an award is appropriate.
Any court, in issuing its decision in an action brought to review such an order,
may award costs of suit and reasonable fees for attorneys if the court deter-
mines that such an award is appropriate.

(3) Nothing in this section shall restrict any right which any person (or
class of persons) may have under any statute or common law to seek enforce-
ment of this Act or any rule under this Act or to seek any other relief.

(d) Consolidation. — When two or more civil actions brought under subsec-
tion (a) involving the same defendant or plaintiffs and the same issues or viola-
tions are pending in two or more judicial districts, such pending actions, upon

289

application of such defendant or plaintiff to such actions which is made to a
court in its discretion so decides, be consolidated for trial by order (issued
after giving all parties reasonable notice and opportunity to be heard) of such
court and tried in —

(1) any district which is selected by such defendant or plaintiff and in
which one of such actions is pending.

(2) a district which is agreed upon by stipulation between all the parties
to such actions and in which one of such actions is pending, or

(3) a district which is selected by the court and in which one of such
actions is pending.

The court issuing such an order shall give prompt notification of the order to
the other courts in which the civil actions consolidated under the order are
pending.

citizens' petitions

Sec. 21. (a) Ix General. — Any person may petition the Administrator to
issue a rule or order, or to take other action under this Act, the purpose of
which is to protect against an unreasonable risk of injury to health or the
environment.

(b) Procedures. — (1) Such petition shall be filed in the principal office of
the Administrator and shall set forth the facts which it is claimed establish
that such rule, order or other action is necessary.

(2) The Administrator may hold a public hearing or may conduct such
investigation or proceeding as the Administrator deems appropriate in order to
determine whether or not such petition should be granted.

(3) Within 90 days after filing of a petition described in paragraph (1), the
Administrator shall either grant or deny the petition. If the Administrator
grants such petition, the Administrator shall promptly commence an appropriate
proceeding to comply with such petition. If the Administrator denies such
petition, the Administrator shall publish in the Federal Register the Adminis-
trator's reasons for such denial.

(4) (A) If the Administrator denies a petition filed under this section (or if
the Administrator fails to grant or deny such petition within the 90-day period),
the petitioner may commence a civil action in a United States district court to
compel the Administrator to initiate the action requested. Any such action shall
be filed within 60 days after the Administrator's denial of the petition or, if
the Administrator fails to grant or deny the petition within 90 days after filing
the petition, within GO days after the expiration of the 90-day period.

(B) If the petitioner can demonstrate to the satisfaction of the court, by a
preponderance of the evidence in a de novo proceeding before such court, that
the action requested in the petition conforms to the applicable requirements
of this Act, the court shall order the Administrator to initiate the action requested
by the petitioner.

(C) The court in issuing any final order in any action brought pursuant to
subparagraph (A), may award costs of suit and reasonable fees for attorneys
and expert witnesses if the court determines that such an award is appropriate.
Any court, in issuing its decision in an action brought to review such an order,
may award costs of suit and reasonable fees for attorneys if the court deter-
mines that such an award is appropriate.

(5) The remedies under this section shall be in addition to, and not in lieu
of, other remedies provided by law.

NATIONAL DEFENSE WAI\T:R

Sec. 22. The Administrator shall waive compliance with any provision of this
Act upon request of the Secretary of Defense and upon a determination by the
President that the requested waiver is necessary in the interest of national
defense. The Administrator shall maintain a written record of the basis upon
which such waiver was granted and make such record available for in camera
examination when relevant in a judicial proceeding under this Act. Upon the
issuance of such a waiver, the Administrator shall publish in the Federal
Register a notice that the waiver was granted for national defense purposes,
unless, upon the request of the Secretary of Defense, the Administrator deter-
mines to omit such publication because the publication itself would be contrary
to the interests of national defense, in which event the Administrator shall
submit notice thereof to the Armed Services Committees of the Senate and the
House of Representatives.

290

EMPLOYEE PROTECTION

Sec. 23. (a) General. — No employer may discharge any employee or otherwise
discriminate against any employee with respect to the employee's compensation,
terms, conditions, or privileges of employment because the employee (or any
person acting pursuant to a request of the employee) has —

( 1 ) commenced, caused to be commenced, or is about to commence or cause
to be commenced a proceeding under this Act;

(2) testified or is about to testify in any such proceeding; or

(3) assisted or participated or is about to assist or participate in any
manner in such a proceeding or in any other action to carry out the puri)oses
of this Act.

(b) Remedy. — (1) Any employee who believes that he or she has been dis-
charged or otherwise discriminated against by any person in violation of sub-
section (a) of this section may, within 30 days after such alleged violation
occurs, file (or have any person file on the employee's behalf) a complaint with
the Secretary of Labor (hereinafter in this section referred to as the "Secre-
tary") alleging such discharge or discrimination. Upon receipt of such a com-
plaint, the Secretary shall notify the person named in the complaint of the
filing of the complaint.

(2) (A) Upon receipt of a complaint filed under paragraph (1), the Secretary
shall conduct an investigation of the violation alleged in the complaint. Within
30 days of the receipt of such complaint, the Secretary shall complete such
investigation and shall notify in writing the complainant (and any i)erson
acting on behalf of the complainant) and the person alleged to have committed
such violation of the results of the investigation conducted pursuant to this
paragraph. Within 90 days of the receipt of such complaint the Secretary shall,
unless the proceeding on the complaint is terminated by the Secretary on the
basis of a settlement entered into by the Secretary and the person alleged to
have committed such violation, issue an order either providing the relief pre-
scribed by subparagraph (B) or denying the complaint. An order of the Secretary
shall be made on the record after notice and opportunity for agency hearing.
The Secretary may not enter into a settlement terminating a proceeding on a
complaint without the participation and consent of the complaimint.

(B) If in response to a complaint filed under paragraph (1) the Secretary
determines that a violation of subsection (a) of this section has occurred, the
Secretary shall order (i) the person who committed such violation to take
affirmative action to abate the violation, (ii) such person to reinstate the com-
plainant to the complainant's former position together with the comi)ensation
(including back pay), terms, conditions, and privileges of the complainant's em-
ployment, (iii) comi)ensatory damages, and (iv) where appropriate, exemplary
damages. If such an order is issued, the Secretary, at the request of the com-
plainant shall assess against the person against whom the order is issued a
sum equal to the aggregate amount of all costs and expenses (including attorney's
fees ) reasonably incurred, as determined by the Secretary, by the complainant
for, or in connection with, the bringing of the complaint upon which the order
was issued.

(c) REv^EW. — (1) Any person adversely affected or aggrieved by an order
issued under subsection (b) may obtain review of the order in the United States
Court of Appeals for the circuit in which the violation, with respect to which
the order was issued, allegedly occurred. The petition for review must be filed
within 60 days from the issuance of the Secretary's order. Review shall conform
to chapter 7 of title 5 of the United States Code.

(2) An order of the Secretary, with resx)ect to which review could have been
obtained under paragraph (1), shall not be subject to judicial review in any
criminal or other civil proceeding.

(d) Enforcement. — (1) Whenever a person has failed to comply with an
order issued under subsection (b)(2), the Secretary shall file a civil action
in the United States district court for the district in which the violation was
found to occur to enforce such order. In actions brought under this subsection,
the district courts shall have jurisdiction to grant all appropriate relief, includ-
ing injunctive relief and compensatory and exemplary damages. Civil actions
brought under this subsection shall be heard and decided expeditiously.

(2) Any nondiscretionary duty imposed by this section is enforceable in a
mandamus proceeding brought under section 1361 of title 28, United States
Code.

291

(e) Exclusion. — Subsection (a) of this section shall not apply with respect
to any employee who, acting without direction from the employee's employer
(or any agent of the employer), deliberately causes a violation of any require-
ment of this Act.

(f) Employment Effects. — (1) The Administrator shall conduct continuing
evaluations of the potential loss or shifts of employment which may result from
the issuance of any rule or order under this Act, including, where appropriate,
investigating threatened plant closures or reductions in employment allegedly
resulting from such rule or order.

(2) Any employee who is discharged or whose employment is otherwise
interrupted, or is threatened with discharge or such interruption, or otherwise
discriminated against by any person because of the results of any rule or order
issued under this Act, or a representative of such employee, may request the
Administrator to conduct a full investigation of the matter. The Administrator
shall thereupon investigate tlie matter and. at the re(iuest of any interested party,
shall hold a public hearing on not less than 5 days notice, and shall at such
hearings require the parties, including the employer involved, to present infor-
mation relating to the actual or potential effect of such rule or order on employ-
ment and on any alleged discharge, interruption of employment, or other discrimi-
nation and the detailed reasons or justification therefor. Any such hearing shall
be of record and shall be conducted in accordance with section 554 of title 5,
United States Code.

(3) Upon receiving the report of any such investigation, the Administrator
shall make findings of fact as to the effect of such rule or order on employment
and the alleged discharge, interruption of employment, or discrimination and
shall make such recommendations as he deems appropriate. Such report, find-
ings, and recommendations shall be available to the public.

(4) Notliing in this subsection shall be construed to require the Administrator
to modify or withdraw any rule or order issued under this Act.

STUDIES

Sec. 24. (a) Indemnification. — The General Accounting OflSce shall conduct
a study of all Federal laws administered by the Administrator for the purpose
of determining whether and under what conditions, if any, indemnification
should be accorded any person as a result of any action taken by the Adminis-
trator under any such law. The study shall —

(1) include an estimate of the probable cost of any indemnification
programs which may be recommended ;

(2) include an examination of all viable means of financing the cost
of any recommended indemnification ; and

(3) be completed and submitted to Congress not less than 2 years from
the date of enactment of this Act.

(b) Classification. Storage, and Retrieval. — The Council on Environmental
Quality, in consultation with the Administrator, the Secretary of Health, Edu-
cation, and Welfare, the Secretary of Commerce, and the heads of other appro-
priate Federal departments or agencies, shall coordinate a study of the feasibil-
ity of establishing (1) a standard classification system for chemical substances
and related substances, and (2) a standard means for storing and for obtaining
rapid access to information respecting such substances. A report on such study
shall be completed and submitted to Congress not later than 18 months after
the date of the enactment of this Act.

state demonstration programs

Sec. 25. (a) Establishment of Program. — The Administrator is authorized
to assist no more than three states in establishing demonstration programs by
such States to protect against unreasonable risks to health or the environment
associated with chemical substances and mixtures. Such programs shall —

(A) identify and inventory chemical substances and mixtures within such
State, including their manufacture, processing, distribution, use, and
disposal ;

(B) monitor the extent to which such chemical substances or mixtures
are present in the environment of such State and the human exposure to
such substances or mixtures within such State;

to health or the environment presented by chemical substances or mixtures,
(ii) integrate the control of chemical substances and mixtures under this

292 I

section with other programs or environmental and public health protection
within such State so as to appropriately minimize the overall pollution of
the environment within such State; and (iii) identify the appropriate
governmental institutions and processes necessary to implement a program
for the prevention of unreasonable risks to health or the environment
presented by chemical substances and mixtures :

(D) analyze and evaluate the results of such programs through annual
reports to the Administrator ; and

(E) complement and in no way reduce Federal efforts under this Act
in such State.

{[)) Rkports. — The Administrator shall submit a report to the appropriate
commitees of Congress not later tlian July 1 of each calendar year. Such report
shall inchide (1) a description of progress with respect to programs as.'-isted
under this section and any suggestions for improvement in such program, (2)
recommendations as to the manner by which programs within the States for the
pre^■ention of unreasonable risk to health jr the environment presented by
chemical substances may feasibly be implemented, and (3) the extent to which
the Administrator has disseminated information regarding programs authorized
under this section to other interested States and other persons.

(c) Authorization fob Appropriations. — For the purposes of providing
assistance under this section, there are hereby authorized to be appropriated
not to exr^eed $2,0(K),00() for the fiscal year ending September 30, 1977 : $2,(K)O.()00
for the fiscal year ending September 30, 1978, and $2,000,000 for the fiscal year
ending on September 30, 19 « 9. Any funds appropriated under the authority of
this subsection shall remain available until exj^ended. Funds available under
this section shall not be available for programs which would duplicate any
authority or requirements of the Administrator under this Act, including sections
4, 5, 6, and 9(c). Funds available under the authority of this section shall sup-
port not more than 75 percent of the costs of any such program described under
subsection (a) engaged in by the State.

(d) Prioritees. — Assistance afforded under this section shall be available
(subject to the requirements of subsection (a)) to those States which can
establish a priority need for such assistance, as determined by ti)e rules of the
Administrator. In establishing such rules, the Administrator shall consider the
existence of serious health effects associated with chemical substances within
such State including cancer, birth defects, and gene mutations; the extent to
which chemical substances and mixtures are manufactured, processed, dis-
tributed in commerce, used and disposed of within such State ; and the extent
of exposure of human beings and the environment to chemical substances and
mixtures within such State. The Administrator shall approve all such programs
and estal)lish a mechanism for monitoring such programs.

(e) Disci^\iMER. — Nothing contained in this section shall affect any provision
of section 18 of this Act.

administration of act

Sec. 26. (a) Cooperation of Federal Agencies. — Upon request by the Admin-
istrator, each Federal department and agency is authorized —

(1) to make its services, personnel, and facilities available (with or with-
out reimbursement) to the Administrator to assist the Administrator in the
administration of this Act ; and

(2) to furnish to the Administrator such information, data, estimates, and
statistics, and to allow the Administrator access to all information in its
possession as the Administrator may reasonably determine to be necessary
for the administration of this Act.

(b) Fees. — The Administrator may, by rule, require the payment of a reason-
able fee from any person required to submit data under section 4 or 5 of this
Act to defray the costs of administering this Act. Such rules shall not provide
for any fee in excess of $2,500. In setting such a fee, the Administrator shall
take into account the ability to pay of the person required to submit the data
and the cost to the Administrator of reviewing such data. Such rules may pro-
vide for sharing such a fee in any case in which the expenses of testing are
shared under section 4 or 5 of this Act.

(c) Action With Respect to Categories. — (1) Any action which may be
taken by the Administrator under any i)rovision of this Act with respect to a
chemical substance or mixture may be taken by the Administrator in accordance
with that provision with respect to a category of chemical substances or mix-
tures. Whenever the Administrator takes action under a provision of this Act

293

with respect to a category of chemical substances or mixtures, any reference in
this Act to a chemical substance or mixture (insofar as it rr'lates to such action)
shall be deemed to be a reference to all chemical substances or mixtures in such
category.

(2) For purposes of paragraph (1) :

(A) The term "category of chemical substances" means a group of chem-
ical substances the members of which are similar in molecular structure,
in physical, chemical, or biological properties, in use, or in mode of entrance
into the human body or into the environment, or the members of which are
in some other way suitable for classification as such for purposes of this
Act, except that such term does not mean a group of chemical substances
which are grouped together solely on the basis of their being new chemical
substances.

(B) The term '"category of mixtures" means a group of mixtures the
members of which are similar in molecular structure, in physical, chemical,
or l)iological properties, in use, or in mode of entrance into the human
body or into the environment, or the members of which are in some other
way suitable for classification as such for purposes of this Act.

(d) Statement of Purpose and Justification. — Any proposed or final rule
or order issued under this Act shall be accompanied by a statement of purpose
and justification. Such a statement shall be considered part of the "record of
the proceedings" for purposes of judicial review under section 19(a).

(e) Assistant Administrator. — The I'resident, by and with the advice and
consent of the Senate, shall appoint an Assistant Administrator for Toxic
Substances of the Environmental Protection Agency. Such Assistant Adminis-
trator shall be a qualified individual who is, by reason of background and ex-
perience, especially qualified to direct a program concerning the effects of
chemicals on human health and the environment. Such As.sistant Administrator
shall be responsible for the collection of data, the preparation of studies, and
the making of recommendations to the Administrator for regulatory and other
actions to carry out the purposes, and to facilitate the administration of this
Act.

authorization for appropriations

Sec. 27. (a) In General. — There is authorized to be ap])ropriated to the Ad-
ministrator, for purposes of carrying out this Act, $11.(K)(>,000 for the fiscal year
ending June 30, 1976, $2.6(K).()()() for the period beginning July 1 1976 and ending
September 30, 1976, and $10,100,000 for the fiscal year ending September 30.
1977. No part of the funds so authorized to be appropriated shall be used to con-
struct any research laboratories.

(b) Budget Requests. — Whenever the Administrator directly or indirectly
submits in connection with this Act, any budget requests, supplemental budget
estimates, legislative recommendations, prepared testinnmy for congressional
hearings, or comments on legislation to the Pre.sident or to tiie Office of Manage-
ment and Budget, or persons acting on their behalf, the Administrator shall con-
currently transmit a copy thereof to the Congress. No oflficer or agency of the
United States shall have any authority to require the Administrator to submit
budget requests or estimates, legislative recommendations;, prepared testimony
for congressional hearings, or connnents on legislation relating to this Act to
any officer or agency of the I'nitod States for approval, comments, or review,
prior to the submis.sion of such requests, estimates, recommendations, testi-
mony, or comments to the Congress.

annual report

Sec. 28. The Administrator shall prepare and submit to the President and
the Congress on or before January 1 of each year a comprehensive report on
the administration of this Act during the preceding fiscal year. Such report
shall include —

(1) a list of the testing required under section 4 during the year for
which the report is made and an estimate of the costs Incurred during
such year by the persons required to perform such tests :

(2) the number of notices received during such year under section 5, the
number of such notices received during such year under such section for
chemical substances and mixtures subject to a section 4 rule, and a sum-
mary of any action taken during such year under section 5(e) ;

294

(3) a list of rules issued during such year under section 6 ;

(4) a list, with a brief statement of the issues, of completed or pending
judicial or enforcement actions under this Act during such year ;

(5) a summary of major problems encountered in the administration of
this Act ; and

(6) such recommendations for additional legislation as the Administrator
deems necessary to carry out the purposes of this Act.

Mr. Hartke subsequently said : Mr. President, in view of the large
vote by which the toxic substances bill was passed, I would like to
point out this matter has now been pending as a matter of request
from the administration since February of 1970, and we have worked
very closely with some ^lembers of the House of Representatives, and
I would hope that the House would give urgent consideration to com-
ing forward now with legislation which will not be stalemated as it
has been in the past.

There is not need for us to delay any longer the protection which
could be afforded to millions of Americans simply by the utilization
of the scientific method of telling the people what they need to know.
I think it is high time that w^e eliminate the scare tactics which fre-
quently are put forward about some item which may be dangerous to
the health or environment and, at the same time, prove at a later date
that it is not.

On the other hand, there are thousands and thousands of items
which, at this moment, still are going undetected and unknown by
millions of Americans and it is high time we recognized that they are
entitled not alone to the right to know but the right to have the
Administrator of the Environmental Protection Agency to move
effectively and immediately to do what he can to provide better health
and a cleaner environment for Americans.

Mr. Talmadge. Mr. President, if the distinguished Senator from
California and the distinguished Senator from Kansas will give me
their attention, there are two questions I desire to propound on this
bill.

I ask the distinguished floor manager of the bill : A^^lat effect would
this legislation have upon the small bulk blend fertilizer operator
who, in response to a farmer's request, changes the fertilizer mix ratio
and perhaps add a pesticide?

Mr. TuxxEY. It would have no effect if this mixture is« classified
as a pesticide under the pesticide law.

Mr. Talmadge. Does the Senator from Kansas share that view?

^Ir. Pearson. I share that view.

Mr. Talmadge. One further inquiry: \\Tiat sort of individual
recordkeeping and notification requirements would be made of this
small fertilizer operator?

Mr. TuxxEY. Xone, if the mixture is classified as a pesticide under
the i^esticide law.

Mr. Pearsox. The answer is in the negative, no.

Mr. Talmadge. Does the Senator from Kansas share that view?

Mr. Pearson. Yes.

Mr. Talmadge. I thank the Senators.

CHAPTER III

H.R. 14032 TOGETHER WITH EEPORT AND DEBATE

Note. — H.R. 14032 was the last of several versions of the Toxic Substances
Control Act introduced in the House ; early versions on which hearings were
held included H.R. 7229, H.R. 7548, and H.R. 76G4. and a later version reported
by the Subcommittee on Consumer Protection and Finance was H.R. 10318.

297

Union Calendar No. 694

~ H. R. 14032

[Report No. 94-1341]

IN THE HOUSE OF REPRESENTATIVES

IVIay 26, 1976

Mr. EcKHARDT (for himself, Mr. Broyhill, Mr. Murphy of New York, Mr.
Van Deerlin, Mr. Moss, Mr. Rooney, Mr. Scheuer, Mr. Carney, Mr.
MoFFETT, Mr. RiNAUX), and Mr. Lent) introduced the following bill;
which was referred to the Committee on Interstate and Foreign Commerce

July 14,1976

Reported with an amendment, committed to the Committee of the Whole House
on the State of the Union, and ordered to be printed

[Strike out all after the enacting clause and insert the part printed in italic]

A BILL

To regulate commerce and protect health and the environment
by requiring testing and necessary restrictions on certain
chemical substances and mixtures, and for other purposes.

1 Be it enacted by the Senate and House of Representa-

2 tives of the United States of America in Congress assembled.

18
19

SHORT TITLE

Section 1. This Act may he cited as the *'Toxk Sub-
stances Control Acf\

TABLE OF CONTENTS

Sec. 1. Short title.

Sec. 2. Findings^ policy^ and intent.

Sec. 3. Definitions.

Sec. Jh Testing of chemical aiibstances and mimtures.

Sec. 5. Manufacturing and processing notices.

Sec. 6. Regulation of h/i^ardouschsmical substances arid miastures.

Sec. 7. Imminent hazards.

Sec. 8. Reporting and retention of information.

Sec. 9. Relationship to other Federal laws.

Sec. 10. Research, collection, dissemination, and utilization of data.
Sec. 11. Inspections.

• Line type deleted.
79-313 O - 77 - 20

298

103

TABLE OF CONTENTS— CoiitimieA
Sec. 12. Exports.

Sec. 13. Entry into customs territory of the United States.
Sec. llh Disclosure of data.
Sec. 15. Prohibited acts.
Sec. 16. Penalties.

Sec. 17. Specific enforcement and seizure.

Sec. 18. Preemption.

Sec. 19. Judicial review.

Sec. 20. Citizens'' civil actions.

Sec. 21. Citizens'' petitions.

Sec. 22. National defense waiver.

Sec. 23. Employee protection.

Sec. 2J^. Employment effects.

Sec. 26. Studies.

Sec. 26. Administration of Act.

Sec. 27. Development and evaluation of test methods.

Sec. 28. Authorization for appropriatio7i».

Sec. 29. AnnuM report.

Sec. 30. Effective date.

1 FINDINGS, POLICY, AND INTENT

2 Sec. 2. (a) Findings.— The Congress finds that^

3 (1) humans and the environment are being exposed

4 to a large number of chemical substances and mixtures

5 each year;

6 (2) among the many chemical substances and mix-
tures constantly being developed and produced are some

^ whose manufacture, processing, distribution in commerce,
^ use, or disposal may cause or significantly contribute to
1^ an unreasonable risk to health or the environment; and
1^ (3) the effective regulation of interstate commerce

in such chemical substances and mixtures also necessitates
the regulation of intrastate commerce in such chemical
substances and mixtures.

299
104

1 (b) Policy. — It is the policy of the United States that—

2 (1) hazardous and potentially hazardous chemical

3 substances and mixtures should be adequately tested with

4 respect to their effect on health and the environment and

5 that such testing should be the responsibility of those

6 who manufacture and those who process such chemical

7 substances and mixtures;

8 (2) adequate authority should exist to regulate

9 chemical substances and mixtures which cause or signifi-

10 cantly contribute to an unreasonable risk to health or the

11 environment, and to take action with respect to chemical

12 substances and mixtures which are imminent hazards;
1^ and

14 (3) authority over chemical substances and, mix-

15 tures should be exercised in such a manner as not un-
1^ duly to impede, or to create unnecessary economic bar-
1'^ riers to, technological innovation while fulfilling the
1® primary purpose of this Act to assure that such innova-
1^ tion and commerce in such chemical susbtances and

20 mixtures do not cause or significantly contribute to an

21 unreasonable risk to health or the environment.

22 (c) Intent of Congress. — It is the intent of Congress
2^ that the Administrator shall carry out this Act in a reason-
2^ able and prudent manner, and that the Administrator shall

300

105

1 consider the environmental, economic, and social impact of

2 any action the Administrator proposes to take under this Act.

3 DEFINITIONS

4 Sec. 3. As used in this Act:

5 (1) The term ^^Administrator'' means the Administrator

6 of the Environmental Protection Agency.

7 (2) (A) Except as provided in subparagraph (B), the

8 term "chemical substance'' means —

9 (i) any organic or inorganic substance of a par-

10 ticular molecular identity including a combination of

11 such substances occurring (I) in whole or in part as a

12 result of a chemical reaction, or (II) in nature, or

13 (ii) any element or uncombined radical.

14 (B) Such term does not include —

15 (i) any mixture,

16 (ii) any pesticide (as defined in the Federal In-
secticide, Fungicide, and Rodenticide Act) when manu-

1^ factured, processed, or distributed in commerce for use

19 as a pesticide,

20 (Hi) tobacco or any tobacco product,

21 (iv) any source material, special nuclear material,

22 or byproduct material ( as such terms are defined in the

23 Atomic Energy Act of 1954 and regulations issued

24 under such Act) ,

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1 (v) any article the sale of which is subject to the

2 ta<L imposed by section 4181 of the Internal Revenue

3 Code of 1954 (determined without regard to any ex-

4 emotions from such tax provided by section 4182 or 4221

5 or any other provision of such Code) , and

6 (vi) any food, food additive, drug, cosmetic, or

7 device (as such term^ are defined in section 201 of the

8 Federal Food, Drug, and Cosmetic Act) when manu-

9 factured, processed, or distributed in commerce for use

10 as a food, food additive, drug, cosmetic, or device.

11 The term "food" as used in clause (vi) of this subparagraph

12 includes poultry and poultry products ( as defined in sections

13 4(e) and 4(f) of the Poultry Products Inspection Act),

14 meat and m£at food products (as defined in section l(i) of

15 the Federal Meat Inspection Act), and eggs and egg prod-

16 ucts (as defined in section 4 of the Egg Products Inspection
1'7 Act).

18 (3J The term "commerce" means trade, traffic, or trans-

19 portation (A) between a place in a State and any place out-

20 side of such State, or (B) which affects trade, traffic, or

21 transportation described in clause (A).

22 (4) The term "distribute in commerce' or "distribu-

23 tion in commerce'' when used to describe an action taken

24 with respect to a chemical substance or mixture or article

25 containing a substance or mixture means to sellf or the sale

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107

1 of, the substance, mixture, or article in commerce; to in-

2 troduce or deliver for introduction into commerce, or the

3 introducing or delivery for introduction into commerce of,

4 the substance, mixture, or article; or to hold, or the holding

5 of, the substance, mixture, or article after its introduction

6 into commerce,

7 (5) The term environment^^ includes water, air, and

8 land and the interrelationship which exist among and be-

9 tween water, air, and land and all living things.

10 (6) The term ''health and safety study^' means any

11 study of any effect of a chemical substance or mixture on
' 2 health or the environment, including epidemiological studies,
13 studies of occupational exposure to a chemical substance or

mixture, toxicological, clinical, and ecological studies of a
chemical substance or mixture, and any test performed pur-
suant to this Act.

(7) The term "manufacture'' means to import, produce,

or manufacture.

^ a chemical reaction if each of the chemical substances com-

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108

1 prising the combination is not a new chemical substance and

2 if the combination could have been manufactured for commer-

3 cial purposes without a chemical reaction at the time the

4 chemical substances comprising the combination were com-

5 bined.

6 (9) The term ''new chemical substance^' means any

7 chemical substance not included in the chemical substance

8 list compiled and published under section 8(b).

9 (10) The term "process'' means the preparation of a

10 chemical substance or mixture for distribution in commerce —

11 (A) in the same form or physical state, or in a

12 different form or physical state from that, in which it

13 was received by the person making such preparation, or

14 (B) as part of an article containing the chemical

15 substance or mixture,

16 (11) The term "processor' means any person who

17 processes a chemical substance or mixture.

18 (12) The term "standards for the development of test

19 data" means a prescription of —

(A) the—

(i) health and environmental effects, and

(ii) information relating to toxicity, persistence,
- and other characteristics which affect health and the

environment,

for which test data for a chemical substance or mixture

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109

1 are to he developed and any analysis that is to he per-

2 formed on such data, and

3 (B) to the extent necessary to assure that such data

4 are reliable and adequate, the manner in which such

5 data are to be developed, the specification of any test

6 protocol or methodology to be employed in the develop-

7 ment of such data, and such other requirements as are

8 necessary to provide such assurance.

9 (13) The term "State" means any of the several States,

10 the District of Columbia, the Commonwealth of Puerto Bico,

11 the Virgin Islands, Guam, the Canal Zone, American

12 Samoa, or the Trust Territory of the Pacific Islands.

13 (14) The term "United States'', when used in the

14 geographic sense, means all the States.

15 TESTING OF CHEMICAL SUBSTANCES AND MIXTURES

1^ Sec. 4. (a) Testing Bequirements. — If the Ad-

1'^ ministrator finds that —

18 (l)(A)(i) the manufacture, distribution in com-

19 merce, processing, use, or disposal of a chemical sub-

20 stance or mixture or any combination of such actions

21 may cause or significantly contribute to an unreasonable

22 775^: to health or the environment,

23 (ii) there are insufficient data and experience upon

24 which the effects of such manufacture, distribution in

25 commerce, processing, use, or disposal or combination of

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110

1 such actions on health or the environment can reason-

2 a^ly be determined or predicted, and

3 (Hi) testing of such substance or mixture with

4 respect to such effects is necessary to develop such data;

5 or

6 (B)(i) a chemical substance or mixture is or will

7 he produced in substantial quantities, and it enters or

8 may reasonably be anticipated to enter the environment

9 in substantial quantities or there is or may be signifi-

10 cant or substantial human exposure to such substance or

11 mixture,

12 (ii) there are insufficient data and experience upon

13 which the effects of the manufacture, distribution in

14 commerce, processing, use, or disposal of such substance
1^ or mixture or any combination of such actions on health
16 or the environment can reasonably be determined or
1'^ predicted, and

18 (Hi) testing of such substance or mixture with re-

19 spect to such effects is necessary to develop such data;

20 and

21 (2) in the case of a mixture, the effects which the

22 mixture's manufacture, distribution in commerce, proc-
2^ easing, use, or disposal or any combination of such ac-
24 tions may have on health or the environment may not be
2^ reasonably and more efficiently determined or predicted

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111

1 by testing the chemical substances which comprise the

2 mixture;

3 the Administrator shall by rule require that testing be con-

4 ducted on such substance or mixture to develop data with

5 respect to the health and environmental effects for which

6 there is an insufficiency of daia and experience and which

7 are relevant to a determination that the manufacture, distri-

8 bution in commerce, processing, use, or disposal of such

9 substance or mixture or any combination of such actions does

10 or does not cause or significantly contribute to an unreason-

11 able risk to health or the environment.

12 (b)(1) Testing Requirement Rule.— A rule under

13 subsection (a ) requiring the testing of a chemical substance or

14 mixture shall include —

15 (A) identification of the substance or mixture for

16 which testing is required,

17 (B) standards for the development of test data for

18 such substance or mixture, and

19 (C) a specification of the period ( which period may

20 not be unreasonable) within which the persons required

21 to conduct the testing shall submit to the Administrator

22 data developed in accordance with the standards referred

23 to in subparagraph (B).

24 In determining the standards and period to be included, pur-

25 suant to subparagraphs (B) and (C), in a rule under sub-

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112

1 section (a), the Administrator shall consider the relative

2 costs of the various test protocols and methodologies which

3 may he required under the rule and the reasonably foreseeable

4 availability of facilities and personnel for performing testing

5 under the rule. Such a rule may require the submission of

6 preliminary data during the period prescribed under suh-

7 paragraph (C) .

8 (2) (A) The health and environmental effects for which

9 standards for the development of test data may be pre-

10 scribed include carcinogenesis, mutagenesis, terato genesis,

11 behavioral disorders, cumulative or synergistic effects, and

12 any other effect which may cause or significantly contribute

13 to an unreasonable I'isk to health or the environment, and

14 the characteristics of chemical substances and, mixtures for
which such standards may be prescribed include persistence,

1^ acute toxicity, subacute toxicity, chronic toxicity, and any
other characteristic which may cause or significantly con-

18 tribute to such a risk. The methodologies that may be pre-

19 scribed in such standards include epidemiology, serial, or

20 hierarchical tests; in vitro tests; and. whole animal tests.

21 Before prescribing epidemiology tests in such standards, the

22 Administrator shall consult with the Director of the National
2*^ Institute for Occupational Safety and Health.

24 (B) From time to time, but not less than once each

25 twelve months, the Administrator shall review the adequacy

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1 of the standards for development of data prescribed in rules

2 under subsection (a) and shall, if necessary, institute pro-

3 ceedings to make appropriate revisions of such standards.

4 (3) (A) A rule under subsection (a) respecting a chem-

5 ical substance or mixture shall require the persons described

6 in subparagraph (B) to conduct tests and submit data on

7 such substance or mixture, except that the Administrator may

8 permit two or more of such persons to designate one such

9 person or a qualified third party to conduct such tests and
10 submit such data on behalf of the persons making the
H designation.

12 (B) The following persons shall be required to conduct
tests and submit data on a chemical substance or mixture suh-

14 ject to a rule under subsection (a) :

15 (i) Each person who manufactures or intends to

16 manufacture such substance or mixture if the Adminis-
1^7 trafor makes a finding described in subsection (a)(1)

18 (A)(ii) or (a) (1) (B) (ii) with respect to the manu-

19 facture of such substance or mixture.

20 (ii) Each person who processes or intends to process

21 such substance or mixture if the Administrator makes a

22 finding described in subsection (a) (1) (A) (ii) or (a)

23 (l)(B)(ii) with respect to the processing of such
2^ substance or mixture.

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1 ( Hi) Each person who manufactures or processes or

2 intends to manufacture or process such substance or mix-

3 ture for diMrihution in commerce if with respect to the

4 distribution in commerce of such substance or mixture

5 the Administrator makes a finding described in siibsec-

6 tion (a)(l)(A)(ii) or ( a) (1) (B ) (ii) .

7 (iv) Each person who manufactures or processes oi'

8 intends to manufacture or process such substance or mix-

9 ture if with respect to the disposal of such substance or

10 mixture the Administrator makes a finding described

11 in subsection ( a) (1) ( A) (ii) or ( a) (1) (B ) (ii) .

12 (v) Each person who manufactures or processes or

13 intends to manufacture or process such chemical sub-

14 stance or mixture for a use with respect to which the

15 Administrator makes a finding described in subsection

16 (a) (1) (A) (ii) or (a) (1)(B) (ii).

17 ('^) A rule under subsection (a) requiring the testing of

18 a chemical substance or mixture shall expire at the end of the

19 reimbursement period (as defined in subsection (c) (3) (B) )

20 applicable to test data for such substance or mixture, unless

21 the Administrator repeals the rule before such date.

22 (5) Rules issued under subsection (a) (and any amend-

23 ment thereto or repeal thereof) shall be promulgated pur-

24 suant to section 553 of title 5, United States Code, except

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115

J that in promulgating, amending, or repealing any such rule

2 (A) the Administrator shall give interested persons an op-

3 portunity for the oral presentation of data, views, or argu-

4 ments, in addition to an opportunity to make written suh-

5 missions; and (B) a transcript shall he made of any oral
g presentation. The Administrator may not promulgate a rule
rj under subsection ( a) respecting a substance or mixture unless
g the Administrator makes and publishes with the rule the find-
9 ings described in paragraph (1) (A) or (1) (B) of such

10 subsection and, in the case of a rule respecting a mixture,

\1 the finding described in paragraph (2) of such subsection.

12 (c) Exemption— (1) Any person required by a rule

13 under subsection (a) to conduct tests and submit datd on a

14 chemical substance or mixture may apply to the Adminis-

15 trator ( in such form and manner as the Administrator shall

16 prescribe) for an exemption from such requirement.

17 (2) If, upon receipt of an application under paragraph

18 (1), the Administrator determines that —

19 (A) the chemical substance or mixture (including

20 any contaminant present in such substance or mixture)

21 with respect to which such application was submitted

22 is equivalent to a chemical substance or mixture for

23 which data has been submitted to the Administrator in

24 accordance with a rule under subsection (a) or for

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116

1 which data is being developed pursuant to such a rule,

2 and

3 (B) submission of data by the applicant on such

4 substance or mixture would be duplicative of data which

5 has been submitted to the Administrator in accordance

6 with such rule or which is being developed pursuant to

7 such rule,

8 the Administrator shall exempt, in accordance with para-

9 graph (3) or (4), the applicant from conducting tests and

10 submitting data on such substance or mixture.

11 (3) (A) If the exemption of any person from the re-

12 quirement to conduct tests and submit test data on a chemical

13 substance or mixture is granted on the basis of the existence

14 of previously submitted test data and if such exemption is

15 granted during the reimbursement period for such test data

16 (as prescribed by subparagraph (B)), then (unless such
1*7 person and the persons referred to in rlauses (i) and (ii)

18 agree on the amount and method of reimbursement) the Ad-

19 ministrator shall order the person granted the exemption to

20 provide fair and equitable reimbursement (in an amount

21 determined under rules of the Administrator) —

22 (i) to the person who previously submitted such test

23 data, for a portion of the costs incurred by such person
in complying with the requirement to submit such data,

^ and

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117

1 (ii) to any other person who has been required

2 under this subparagraph to contribute with respect to

3 such costs, for a portion of the amount such person was

4 required to contribute.

5 In promulgating rules for the determination of fair and

6 equitable reimbursement to the persons described in clauses

7 (i) and (ii) for costs incurred with respect to a chemical

8 substance or mixture, the Administrator shall consider all

9 relevant factors, including the effect on the competitive

10 position of the person required to provide reimbursement in

11 relation to the persons to be reimbursed and the share of the

12 market for such substance or mixture of the person re-

13 quired to provide reimbursement in relation to the share of

14 such market of the persons to be reimbursed. An order under

15 this subparagraph shall, for purposes of judicial review, be

16 considered final agency action .

17 (B) For purposes of subparagraph (A), the reimburse-

18 ment period for any test data for a chemical substance or

19 mixture is a period —

20 (i) beginning on the date such data was submitted

21 in accordance with a rule promulgated under subsection

22 (a), and

23 (ii) ending —

24 (I) five years after the date referred to in

25 clause (i), or

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118

1 (II) at the expiration of a period which begins

2 on the date referred to in clause (i) and is equal to

3 the period which the Administrator determines was

4 necessary to develop such data,

5 whichever is later.

6 (4) (A) If the exemption of any person from the require-

7 ment to conduct tests and submit test data on a chemical

8 substance or mixture is granted on the basis of the fact that

9 test data is being developed by one or more persons pursuant

10 to a rule promulgated under subsection (a), then ( unless such

11 person and the persons referred to in clauses (i) and (ii)

12 agree on the amount and method of reimbursement) the Ad-

13 ministrator shall order the person granted the exemption to
provide fair and equitable reimbursement (in an amount
determined under rules by the Administrator) —

(i) to each such person who is developing such test

data, for a portion of the costs incurred by each stick

person in complying with such rule, and

(a) to any other person who has been required

under this subparagraph to contribute with respect to

the costs of complying with such rule, for a portion of

the amount such person was required to contribute.

In promulgating rules for the determination of fair and

equitable reimbursement to the persons described in clauses

79-313 O - 77 - 21

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119

1 (i) and (ii) for costs incurred with respect to a chemical

2 substance or mixture, the Administrator shall consider the

3 factors described in the second sentence of paragraph (3)

4 (A). An order under this subparagraph shall, for purposes

5 of judicial review, be considered final agency action.

6 (B) If an exemption is granted on the basis of the fact

7 that one or more persons are developing test data pursuant to

8 a rule promulgated under subsection (a) and if after such

9 exemption is granted the Administrator determines that no

10 such person has complied with such rule, the Administrator

11 shall (i) after providing written notice to the person who

12 holds such exemption and an opportunity for a hearing, by

13 order terminate such exemption, and (ii) notify in writing
such person of the requirements of the rule with respect to
which such exemption was granted.

(d) Notice. — Upon the receipt of any test data pur-
suant to a rule under subsection (a), the Administrator shall,
subject to section 14, promptly publish a notice of the re-
ceipt of such data in the Federal Register. Each such notice
shall (1) identify the chemical substance or mixture for
which data have been received; (2) list the uses or intended
uses of such substance or mixture and the information re-
quired by the applicable standards for the development of
test data; and (3) describe the nature of the test data de-

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1 veloped. Except as otherwise provided in section 14, such

2 data shall he made available by the Administrator for ex-

3 amination by any person.

4 (e) Priority List.— (1) (A) There is established a

5 committee to make recommendations to the Administrator

6 respecting the chemical substances and mixtures to which the

7 Administrator should give priority consideration for the

8 promulgation of a rule under subsection (a). In making such

9 a recommendation with respect to any chemical substance or

10 mixture, the committee shall consider all relevant factors,

11 including —

12 (i) the quantities in which the substance or mix-

13 ture is or will be manufactured,

14 (ii) the quantities in which the substance or mixture

15 enters the environment,

16 (Hi) the number of persons who will be exposed to
1'7 the substance or mixture in their places of employment

18 and the duration of such exposure,

19 (iv) the extent of human exposure to the substance

20 or mixture,

21 (v) the extent to which the substance or mixture is

22 closely related to a chemical substance or mixture which

23 is known to cause or significantly contribute to an un-

24 reasonable risk to health or ihe environment.

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1 (vi) the existence of data concerning the effects of

2 the substance or mixture on health or the environment,

3 (vii) the extent to which testing of the substance

4 or mixture may result in the development of data upon

5 which the effects of the substance or mixture on health

6 or the environment can reasonably be determined or

7 predicted, and

8 ( viii) the reasonably foreseeable availability of facil-

9 ities and personnel for performing testing on the sub-

10 stance or mixture.

11 The recommendations of the committee shall be in the form

12 of a list of chemical substances and mixtures which shall

13 be listed, either by individual substance or mixture or by
groups of substances or mixtures, in the order in which
the committee determines the Administrator should take
action under subsection (a) with respect to the substances
and mixtures.

(B) Not later than twelve months after the effective
1^ date of this Act, the committee shall transmit to the
Administrator the list required by subparagraph (A) to-
'^^ gether with the reasons for the committee's inclusion of each
chemical substance or mixture on the lists. At least every six
months after the transmission to the Administrator of the
list pursuant to the preceding sentence, the committee shall

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122

make such revisions in the list as it determines to he neces-

2 sary and shall transmit them to the Administrator together

3 with the committee's reasons for th- ^'evisions. The Adminis-

4 trator shall make available to the public the list transmitted

5 by the committee, any revision by the committee in such list

6 (including the date on which such revision was transmitted

7 to the Administrator), and the reasons of the committee for
g inclusion of a chemical substance or mixture on the list and
9 for any revision in the list. The Administrator shall provide

10 reasonable opportunity to any interested person to file with

11 the Administrator written comments on the committee's list

12 or any revision of the committee of such list and shall make

13 such comments available to the public.

14 (C) The Administrator may promulgate a rule under

15 subsection (a) with respect to a chemical substance or mix-

16 ture which is not contained on a list published under this

17 subsection.

18 (2) (A) The committee established by paragraph (1)

19 (A) shall consist of eight members as follows:

20 (i) One member (or designee of the member) ap-

21 pointed from the Environmental Protection Agency by

22 the Administrator.

23 (ii) One member (or designee of the member)

24 appointed by the Secretary of Labor from officers of

25 the Department of Labor engaged in the Secretary's

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123

1 activities under the Occupational Safety and Health

2 Act of 1970.

3 (Hi) One member (or designee of the member)

4 appointed from the Council on Environmental Quality

5 by the Chairman of the Council.

6 (iv) One member (or designee of the member)

7 appointed from, the National Institute for Occupational

8 Safety and Health by the Director of the Institute.

9 (v) One member (or the designee of the member)

10 appointed from the National Institute of Environmental

11 Health Sciences by the Director of the Institute.

12 (vi) One member (or designee of the member)
appointed from the National Cancer Institute by the
Director of the Institute.

(vii) One member (or designee of the member)
appointed from the National Science Foundation by
the Director of the Foundation.

(viii) One member (or designee of the member)
appointed from the Department of Commerce by the
Secretary of Commerce.

A member may designate an individual to serve on the
member's behalf only with the approval of the applicable
appointing authority and only if the individual is from the
entity from which the member was appointed. A vacancy in

14
15
16
17
18
19
20
21
22
23
24

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1 the committee shall be filled in the same manner in which

2 the original appointment was made.

3 (B)(i) The term of office of a member of the committee

4 is four years, except that of the members first appointed,

5 four members shall have initial terms of two years. Any
Q member appointed to fill a vacancy occurring prior to the

7 expiration of the term for which the members predecessor

8 was appointed shall be appointed only for the remainder of

9 such term. If any member of the committee leaves the office

10 or entity from which the member was appointed, such mem-

11 ber may not continue as a member of the committee, and, for

12 purposes of the preceding sentence, the member s position

13 shall be considered as being vacant. A member may serve

14 after the expiration of the member's term of office until a

15 successor has taken office.

16 (a) Initial appointments to the committee shall be made

17 not later than the sixtieth day after the effective date of this

18 Act. Not later than the ninetieth day after such date the

19 members of the committee shall hold a meeting for the selec-

20 lion of a chairman from among their number and to deter-

21 mine, by lot, the four members ivho shall have initial terms

22 of two years.

23 (C) The Administrator shall provide the committee

24 such administrative support services as may be necessary for

25 the committee to carry out its function under this subsection.

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1 MANUFACTURING AND PROCESSING NOTICES

2 Sec, 5. (a) Notification for Manufacture of

3 New Chemical Substances —On and after the date on

4 which the Administrator first publishes under section 8(h)

5 a list of chemical substances manufactured or processed in

6 the United States, no person may manufacture a new

7 chemical substance unless (except as provided in subsection

8 (i) (relating to exemptions) ) such person —

9 (1) has, at least ninety days before such manu-

10 facture, submitted to the Administrator, in accordance

11 with subsection (f) (relating to notice content), a notice

12 of such person's intention to manufacture such sub-

13 stance, and

(2) has complied with any applicable requirement

1^ of subsection (d) (relating to submission of test data).

1^ (b) Notification for the Manufacture or Proc-

^'^ ESSiNG OF a Chemical Substance for a Significant

1^ New Use. — (1) No person may manufacture or process a

1^ chemical substance for a use which the Administrator has

20 determined, in accordance with paragraph (2), is a signifi-

21 cant new use of such substance unless (except as provided

22 in subsection (i) ) such person —

23 (A) has, at least ninety days before such manu-
2^ facture or processing, submitted to the Administrator, in
25 accordance with subsection (f), a notice of such person's

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126

1 intention to manufacture or process such substance for

2 such use, and

3 (B) has complied with any applicable requirement

4 of subsection (d).

5 (2) A determination by the Administrator that a new

6 use of a chemical substance is a significant new use with

7 respect to which notification is required under paragraph

8 (1) or subsection (c)(1)(B) shall be made by a rule

9 promulgated after a consideration of all relevant factors,

10 including —

11 (A) the projected volume of manufacturing and

12 processing of such substance for such use,

13 (B) the extent to which such use changes the type

14 or form of exposure of humans or the environment to
1^ such substance, and

1^ (C) the extent to which such use increases the mag-

nitude and duration of exposure of humans or the en-
1^ vironment to such substance.

1^ The last sentence of section 19(c)(1) shall not apply to

20 judicial review of any rule promulgated under this para-
graph.

22 (c) Notification for the Manufacture or Proc-

23 EssiNG OF Listed Chemical Substances.— (1) (A)

24 No person may manufacture a chemical substance —

25 (i) which is listed under paragraph (2), and

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127

1 (ii) which was a new chemical substance at the

2 time of publication of the earliest proposed rule under

3 paragraph (2) listing such substance,

4 unless ( except as provided in subsection (i) ) such person

5 ha^, at least ninety days before such manufacture, submitted

6 to the Administrator, in accordance with subsection (f), a

7 notice of such persons intention to manufacture such sub-

8 stance and has complied with the requirement of subsection

9 (d).

10 (B) No person may manufacture or process a chemical

11 substance, listed under paragraph (2), for a use which the

12 Administrator has determined, in accordance with subsection

13 (b)(2), is a significant new use of such substancp unless

14 (except as provided in subsection (i)) such person —

1^ (i) has, at least ninety days before such manufac-

1^ ture or processing, submitted to the Administrator, in
a^cordarice with subsection (f), a notice of such per-
1^ son^s intention to manufacture or process such substance

19 for such use, and

20 (a) has complied with the requirement of subsection

21 (d).

22 (2)(A)(i) Within twelve months after the effective date

23 of this Act, the Administrator shall, by rule, compile, and

24 from time to time thereafter revise, a Ivit of chemical sub-
2^ stances the manufacture, processing, distribution in com-

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128

1 merce, use, or disposal of which, or any combination of such

2 actions respecting which, the Administrator finds causes or

3 significantly contributes to or may cause or significantly con-

4 tribute to an unreasonable risk to health or the environment.

5 (ii) In making a finding under clause (i) that the

6 manufacture, processing, distribution in commerce, use, or

7 disposal of a chemical substance or any combination of such

8 actions causes or significantly contributes to or may cause or

9 significantly contribute to an unreasonable risk to health or

10 the environment, the Administrator shall consider all rele-

11 vant factors, including —

12 (I) the effects of the chemical substance on health

13 amd the magnitude of human exposure to it; and

14 (II) the effects of the chemical substance on the

15 environment and the magnitude of environmental ex-

16 posure to it.

17 (B) The Administrator shall, in prescribing a rule under

18 subparagraph (A) which lists any chemical substance,

19 identify those uses, if any, which the Administrator deter-

20 mines, in accordance with subsection (b)(2), would consti-

21 tute a significant new use of such substance. The last sen-

22 tence of section 19(c)(1) shall not apply to judicial revieiv

23 of any provision of a rule under subparagraph (A) which

24 provision is prescribed pursuant to this subparagraph.

25 (C) Any rule under subparagraph (A), and any

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129

1 amendment or repeal of such a rule, shall be promulgated

2 pursuant to the procedures specified in section 558 of title 5,

3 United States Code, except that (i) the Administrator shall

4 give interested persons an opportunity for the oral presenta-

5 tion of data, views, or arguments, in addition to an oppor-

6 tunity to make written submissions, and (ii) a transcript

7 shall he kept of any oral presentation. The Administrator

8 m,ay not promulgate under subparagraph (A) a rule listing

9 a chemical substance unless the Administrator makes and

10 publishes with the rule the finding described in such sub-

11 paragraph.

12 ( d) Requirement Respecting Submission of Test

13 Data.—(1)(A) If—

14 (i) a person is required by subsection (a), (b), or

15 (c) to submit a notice to the Administrator before be-
1^ ginning the manufacture or processing of a chemical

substance, and

1^ (ii) such person is required to submit test data for

19 such substance pursuant to a rule promulgated under

20 section 4 before the submission of such notice or such

21 person has been granted an exemption under section 4

22 (c) from the requirement of such rule,

2^ such person may not, before the expiration of the period pre-

2^ scribed by subparagraph (B), manufacture such substance
if the person is subject to subsection (a) or (c)(1)(A) or

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130

1 manufacture of process such substance for a significant new

2 use if the person is subject to subsection (b) or (c) (1) (B) .

3 (B) The period referred to in subparagraph (A) is —

4 (i) in the case of a person required to submit test

5 data pursuant to a rule promulgated under section 4 ( a)

6 a period of ninety days which begins on the date on

7 which such person submits to the Administrator such

8 data in accordance with such rule, and

9 (a) in the case of a person who under section 4(c)
10 is exempt from a requirement to submit test data pursu-
1.1 ant to a rule promulgated under section 4(a), a period of

2 ninety days which begins on the date of the submission in

13 accordance with such rule of the test data the submission

14 or the development of which was the basis for the

15 exemption.

16 (2) (A) If-

17 (i) a person is required by subsection (c) to sub-

18 mit a notice to the Administrator before beginning the

19 manufacture or processing of a chemical substance, and

20 (a) (I) a rule promulgated under section 4 before

21 the submission of such notice requiring the submission of

22 test data for such substance does not require such person

23 to submit such data, or

24 (II) the Administrator has not promulgated such a

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131

1 rule for such substance before the submission of such

2 notice,

3 such person may not, before the expiration of the ninety-day

4 period which begins on the date such person submits to the

5 Administrator data prescribed by subparagraph (B), manu-

6 facture such substance if such person is subject to subsection

7 (c)(1)(A) or manufacture or process such substance for a

8 significant new use if such person is subject to subsection

9 (c)(1)(B).

10 (B) Data submitted pursuant to subparagraph (A)

11 shall be data which the person submitting the data believes

12 show that —

13 (i) in the case of a substance for which notice is

14 required under subsection (c) (1) (A), the manufacture,

15 processing, distribution in commerce, use, and disposal

16 of the chemical substance or any combination of such

17 actions would not cause or significantly contribute to an

18 unreasonable risk to health or the environment, or

19 (ii) in the case of a chemical substance for which

20 notice is required under subsection (c) (1) (B) , the in-

21 tended significant new use of the chemical substance

22 would not cause or significantly contribute to an unrea-

23 sonable risk to health or the environment.

24 (3) Data submitted under paragraph (1) or (2) shall

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132

1 be made available, subject to section 14, for examination

2 by interested persons.

3 (e) Extension of Notice Period.— The Administrator

4 may for good cause extend for one additional period of

5 not to exceed ninety days the period, prescribed by subsec-

6 tion (a), (b), (c), or (d), before ivhich the manufacturing or

7 processing of a chemical substance subject to such subsection

8 may begin. Subject to section 14, such an extension and the

9 reasons therefor shall be published in the Federal Register

10 and shall constitute a final agency action subject to judicial

11 review.

12 (f) Content of Notice; Publication in the

13 Federal Register. — (1) The notice required by sub-

14 sections (a), (b), and (c) respecting a chemical substance

15 shall include —

16 (A) the name of the chemical substance;

1*7 (B) the chemical identity and molecular structure

18 of the substance, insofar as such are reasonably ascer-

19 tainable;

20 (C) the proposed categories of use of such sub-

21 stance, insofar as such are reasonably ascertainable;

22 (D) a reasonable estimate of the amount of the sub-

23 stance to be manufactured or processed and, insofar as

24 reasonably ascertainable, a reasonable estimate of the

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133

1 amount of the substance to be manufactured or proc-

2 essed for each proposed category of use of the substance;

3 (E) a description of the byproducts, if any, result-

4 ing from the manufacture, processing, use, or disposal of

5 the substance, insofar as such are reasonably ascertain-

6 able; and

7 (F) any test data in the possession or control of

8 the person giving such notice which are related to the

9 effect on health or the environment of any manufac-

10 ture, processing, distribution in commerce, use, or dis-

11 posal of the substance or any article containing such

12 substance,

13 Such a notice shall be made available, subject to section 14,
for examination by interested persons.

(2) Subject to section 14, not later than five days (ex-
eluding Saturdays, Sundays and legal holidays) after the
date of the receipt of a notice under subsection (a), (b), or
(c) or data under subsection (d) the Administrator shall
1^ publish in the Federal Register a notice which —

20 (A) identifies the chemical substance for which

21 notice or data has been received;

22 (B) lists the uses or intended uses of such sub-

23 stance; and

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134

1 section (d), describes the nature of the tests performed

2 on such substance and any data which was developed

3 pursuant to subsection (d) or a rule under section 4.

4 Notice under this paragraph respecting a chemical substance

5 shall identify the chemical substance by generic class unless
5 the Administrator determines that more specific identification

7 is required in the public interest.

8 (g) Regulation Pending Development of In-

9 formation .—(1) (A) The district courts of the United

10 States shall, upon application of the Administrator made

11 through attorneys of the Environmental Protection Agency,

12 have jurisdiction to enjoin in accordance tuith subparagraph

13 (B), the manufacture, processing, or distribution in coni-
1^ merce of a chemical substance subject to a notification require-
1^ ment of subsection (a), (b), or (c) if the court find.^ that —

(i) information available to the Administrator is
insufficient to permit a reasoned evaluation of the effects
on health or the environment of the manufacture, process-
1^ ing, distribution in commerce, use, or disposal of such

20 chemical substance or any combination of such actions,

21 and

22 (a) in the absence of such information, the manu-
2^ facture, processing, distribution in commerce, use, or dis-
2^ ■ posal of such substance or any combination of such actions

79-313 0 - 77 - 22

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135

1 may cause or significantly contribute to an unreasonable

2 risk to health or the environment.

3 (B) An injunction issued under subparagraph (A)

4 with respect to a chemical substance subject to a notification

5 requirement under subsection (b) or (c)(1)(B) respecting

6 a significant new use of such substance shall apply only to

7 the manufacture, processing, or distribution in commerce,

8 as the case may be, of the substance for such use.

9 (C) An injunction issued under subparagraph (A)

10 with respect to a chemical substance shall expire —

11 (i) upon the expiration of the five-day period be-

12 ginning on the day after the issuance of the injunction,
^'^ if the Administrator does not within such period publish

the notice required by paragraph (2), or

(ii) if the Administrator publishes such notice with-

in such period, upon the completion or termination of

the proceeding begun by publication of such notice.

(2) (A) Within five days after the issuance of an in-
junction under paragraph (1) ivith respect to a chemical
substance, the Administrator shall publish, in accordance
with section 553(b) of title 5, United States Code, a general
notice of proposed rulemaking to begin proceedings for the
promulgation of a rule to apply to such substance one or
^ more of the requirements described in section 6 ( a) as is

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136

1 necessary to adequately protect against the risk to health or

2 the environment found by the court under paragraph (1)

3 (A)(U).

4 (B) Upon publication of such a notice the Administrator

5 shall, as expeditiously as possible, provide reasonable oppor-

6 tunity for a hearing (in accordance with paragraphs (2)

7 and (3) of section 6(c)) on such proposed rule, and either

8 adopt such rule (as proposed or with modifications) or by

9 notice published in the Federal Register terminate the pro-

10 ceeding for the promulgation of the rule. If such a hearing

11 is requested, the Administrator shall commence the hearing

12 within fifteen days from the date such request is made unless

13 the Administrator and each person making the request agree
1^ upon a later date for the hearing to begin, and after the
1^ hearing is concluded the Administrator shall, within thirty

days of the conclusion of the hearing, either adopt such rule
■^'^ (as proposed or with modifications) or terminate the proceed-

ing (as prescribed in the preceding sentence).

(3) After a rule promulgated under paragraph (2) has

taken effect any person may petition the Administrator to
^■^ initiate a proceeding to amend or repeal such rule. Within

thirty days of the receipt of such a petition, the Adminis-

trator shall by order either grant or deny the petition. If the
^ Administrator grants such petition, the Administrator shall

promptly initiate a proceeding for the amendment or repeal,

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137

1 as the case may 6e, of such rule. Such a proceeding shall be

2 conducted in accordance with paragraphs (2) and (3) of

3 section 6(c).

4 (h) Petition for Standards for the Develop-

5 MENT of Test Data. — A person intending to manufacture

6 or process a chemical substance for which notice is required

7 under subsection (a), (b), or (c) and who is not required

8 under a rule under section 4 to conduct tests and submit data

9 on such substance may petition the Administrator to pre-

10 scribe standards for the development of test data for such

11 substance. The Administrator shall either grant or deny

12 any such petition within sixty days of its receipt. If the

13 petition is granted ^ the Administrator shall prescribe such
standards for such substance within seventy-five days of the

1^ date the petition is granted. If the petition is denied, the

1^ Administrator shall publish in the Federal Register the

reasons for such denial.
1^ (i) Exemption. — (1) The Administrator may, upon

1^ application (made in such form and manner as the Ad-

20 ministrator may prescribe) exempt any person from the re-

21 quirement of subsection (a), (b), (c), or (d) or of any

22 combination of such subsections to enable such person to
2^ manufacture or process a chemical substance for test market-

ing purposes —

25 (A) upon a showing by such person satisfactory

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138

"1^ to the Administrator that the manufacture, processing,

2 distribution in commerce, use, and disposal of such suh-

3 stance for such purposes would not cause or significantly

4 contribute to any unreasonable risk to health or the envi-

5 ronment, and

6 (B) under such restrictions as the Administrator

7 considers appropriate.

8 Within forty-five days of the receipt of an application under

9 this paragraph the Administrator shall either approve

10 deny such application.

11 (2) (A) The Administrator may upon application

12 (made in such form and manner as the Administrator may

13 prescribe) exempt any person from the requirement of sub-

14 section (d)(2) to submit data for a chemical substance.
1'^ //, upon receipt of an application under the preceding sen-
1^ tencey the Administrator determines that —

( i) the chemical substance ( including any contami-
nant present in such substance) with respect to which

19 such application was submitted is equivalent to a chemi-

20 cal substance for which data has been submitted to the

21 Administrator in accordance with subsection (d)(2),

22 and

2^ (a) submission of data by the applicant on such

24 substance would be duplicative of data which has been

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139

1 submitted to the Administrator in accordance with such

2 subsection,

3 the Administrator shall exempt the applicant from submit-

4 ting such data on such substance. No exemption granted

5 under this subparagraph with respect to the submission of

6 data for a chemical substance may take effect before the

7 beginning of the reimbursement period applicable to such

8 data.

9 (B) If the Administrator, under subparagraph (A),

10 exempts any person from submitting under subsection (d)

11 (2) data for a chemical substance because of the existence of

12 previously submitted data and if such exemption is granted

13 during the reimbursement period for such data, then ( unless
such person and the persons referred to in clauses (i) and
(ii) agree on the amount and method of reimbursement)
the Administrator shall order the person granted the exemp-
tion to provide fair and equitable reimbursement (in on
amount determined under rides of the Administrator) —

(i) to the person who previously submitted the
29 data on which the exemption icas based, for a portion of
2-^ the costs incurred by such person in complying with the
22 requirement under subsection (d)(2) to submit such
2^ data, and

2^ ( ii) to any other person who has been required

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140

1 under this subparagraph to contribute with respect to

2 such costs, for a portion of the amount such person was

3 required to contribute.

4 In promulgating rules for the determination of fair and

5 equitable reimbursement to the persons described in clauses
Q (i) and (ii) for costs incurred with respect to a chemical

7 substance, the Administrator shall consider all relevant fac-

8 tors, including the effect on the competitive position of the

9 person required to provide reimbursement in relation to the

10 persons to be reimbursed and the share of the market for

11 such substance of the person required to provide reimburse-

12 ment in relation to the share of such market of the persojis to

13 be reimbursed. An order under this subparagraph shall be

14 considered final agency action, for purposes of judicial

15 review.

16 (C) For purposes of this paragraph, the reimbursement

17 period for any previously submitted data for a chemical sub-

18 stance is a period —

19 ' (i) beginning on the date of the termination of the

20 prohibition, imposed under this section, on the manufac-

21 ture or processing of such substance by the person who

22 submitted such data to the Administrator, and

23 (ii) ending —

24 (I) five years after the date referred to in

25 clause (i), or

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141

1 (II) at the expiration of a period which begins

2 on the date referred to in claibse (i) and is equal

3 to the period which the Administrator determines

4 wa^ necessary to develop such data,

5 whichever is later,

6 (3) The requirements of subsections (a), (b), (c), and

7 (d) do not apply with respect to the manufacturing or

8 processing of any chemical substance which is manufactured

9 or processed, or proposed to be manufactured or processed,

10 only in small quantities (as defined by the Administrator by

11 rule) solely for —

12 (A) scientific experimentation or analysis, or

1*^ (B) chemical research or analysis on such sub-

14 stance or another substance, including such research or

15 analysis for the development of a product,

16 if all persons engaged in such experimentation, research, or

17 analysis for a manufacturer or processor are notified ( in such

18 form and manner as the Administrator may prescribe) of

19 any risk to health which the manufacturer or processor has

20 reason to believe may be associated with such chemical

21 substance.

22 (4) (A) The requirements of subsections (a) and (c)

23 (1) (A) do not apply with respect to the manufacturing or

24 processing of any chemical substance which is the same as a

25 listed chemical substance.

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142

1 (B) For purposes of subparagraph (A), a chemical

2 substance shall not be considered as different from a listed

3 chemical substance solely because —

4 (i) the proportion of the inert chemical substances

5 which are present in the listed chemical substance is dif-

6 ferent from the proportion of such substances present in

7 the chemical substance being compared to the listed

8 chemical substance; or

9 (a) an inert listed chemical substance has been

10 added to or deleted from the chemical substance being

11 compared.

12 (C) For purposes of this paragraph —

IS (i) the term ''inert chemical substance' means a

1^ chemical substance which when combined with other

1^ chemical substances to produce another chemical sub-

1^ stance does not react chemically with such other chemi-
cal substances; and

(a) the term "listed chemical substance" means a

1^ chemical substance included in the list compiled and

2^ published under section 8(b).

21 (5) The Administrator may, upon application, by

22 rule exempt the manufacturer of any new chemical sub-
2S stance from all or part of the requirements of this section if
2^ the Administrator determines that such chemical substance
2^ will not cause or significantly contribute to an unreasonable

338

143

1 risk to health or the environment. A rule under this para-

2 graph ( and any substantive amendment to, or repeal of, such

3 a rule) shall be promulgated in accordance with paragraphs

4 (2) and (3) of section 6(c).

5 (j) Definition. — For purposes of this section, the

6 terms ^'manufacture" and " process' ' mean to manufacture

7 or to process for commercial purposes.

8 REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES

9 AND MIXTURES

10 Sec. 6. ( a) Scope of Regulation.— If the Adminis-

11 trator finds that there is a reasonable basis to conclude that

12 the manufacture, processing, distribution in commerce, use,

13 or disposal of a chemical substance or mixture or any com-

14 bination of such actions causes or significantly contributes to

15 or will cause or significantly contribute to an unreasonable
1^ risk to health or the environment, the Administrator shall by
1'^ rule apply to such substance or mixture one or more of the

following requirements as is necessary to adequately protect
1^ against such risk:

20 (1) ^ requirement prohibiting the manufacturing,

processing, or distribution in commerce of such substance

22 or mixture or limiting the amount of such substance or
mixture which may be manufactured, processed, or dis-

24 tributed in commerce.

(2) A requirement —

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144

1 (A) prohibiting the manufacture, processing

2 or distribution in commerce of such substance or

3 mixture for (i) a particular use or (ii) a particular

4 use in a concentration in excess of a level specified

5 by the Administrator in the rule imposing the re-

6 quirement, or

7 (B) limiting the amount of such substance or

8 mixture which may be manufactured, processed,

9 or distributed in commerce for (i) a particular use

10 or ( ii) a particular use in a concentration in excess

11 of a level specified by the Administrator in the rule

12 imposing the requirement.

io (3) A requirement that such substance or mixture

14 or any article containing such substance or mixture be

15 marked with or accompanied by clear and adequate

16 warnings and instructions with respect to its use or dis-
1*^ posal or with respect to both. The form and content of

18 su^ih warnings and instructions shall be prescribed by

19 the Administrator.

20 (4) A requirement that manufacturers and proc-

21 essors of such substance or mixture make and retain

22 records of the processes used to manufacture or process

23 such substance or mixture.

24 (5) (A) A requirement regulating the manner or

25 method of disposal of such substance or ■ mixture or

340

145

1 article containing such substance or mixture by its

2 manufacturer or processor or any other person who

3 v^es it for commercial purposes.

4 (B) A requirement under subparagraph (A) may

5 not require any person to take any action which would

6 be in violation of any law of a State or political subdivi-

7 sion, and shall require each person subject to it to notify

8 each State and political subdivision in which a required

9 disposal may occur of such requirement.

10 (6) If the rule imposes on a chemical substance

11 or mixture a requirement described in paragraph (1)

12 or (2), a requirement directing the manufacturer, proc-

13 essor, or distributor in commerce of such substance or
mixture or article containing such substance or mixture
or directing any combination of such persons (A) to
to give notice of such risk to processors or distributors

^'^ in commerce of such substance, mixture, or article, or

to both, and, to the extent reasonably ascertainable, to
1^ any other person in possession of or exposed to such

20 substance, mixture, or article; (B) to give public notice

21 of such risk; or (C) to give both such notices.

22 A requirement imposed under this subsection shall be the

23 least burdensome requirement necessary to adequately pro-

24 tect against the risk with respect to which the requirement

341

146

1 was imposed and may be limited in application to specified

2 geographic areas,

3 (b) Protection Against Adulteration or Con-

4 TAMINATION OF SUBSTANCES AND MIXTURES.— If the

5 Administrator has good cause to believe thai a particular

6 manufacturer or processor is manufacturing or processing a

7 chemical substance or mixture in a manner which uninten-'

8 tionally causes the chemical substance or mixture to cause

9 or significantly contribute to or to be likely to cause or sig-

10 nificantly contribute to an unreasonable risk to health or the

11 environment —

12 (1) the Administrator may by order require such

13 manufacturer or processor to submit a description of

14 the relevant quality control procedures followed in the

15 manufacturing or processing of such chemical substance

16 or mixture; and

l'^ (2) if the Administrator determines after the issur

18 ance of an order described in paragraph (1) —

19 (A) that such quality control procedures are

20 inadequate to prevent the chemical substance or mix-

21 ture from causing or significantly contributing to

22 siuih risk, the Administrator may order the manu-

23 facturer or processor to revise such quality control

24 procedures to the extent necessary to remedy such

25 inadequacy; or

342
147

(B) that the use of such quality control proce-
dures has resulted in the distribution in commerce
of chemical substances or mixtures which cause or
significantly contribute to an unreasonable risk to
health or the environment, the Administrator may
order the manufacturer or processor to (i) give
notice of such risk to processors or distributors in
commerce of any such substance or mixture, or to
both, and, to the extent reasonably ascertainable, to
any other person in possession of or exposed to any

11 such subsance, (ii) to give public notice of such

12 risk, and (Hi) to provide such replacement or re-

13 purchase of any such substance or mixture as is

14 necessary to adequately protect health or the en-

15 • vironment.

16 A determination under subparagraph (A) or (B) of para-

17 graph (2) shall be made on the record after opportunity for

18 hearing in accordance with section 554 of title 5, United

19 States Code. The manufacturer or processor subject to a

20 requirement to replace or repurchase a chemical substance

21 or mixture may decide whether to replace or repurchase the

22 substance or mixture and shall take either such action in the

23 manner prescribed by the Administrator.

24 (c) Promulgation of Subsection (a) Rules.—

25 (1) In promulgating any rule under subsection (a) with

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148

^ respect to a chemical substance or mixture, the Administra-
tor shall consider all relevant factors and make findings
with respect to —

^ (A) the effects of such substance or mixture on

health and the magnitude of human exposure to such
_ substance or mixture,

^ (B) the effects of such substance or mixture on the

g environment and the magnitude of environmental expo-
^ sure to such substance or mixture,

j2 mixtures for such uses, and

(D) the reasonably ascertainable economic conse-
24 quences of such rule taking into account the impact on
j5 small business.

If the Administrator determines that a risk to health or the
17 environment could be eliminated or reduced to a sufficient
Ig extent by actions taken under another Federal law (or

19 laws) administered in whole or in part by the Administra-

20 ihe Administrator may not promulgate a rule under

21 subsection (a) to protect against such risk unless the Admin-

22 istrator makes a finding that it is in the public interest

23 to protect against such risk under such rule taking into con-

24 sideration all aspects of the risk, the authorities under this

25 Act and such other law (or laws) to enforce actions taken

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149

1 under this Act or such law (or laws) to protect against such

2 risk, a comparison of the estimated costs of complying with

3 actions taken under this Act and under such law (or laws),

4 and the relative efficiency of actions under this Act and

5 under such law (or laws). In the judicial review of a rule

6 under subsection (a) the last sentence of section 19(c)(1)

7 shall not apply with respect to the determinations and find-

8 ings required to be made by this paragraph.

9 (2) (A) Rules under subsection (a) shall be promul-

10 gated pursuant to section 558 of title 5 of the United States

11 Code; except that in promulgating any such rule (i) the

12 Administrator shall give interested persons an opportunity
1^ for the oral presentation of data, views, or arguments, in
1^ addition to an opportunity to make written submissions; (ii)
1^ a transcript shall be kept of any oral presentation; and (Hi)

during any such oral presentation, the Administrator shall
^''^ include an opportunity for cross-examination as provided

in subparagraph (B). The Administrator may not promul-
1^ gate a rule under subsection (a) respecting a chemical sub-

20 stance or mixture unless the Administrator makes and pub-

21 lishes with the rule the finding described in such subsection.

22 (B) An interested person is entitled, if the Administra-
tor determines that it is necessary to resolve disputed issues

24 of material fact, to conduct or have conducted by the Ad-
2*^ ministrator such cross-examination of persons as the Admin-

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150

1 istrator determines (i) to be appropriate in view of any

2 need for expedition, the nature of the issues involved, and

3 the number of participants and the nature of their interests,

4 and ( ii) to be required for a full and true disclosure with

5 respect to such issues.

6 (C)(i) If the Administrator determines that a group

7 of persons, each of whom would but for this subparagraph

8 be entitled to conduct (or have conducted) cross-examina-

9 tion, has the same or similar interests in a proceeding, the

10 Administrator may (I) conduct cross-examination on behalf

11 of such group, or (II) require such group to designate a

12 single representative of such interests for purposes of con-

13 ducting cross-examination in such proceeding and such rep-
resentative shall, except as provided in clause (ii), conduct
such cross-examination. If such group cannot agree upon a
single representative for such purposes, the Administrator
may limit the representation of such interests for such

-IQ

purposes.

( ii) When any person who is a member of a group with
respect to which the Administrator has made a determina-
tion under clause (i) is unable to agree upon group repre-

sentation with the other members of the group, then such

person shall not be denied under the authority of such clause

^ the opportunity to conduct (or have conducted) cross-exami-
25

nation as to issues affecting the person's particular interests

79-313 O - 77 - 23

346

151

1 if (I) the person satisfies the Administrator that the person

2 has made a reasonable and good faith effort to reach agree-

3 ment upon group representation with the other members of

4 the group and (II) the Administrator determines that there

5 are substantial and relevant issues which are not adequately

6 presented by the group representative.

7 (D) The Administrator may issue procedural rules

8 for the conduct of any oral presentation (including cross-

9 examination) under this paragraph and may impose such

10 reasonable time limits on each persons oral presentations

11 authorized by this paragraph as may be appropriate in view

12 of any need for expeditioUj the nature of the issues involvedy

13 and the number of participants and the nature of their
interests.

(E) In the judicial review of a ride under subsection
(a) the last sentence of section 19(c)(1) shall not apply to
^'^ any determination of the Administrator under this paragraph.
^® (3) (A) The Administrator may, pursuant to rules pre-
1^ scribed by it, provide compensation for reasonable attorneys^
2^ fees, expert witness fees, and other costs of partimpating in a
rulemaking proceeding for the promulgation of a rule under
subsection (a) to any person who represents an interest
which will substantially contribute to a fair determination of
^ the issues to be resolved in the proceeding taking into account
the number and complexity of such issues and whether rep-

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152

1 resentation of such interest will contribute to widespread

2 public participation in the proceeding and representation

3 of a fair balance of interests for the resolution of such issues

4 if—

5 (i) the economic interest of such person is small in

6 comparison to the costs of effective participation in the

7 proceeding by such person^ or

8 (ii) such person demonstrates to the satisfaction of

9 the Administrator that such person does not have suffi-

10 dent resources adequately to participate in the proceed-

11 ing in the absence of compensation under this subpara-

12 graph.

13 In determining whether compensation should be provided
to a person under this subparagraph and the amount of such
compensation, the Administrator shall take into account the

1fi

financial burden which will be incurred by such person in

participating in the rulemaking proceeding.

(B) The aggregate amount of compensation paid under
this paragraph in any fiscal year to all persons who, in rule-
making proceedings in which they receive compensation, are

persons who either —

(i) would be regulated by the proposed rule, or

23 J

(ii) represent persons who would be so regulated,

^ may not exceed 25 per centum of the aggregate amount

348

153

1 paid as compensation under this paragraph to all persons

2 in such fiscal year.

3 (4) Paragraphs (1), (2), and (3) of this subsection

4 apply to the promulgation of a rule repealing, or making

5 a substantive amendment to, a rule promulgated under sub-

6 section (a).

7 (d) Effective Date.—(1) The Administrator shall

8 specify in any rule under subsection (a) the date on which it

9 shall take effect, which date shall be as soon as feasible.

10 (2) (A) The Administrator may declare a proposed

11 rule under subsection (a) to be effective upon its publication

12 in the Federal Register and until the effective date of final

13 action taken, in accordance with subparagraph (B), respect-
ing such rule if —

(i) the Administrator determines that —

(I) the manufacture, processing, distribution

in commerce, use, or disposal of the chemical sub-
stance or mixture subject to such proposed rule or
any combination of such activities is likely to result
in an unreasonable risk of serious or widespread
harm to health or the environment before such effec-

tive date; and

(II) making such proposed rule so effective
^ is necessary to protect the public interest; and

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2 (a) in the case of a proposed rule to prohibit the

2 manufacture, processing, or distribution of a chemical

3 substance or mixture because of the risk determined un-

4 der clause (i) (I), a court has in an action under section

5 7 granted relief with respect to such risk associated with

6 such substance or mixture.

7 (B) If the Administrator makes a proposed rule effec-

8 tive upon its publication in the Federal Register, the Ad-

9 ministrator shall, as expeditiously as possible, give interested

10 persons prompt notice of such action, provide reasonable

11 opportunity, in accordance with paragraphs (2) and (3)

12 of subsection (c), for a hearing on such rule, and either

13 affirm such rule (as proposed or with modifications) or re-

14 voke it; and if such a hearing is requested, the Administrator

15 shall commence the hearing within five days from the date

16 such request is made unless the Administrator and the person

17 making the request agree upon a later date for the hearing

18 to begin, and after the hearing is concluded the Administrator

19 shall, within ten days of the conclusion of the hearing, either

20 affirm such rule ( as proposed or with modifications) or re-

21 voke it.

22 IMMINENT HAZARDS

23 Sec. 7. (a) Actions Authorized and Required.—

24 (1) The Administrator may file an action in a district court

25 of the United States —

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1 (A) for seizure of an imminently hazardous chemi-

2 cal substance or mixture or any article containing such

3 a substance or mixture,

4 (B) for relief (as authorized by subsection (b) )

5 against any person who manufactures, processes, or

6 distributes in commerce an imminently hazardous chemi-

7 cal substance or mixture or any article containing such

8 a substance or mixture, or

9 (C) for both such seizure and relief.

10 An action may be filed under this paragraph notwithstand-

11 ing the existence of a rule under section 4, 5, or 6, and not-

12 withstanding the pendency of any administrative or judicial
1^ proceeding under any provision of this Act.

1*^ (2) If the Administrator has not made a rule under

1^ section 6(a) imm£diately effective (as authorized by sub-
1^ section 6(d) (2) (A) (i) ) with respect to an imminently haz-
1'^ ardous chemical substance or mixture, the Administrator

shall file in a district court of the United States with respect
1^ to such substance or mixture or article containing such sub-

stance or mixture an action described in subparagraph (A),

(B), or (C ) or paragraph (1 ) .

(b) Jurisdiction of Court.— (1) The district court

of the United States in which an action under subsection ( a)
^ is broug}it shall have jurisdiction to grant such temporary

or permanent relief as may be necessary to protect health

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156

1 or the environment from the unreasonable risk associated

2 with the chemical substance^ mixture, or article involved in

3 such action.

4 (2) In the case of an action under subsection (a)

5 brought against a person who manufactures, processes, or

6 distributes in commerce a chemical substance or mixture or

7 an article containing a chemical substance or mixture, the

8 relief authorized by paragraph (1) may include the issuance

9 of a mandatory order requiring (A) in the case of purchasers

10 of such substance, mixture, or article known to the defendant,

11 notification to such purchasers of the risk associated with it;

12 (B) public notice of such risk; (C) recall; (D) the re-

13 placement or repurchase of such substance, mixture, or

14 article; or (E) any combination of the actions described

15 in the preceding clauses.

16 (3) In the case of an action under subsection (a) against

17 a chemical substance, mixture, or article, such substance,

18 mixture, or article may be proceeded against by process of

19 libel for its seizure and condemnation. Proceedings in such

20 an action shall conform as nearly as possible to proceedings

21 in rem in admiralty.

22 (c) Venue and Consolidation.— (1) (A) An action

23 under subsection (a) against a person who manufactures,

24 processes, or distributes a chemical substance or mixture or

25 an article containing a chemical substance or mixture may be

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157

1 brought in the United States District Court for the District

2 of Columbia or for any judicial district in which any of the

3 defendants is founds resides^ or transacts business; and

4 process in such an action may be served on a defendant in

5 any other district in which such defendant resides or may

6 be found. An action under subsection (a) against a chemical

7 substancCy mixture^ or article may be brought in any United

8 States district court within the jurisdiction of which the sub-

9 stance, mixture, or article is found.

10 (B) In determining the judicial district in which an

11 action may be brought under subsection (a) in instances in

12 which such action may be brought in more than one judicial

13 district, the Administrator shall take into account the ^con-

14 venience of the parties.

15 (C) Subpenas requiring attendance of witnesses in an

16 action brought under subsection ( a) may run into any judi-
1'^ cial district.

18 (2) Whenever proceedings under subsection (a) in-

19 volving identical chemical substances, mixtures, or articles

20 are pending in courts in two or more judicial districts, they

21 shall be consolidated for trial by order of any such court

22 upon application reasonably made by any party in interest,

23 upon notice to all parties in interest.

24 (d) Action Under Section 6.— Where appropriate,

25 concurrently with the filing of an action under subsection ( a)

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1 or as soon thereafter as may be practicable, the Administrator

2 shall initiate a proceeding for the promulgation of a rule

3 under section 6(a).

4 (c) Representation. — Notwithstanding any other

5 provision of law, in any action under subsection (a), the

6 Administrator may direct attorneys of the Environmental

7 Protection Agency to appear and represent the Administra-

8 tor in such an action.

9 (f) Definition. — For purposes of subsection (a), the

10 term ''imminently hazardous chemical substance or mixture^^

11 means a chemical substance or mixture which causes or

12 significantly contributes to an imminent and unreasonable

13 risk of serious or widespread harm to health or the environ-
1^ ment. Such a risk to health or the environment shall be con-
1^ sidered imminent if it is shown that the manufacture, proc-
1^ essing, distribution in commerce, use, or disposal of the

chemical substance or mixture or any combination of such
actions is likely to result in such harm to health or the envi-

1^ ronment before a final rule under section 6 can protect

2^ against such risk.

21 REPORTING AND RETENTION OF INFORMATION

^ Sec. 8. (a) Reports. — (1) The Administrator shall

promulgate rules under which —

^ (A) each person (other than a small manufacturer

^ or processor) who manufactures or processes or proposes

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159

1 to manufacture or process a chemical substance (other

2 than a chemical substance described in subparagraph

3 ii) ) shall maintain such records^ and shall submit

4 to the Administrator such reports, as the Administrator

5 may reasonably require, and

6 ( B) each person ( other than a small manufacturer

7 or processor) who manufactures or processes or proposes

8 to manufacture or process —

9 (i) a mixture J or

(ii) a chemical substance in small quantities
•^^ (as defined by the Administrator by rule) solely for

^2 scientific experimentation or analysis or for chemical

1^ research or analysis on such susbtance or another

substance, including such research or analysis for
the development of a product,
shall maintain records and submit to the Administrator
^'^ reports but only to the extent the Administrator deter-
mines the maintenance of records or submission of
reports, or both, is necessary for the effective enforcement
^ of this Act.

The Administrator may not require in a rule promulgated
under this paragraph the maintenance of records or the sub-
mission of reports with respect to changes in the proportions
^ of the components of a mixture unless the Administrator finds
^ that the maintenance of such records or the. submission of such

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160

1 reports^ or both, is necessary for the effective enforcement of

2 this Act. For purposes of the compilation of the list of chemi-

3 cal substances required under subsection (b), the Administra-

4 tor shall promulgate rules pursuant to this subsection not later

5 than one hundred and eighty days after the effective date of

6 this Act.

7 (2) The Administrator may require under paragraph •

8 (1) reporting with respect to the following:

9 (A) The common or trade name, the chemical

10 identity, and the molecular structure of each chemical

11 substance or mixture for which such a report is required,

12 insofar as known to the person making the report or

13 insofar as reasonably ascertainable.

14 (B) The categories or proposed categories of use

15 of each such substance or mixture, insofar as known to

16 the person making the report or insofar a^ reasonably

17 ascertainable.

18 (C) Reasonable estimates of the amount of each

19 substance and mixture to be manufactured or processed

20 and, insofar as known to the person making the report

21 or insofar as reasonably ascertainable, a reasonable esti-

22 mate of the amount of each such substance and mixture

23 to be manufactured or processed for each of its categories

24 or proposed categories of use.

25 (D) A description of the byproducts resulting from

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161

1 the manufacture^ processing, use, or disposal of each such

2 substance or mixture, insofar as known to the person

3 making the report or insofar as reasonably ascertainable.

4 (E) All existing data concerning the adverse en-

5 vironmental and health effects of such substance or mix-

6 ture, insofar as known to the person making the report.

7 (F) Estimates of the number of persons who will

8 be exposed to such substance or mixture in their places

9 of employment and the duration of such exposure, inso-

10 far as known to the person making the report.

11 To the extent feasible the Administration shall not require

12 under paragraph (1) unnecessary or duplicate reporting.

13 (3)(A)(i) The Administrator may by rule require a

14 small manufacturer or processor of a chemical substance to

15 submit to the Administrator such information respecting the
1^ chemical substance as the Administrator may require for
l'^ publication of the first list of chemical substances required
1^ by subsection (b).

19 (ii) The Administrator may by rule require a small

20 manufacturer or processor of a chemical substance or mix-

21 ture —

22 (ij subject to a rule proposed or promulgated under

23 section 4, 5(c) , 5(g), or 6, or

24 (II) with respect to which relief has been granted
2^ pursuant to a civil action brought under section 7,

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162

1 to maintain such records on such substance or mixture, and

2 to submit to the Administrator such reports on such sub-

3 stance or mixture, as the Administrator may reasonably

4 require. A rule under this clause requiring reporting may

5 require reporting with respect to the matters referred to

6 in paragraph ( 2) .

7 (B) The Administrator, after consultation with the Ad-

8 ministrator of the Small Business Administration, shall by

9 rule prescribe standards for determining the manufacturers
1^ and processors which qualify as small manufacturers and

11 processors for purposes of this paragraph and paragraph

12 (1).

1^ (b) Inventory. — (1) The Administrator shall com-
14

pile, keep current, and publish a list of each chemical sub-

15 . .

stance which is manufactured or processed in the United

States. Such list shall at least include each chemical sub-

stance which any person reports, under section 5 or sub-

section (a) of this section, is manufactured or processed in

the United States or was manufactured or processed in the

United States within three years before the effective date of

the rules promulgated pursuant to the last sentence of suh-

section (a) (1) . In the case of a chemical substance for which

a notice is submitted in accordance with section 5, such

chemical substance shall be included in such list as of the

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163

1 earliest date (as determined by the Administrator) on which

2 such substance was manufactured or processed in the United

3 States. The Administrator shall first publish such a list not

4 later than one year after the effective date of this Act, The

5 Administrator shall not include in such list any chemical

6 substance which is manufactured or processed only in small

7 quantities (as defined by the Administrator by rule) solely

8 for scientific experimentation or analysis or for chemical

9 research or analysis on such substance or another substance,

10 including such research or analysis for the development of a

11 product.

12 (2) To the extent consistent with the purposes of this

13 Act, the Administrator may, in lieu of listing, pursuant to
paragraph (1), a chemical substance individually, list a
category of chemical substances in which such substance is
included.

(c) Records, —Any person who manufactures, proc-
esses, or distributes in commerce or proposes to manufacture,
process, or distribute in commerce any chemical substance or
mixture shall, as required by the Administrator by rule,
maintain records of adverse reactions to health or the envi-
ronment alleged to have been caused by the substance or
mixture. In such a rule the Administrator may require that —
^ (1) records of adverse reactions to the health of

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164

1 employees he retained for a period of not more than fifty

2 years from the date such reactions were first reported to

3 or known by the person maintaining such records^ and

4 (2) any other record be retained for a period of

5 not more than five years from the date the information

6 contained in the record was first reported to or known by

7 the person maintaining the record,

8 Records required to be maintained under this subsection may

9 include records of consumer allegations of personal injury

10 or harm to health, reports of occupational disease or injury,

11 and reports or complaints of injury to the environment

12 submitted to the manufacturer, processor, or distributor in

13 commerce by individuals or governmental agencies. Upon

14 request of an officer or employee duly designated by the Ad-

15 ministrator, each person who is required to maintain records
1^ under this subsection shall permit the inspection of such
1'^ records and shall submit copies of such records.

18 (d) Health and Safety Studies. — The Adminis-

19 trator shqll promulgate rules under which the Administrator

20 may require any person who manufactures, processes, or dis-

21 tinhutes in commerce or who proposes to manufacture, proc-

22 ess, or distribute in commerce any chemical substance or mix-

23 ture (or with respect to paragraph (2), any person who
^ has possession of a study) to submit to the Administrator —

(1) lists of health and safety studies conducted or

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165

1 initiated by or for such person at any time or known

2 to such person; and

3 (2) copies of any such studies appearing on a list

4 submitted pursuant to paragraph (1) or (2), or other-

5 wise known by such person,

6 (e) Notice to Administrator of Unreasonable

7 Risks, — Any person who manufactures, processes, or dis-

8 tributes in commerce a chemical substance or mixture and

9 who obtains information which reasonably supports the con-

10 elusion that such substance or mixture causes or significantly

11 contributes to a substantial risk to health or the environment

12 shall immediately inform the Administrator of such infor-

13 mation unless such person has actual knowledge that the
1^ Administrator has been adequately informed of such in-
1^ formation,

(f) Definitions. — For purposes of this section, the
^'^ terms ^^manufacture'' and process" mean manufacture or
process for commercial purposes,

19 RELATIONSHIP TO OTHER FEDERAL LAWS

20 Sec, 9, (a) Laws Not Administered by the Ad-

21 MINISTRATOR. — (1) If the Administrator has reason to be-
2^ lieve that the manufacture, processing, distribution in com-

merce, v^e, or disposal of a chemical substance or mixture or
^ any combination of such actions causes or significantly con-
tributes to or is likely to cause or significantly contribute to

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166

1 an unreasonable risk to health or the environment and deter-

2 mines that such risk may be prevented or reduced to a suffi-

3 dent extent by action taken under a Federal law not adminis-

4 tered by the Administrator, the Administrator shall submit to

5 the agency which administers such law a report which de-

6 scribes such risk and includes in such description a specifica-

7 tion of the activity or combination of activities which the.

8 Administrator has reason to believe so causes or contributes

9 to such risk. Such report shall also request such agency —

10 (A)(i) to determine if the risk described in such

11 report may be prevented or reduced to a sufficient extent

12 by action taken under such law, and

13 (ii) if the agency determines that such risk may be

14 so prevented or reduced, to issue an order declaring

15 whether or not the activity or combination of activities

16 specified in the description of such risk causes or signifi-

17 canity contributes to such risk; and

18 (B) to report such determination and order to the

19 Administrator,

20 Any report of the Administrator shall include a detailed

21 statement of the information on which it is based and shall

22 be published in the Federal Register. The agency receiving

23 a request under such a report shall make the requested de-

24 termination, issue the requested order, and make the re-

25 quested report within such time as the Administrator specifies

79-313 0 - 77 - 24

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167

1 in the request, but such time specified may not be less than

2 ninety days from the date the request was made. The report

3 of an agency in response to a request of the Administrator

4 shall be accompanied by a detailed statement of the findings

5 and conclusions of the agency respecting the order and de-

6 termination requested to be made and shall be published in

7 the Federal Register,

8 (2) If the Administrator makes a report under para-

9 graph (1) with respect to a chemical substance or mixture

10 and the agency to which such report was made either —

11 (A) issues an order declaring that the activity or

12 combination of activities specified in the description of the

13 risk described in the report does not cause or significantly

14 contribute to the risk described in the report, or

15 (B) initiates, within ninety days of the publication

16 in the Federal Register of the report of the agenxiy under

17 paragraph (1) in response to the Administrator's report,

18 action under the law (or laws) administered by such

19 agency to protect against such risk,

20 the Administrator may not take any action under section 6

21 or 7 with respect to such risk.

22 (S) If the Administrator has initiated action under sec-

23 Hon 6 or 7 with respect to a risk associated with a chemical

24 substance or mixture which was the subject of a report made

25 to an agency under paragraph (1), such agency shall before

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168

1 taking action under the law (or laws) administered by it to

2 protect against such risk consult with the Administrator for

3 the purpose of avoiding duplication of Federal action against

4 such risk.

5 (h) Laws Administered by the Administrator,—

6 The Administrator shall coordinate actions taken under this

7 Act with actions taken under other Federal laws administered

8 in whole or in part by the Administrator. If a risk to health

9 or the environment associated with a chemical substance or

10 mixture could be eliminated or reduced to a sufficient extent

11 by actions taken under the authorities contained in such other

12 Federal laws, the Administrator shall use such authorities to

13 protect against such risk unless the Administrator determines

14 that it is in the public interest to protect against such risk by

15 actions taken under this Act. This subsection shall not be

16 construed to relieve the Administrator of any requirement

17 imposed on the Administrator by such other Federal laws.

18 (c) Occupational Safety and Health.— In exer-

19 dsing any authority under this Act, the Administrator shall

20 noty for purposes of section 4(b)(1) of the Occupational

21 Safety and Health Act of 1970, be deemed to be exercising

22 statutory authority to prescribe or enforce standards or regu-

23 lations affecting occupational safety and health.

24 (d) Coordination. — In administering this Act, the

25 Administrator shall consult and coordinate with the Secre-

364
169

1 tary of Health, Education, and Welfare and the heads of

2 any other appropriate Federal executive department or

3 agency, any relevant independent regulatory agency, and

4 any other appropriate instrumentality of the Federal Gov-

5 ernment for the purpose of achieving the maximum enforce-

6 ment of this Act while imposing the least burdens of dupli-

7 cative requirements on those subject to the Act and for other

8 purposes. The Administrator shall report annually to the

9 Congress on actions taken to coordinate with such other Fed-

10 eral departments, agencies, or instrumentalities, and on

11 actions taken to coordinate the authority under this Act with

12 the authority granted under other Acts referred to in sub-

13 section (b).

14 RESEARCH, COLLECTION, DISSEMINATION, AND

15 UTILIZATION OF DATA

16 Sec. 10. (a) Authority. — The Administrator shall, in

17 consultation and cooperation with the Secretary of Health,

18 Education, and Welfare and with other heads of appropriate

19 departments and agencies, conduct such research and moni-

20 toring as is necessary to carry out the purposes of this Act.

21 The Administrator may enter into contracts and may make

22 grants for such research and monitoring. Contracts may be

23 entered into under this subsection without regard to sections

24 3648 and 8709 of the Revised Statutes (31 U.S.C. 529, 41

25 U.S.C.5).

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1 (b) Data Systems.— (1) The Administrator shall

2 establish, administer, and be responsible for the continuing

3 activities of an interagency committee which will design,

4 establish, and coordinate an efficient and effective system,

5 within the Environmental Protection Agency, for the collec-

6 tion, dissemination to other Federal departments and agen-

7 cies, and use of data submitted to the Administrator under this

8 Act.

9 (2) (A) The Administrator shall, in consultation with

10 the Secretary of Health, Education, and Welfare and other

11 heads of appropriate departments and agencies design, estab-

12 lish, and coordinate an efficient and effective system for the

13 retrieval of toxicological and other scientific data which could

be useful to the Administrator in carrying out the purposes

of this Act. Systematized retrieval shall be developed for use

by all Federal and other departments and agencies with re-
17 ... .

sponsibilities in the area of regulation or study of chemical

substances and mixtures and their effect on health or the
environment.

(B) The Administrator, in consultation with the Secre-

tary of Health, Education, and Welfare, is authorized to

make grants and enter into contracts for the development of

a data retrieval system described in subpargaraph (A). Con-

tracts may be entered into under this subparagraph without

regard to sections 3648 and 3709 of the Revised Statutes
(31 U.S.C. 529, 41 U.S.C. 5).

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171

1 INSPECTIONS

2 Sec. 11. (a) In General. — For purposes of enforce-

3 ment of this Act the Administrator, or any representative of

4 the Administrator, duly designated by the Administrator, may

5 inspect any establishment, facility, or other premises in which

6 chemical substances or mixtures are manufactured, processed,

7 stored, or held before or after their distribution in commerce

8 and any conveyance being used to transport chemical sub-

9 stances or mixtures in connection with distribution in com-

10 merce. Such an inspection may only be made upon presenting

11 appropriate credentials and a written notice to the owner,

12 operator, or agent in charge of the premises or conveyance
1^ to be inspected. A separate notice shall be given for each such
1^ inspection, but a notice shall not be required for each entry
1^' made during the period covered by the inspection. Each

such inspection shall be commenced and completed with rea-
sonable promptness and shall be conducted at reasonable times,
within reasonable limits, and in a reasonable manner.
1^ (b) Scope. — ( 1 ) Except as provided in paragraph ( 2) ,

20 an inspection under subsection (a) shall extend to all things

21 within the premises or conveyance inspected (including rec-

22 ords, files, papers, processes, controls, and facilities) bearing
on whether the requirements of this Act applicable to the

^ chemical substances or mixtures within such premises or con-
veyance have been complied with.

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172

1 (2) No inspection under subsection (a) shall extend to —

2 (A) financial data,

3 (B) sales data other than shipment data,

4 (C) pricing data,

5 (D) personnel data, or

6 (E) research data (other than research data re-

7 quired by this Act) ,

8 unless the nature and extent of such data are described with

9 reasonable specificity in the written notice required by sub-

10 section ( a) for such inspection.

11 EXPORTS

12 Sec, 12. (a) General. — (1) Except as provided in

13 paragraph (2) and subsection (b), this Act (other than
1^ section 8) shall not apply to any chemical substance, mix-

ture, or an article containing a chemical substance or mix-
16 ture if—

■^'^ (A) it can be shown that such substance, mixture,

or article is being manufactured, processed, sold, or held
1^ for sale, for export from the United States, unless such

20 substance, mixture, or article was, in fact, manufactured,

21 processed, or distributed in commerce, for use in the
United States, and

(B) such substance, mixture, or article when dis-
^ tributed in commerce, or any container in which it is en-
^ closed when so distributed, bears a stamp or label stating

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173

1 that such substance, mixture^ or article is intended for

2 export.

3 (2) Paragraph (1) shall not apply to any chemical sub-

4 stance, mixture, or article if the Administrator finds that the

5 substance, mixture, or article will cause or significantly con-

6 tribute to an unreasonable risk to health within the United

7 States or to the environment of the United States. The

8 Administrator may require, under section 4, testing of a

9 chemical substance or mixture exempted from this Act by
1^ paragraph (1) to determine whether or not such substance

11 or mixture causes or significantly contributes to an unreason-

12 able risk to health within the United States or to the environ-
1^ ment of the United States.

(b) Notice. — (1) If any person exports or intends
to export to a foreign country a chemical substance or mixture
for which the submission of data is required under section 4
or 5(d), such person shall notify the Administrator of such
exportation or intent to export and the Administrator shall
1^ furnish to the government of such country notice of the avail-
2^ ability of the data submitted to the Administrator under such
section for such substance or mixture.
' (2) If any person exports or intends to export to a for-
eign country a chemical substance or mixture for which a rule
^ hm been proposed or promulgated under section 5 or 6, or
with respect to which an action is pending, or relief has been

369

174

1 granted under section 7, such person shall notify the Ad-

2 ministrator of such exportation or intent to export and the

3 Administrator shall furnish to the government of such country

4 notice of such rule, action, or relief.

5 ENTRY INTO CUSTOMS TERRITORY OF THE UNITED

6 STATES

7 Sec. 13. (a) In General.— (1) The Secretary of the

8 Treasury shall refuse entry into the customs territory of the

9 U nited States ( as defined in general headnote 2 to the Tariff

10 Schedules of the United States) of any chemical substance,

11 mixture, or article containing a chemical substance or mix-

12 ture offered for entry if —

13 (A) it fails to comply with any rule in effect under

14 this Act, or

15 (B) it is offered for entry in violation of section 5,

16 a rule or order under section 5 or 6, or an order issued
1*^ in an action brought under section 5 or 7.

18 (2) If a chemical substance, mixture, or article is

19 refused entry under paragraph (1), the Secretary of the

20 Treasury shall notify the consignee of such entry refusal,

21 shall not release it to the consignee, and shall cause its

22 disposal or, storage (under such rules as the Secre-

23 tary of the Treasury may prescribe) if it has not been ex-

24 ported by the consignee within ninety days from the date of

25 receipt of notice of such refusal, except that the Secre-

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175

1 tary of the Treasury may, pending a review by the Admin-

2 istrator of the entry refusal, release to the consignee such

3 substance, mixture, or article on execution of bond for the

4 amount of the full invoice of such siLbsiance, mixture, or

5 article ( as such value is set forth in the customs entry ) ,

6 together with the duty thereon. On failure to return such

7 substance, mixture, or article for any cause to the custody

8 of the Secretary of the Treasury when demanded, such

9 consignee shall be liable to the United States for liquidated

10 damages equal to the full amount of such bond. All charges

11 for storage, cartage, and labor on substances, mixtures, or

12 articles which are refused entry or release under this sec-

13 tion shall be paid by the owner or consignee, and in de-

14 fault of such payment shall constitute a lien against any

15 future entry made by such owner or consignee.

1^ (b) Rules. — The Secretary of the Treasury, after

17 consultation with the Administrator, shall issue rules for

18 the enforcement of subsection (a) of this section.

19 DISCLOSURE OF DATA

20 Sec. 14. (a) In General. — Except as provided by

21 subsection (b), any information reported to, or otherwise

22 obtained by, the Administrator (or any representative of

23 the Administrator) under this Act, which is exempt from

24 disclosure pursuant to subsection (a) of section 552 of

25 title 5, United States Code, by reason of subsection (b)

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176

1 (4) of such section, shall not be disclosed by the Admin-

2 istrator or by any officer or employee of the United States,

3 except that such information may be disclosed —

4 (1) to officers and employees of the United States —

5 (A) in connection with their official duties un-

6 der laws for the protection of health or the environ-

7 ment, or

8 (B) for specific law enforcement purposes;

9 (2) to contractors with the United States and

10 employees of such contractors if in the opinion of the

11 Administrator such disclosure is necessary for the satis-

12 factory performance by the contractor of a contract
1^ with the United States entered into on or after the

effective date of this Act for the performance of work
in connection with this Act; or

(3) when relevant in any proceeding under this

Act, except that disclosure in such a proceeding shall

1ft

be made in such manner as to preserve confidentiality

(b) Data From Health and Safety Studies.—
(1) Subsection (a) does not prohibit the disclosure of —

(A) any health and safety study submitted under
this Act with respect to —

(i) any chemical substance or mixture which

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177

1 on the date the study is to be disclosed has been

2 offered for commercial distribution, or

3 (ii) any chemical substance or mixture for

4 which testing is required under section 4 or for

5 which notification is required under section 5, and

6 (B) any data reported to, or otherwise obtained
^ by the Administrator from a health and safety study
8 which relates to a chemical substance or mixture de-
^ scribed in clause ( i) or (ii) of subparagraph (A).

This paragraph does not authorize the release of data which
discloses processes used in the manufacturing or processing
•^^ of a chemical substance or mixture or, in the case of a mix-
ture, the release of data disclosing the portion of the mixture
comprised by any of the chemical substances in the mixture.

(2) If a request is made to the Administrator under sub-
section (a) of section 552 of title 5, United States Code, for

information which is described in the first sentence of para-

graph (1) and which is not information described in the
second sentence of such paragraph, the Administrator may
not deny such request on the basis of subsection (b)(3) or

(b)(4) of such section.

putes. — (1) In submitting data under this Act, a person

may (A) designate the data which the person believes is
entitled to confidential treatment under subsection (a), and

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1 (B) submit such designated data separately from other data

2 submitted under this Act.

3 (2) If the Administrator proposes to release for inspec-

4 tion data which has been designated under paragraph (1)

5 (A), the Administrator shall notify, in writing and by certi-

6 fied mail, the person who submitted such data of the intent

7 to release such data. If the release of such data is to be made

8 pursuant to a request made under section 552 ( a) of title 5,

9 United States Code, such notice shall be given immediately

10 upon approval of such request by the Administrator. The

11 Administrator may not release such data until the expira-

12 tion of thirty days after the person submitting such data has

13 received the notice required by this paragraph.

14 (d) Criminal Penalty for Wrongful Disclo-
1^ SURE. — (1) Any officer or employee of the United States
1^ or former officer or employee of the United States, who by
-^-'^ virtue of such employment or official position has obtained
1^ possession of, or has access to, material the disclosure of which
19 prohibited by subsection (a), and who knowing that dis-

closure of such material is prohibited by such subsection, will-

^1 fully discloses the material in any manner to any person not

^ entitled to receive it, shall be guilty of a misdemeanor and

fined not more than $5,000 or imprisoned for not more than

^ one year, or both. Section 1905 of title 18, United States

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179

1 Code, does not apply with respect to the publishing, divulging,

2 disclosure, or making known of, or making available, infor-

3 mation reported or otherwise obtained under this Act.

4 (2) For the purposes of paragraph (1), any contractor

5 with the United States who is furnished information as

6 authorized by subsection (a)(2), and any employee of any

7 such contractor, shall be considered to be an employee of the

8 United States.

9 (e) Access by Congress. — Notwithstanding any

10 limitation contained in this section or any other provision of

11 law, all information reported to or otherwise obtained by the

12 Administrator (or any representative of the Administrator)

13 under this Act shall be made available, upon written request
1^ of any duly authorized committee of the Congress, to such
1^ committee.

1^ PROHIBITED ACTS

■^'^ Sec. 15. It shall be unlawful for any person to —

1^ (1) fail or refuse to comply with (A) any rule or

1^ order promulgated or issued under section 4, (B) any

20 requirement prescribed by section 5, or (C) any rule

21 order promulgated under section 5 or 6;

22 (2) use for commercial purposes a chemical sub-
^ stance or mixture which such person knew or had reason
24 to know was manufactured, processed, or distributed in

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1 commerce in violation of section 5, a rule or order

2 under section 5 or 6, or an order issued in an action

3 brought under section 5 or 7;

4 (3) fail or refuse to (A) establish or maintain rec-

5 ords, (B) submit reports, notices, or other information,

6 or (C) permit access to or copying of records^ as re-

7 quired by this Act or a rule thereunder; or

8 (4) fail or refuse to permit entry or inspection as

9 required by section 11 .

10 PENALTIES

11 Sec. 16. (a) Civil. — (1) Any person who violates

12 a provision of section 15 of this Act shall be liable to the

13 United States for a civil penalty in an amount not to exceed
^' $25,000 for each such violation. Each day such a violation

continues shall for purposes of this subsection constitute a
separate violation of section 15.

tion 554 of title 5, United States Code. Before issuing such

22 • • L

an order, the Administrator shall give written notice to the

Administrator s proposal to issue such order and provide

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181

1 such person an opportunity to request, within fifteen days of

2 the date the notice is received by such person, such a

3 hearing on the order.

4 (B) In determining the amount of a civil penalty, the

5 Administrator shall take into account the nature, drcum-

6 stances, extent, and gravity of the violation or violations
'7 and, with respect to the violator, ability to pay, effect on

8 ability to continue to do business, any history of prior such

9 violations, the degree of culpability, and such other matters
1^ as justice may require.

(C) The Administrator may, in the Administrator s
-^^ discretion, compromise, modify, or remit, with or without
1^ conditions, any civil penalty which may be imposed under
this subsection. The amount of such penalty, when finally
determined, or the amount agreed upon in compromise, may
be deducted from any sums owing by the United States to

the person charged.

(3) Any person who requested in accordance with
paragraph (2) (A) a hearing respecting the assessment of a
civil penalty and who is aggrieved by an order assessing a
civil penalty may file a petition for judicial review of such
order with the United States Court of Appeals for the
District of Columbia Circuit or for any other circuit in
^ which such person resides or transacts business. Such a

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182

1 petition may only be filed within the thirty-day period be-

2 ginning on the date the order making such assessment was

3 issued.

4 ('^) If any person fails to pay an assessment of a civil

5 penalty after it has become a final order and does not file

6 a petition for judicial review of the order in accordance

7 with paragraph (3) or after a court in an action brought

8 under paragraph (3) has entered final judgment in favor

9 of the Administrator, the Attorney General shall recover the

10 amount assessed (plus interest at currently prevailing rates

11 from such date) in an action brought in any appropriate

12 district court of the United States. In such an action, the

13 validity, amount, and appropriateness of such penalty shall

14 not be subject to review.

15 (b) Criminal. — Any person who knowingly or will-

16 fully violates any provision of section 15 shall, in addition

17 to or in lieu of a civil penalty which may be imposed under

18 subsection (a) of this section for such violation, be subject,

19 upon conviction, to a fine of not more than $25,000 for each

20 day of violation, or to imprisonment for not more than one

21 year, or both.

22 (c) Notice, Repurchase, or Replacement,— If in

23 a proceeding for the issuance of an order under paragraph

24 (1) to assess a civil penalty against a person the Adminis-

25 trator determines that such person manufactured, processed,

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183

1 or distributed in commerce a chemical substance or mixture

2 in violation of a requirement applicable to such substance or

3 mixture under paragraph (1) or (2) of section 6(a) or

4 otherwise determines by order made on the record after op-

5 portunity for agency hearing that a person has so violated

6 such a requirement, the Administrator may, in such order,

7 require such person (1) to give notice of the risk associated

8 with the chemical substance or mixture subject to such require-

9 ment to processors or distributors in commerce of such sub-

10 stance or mixture, or to both, and, to the extent reasonably

11 acertainable, to any other person in possession of or exposed

12 to such substance or mixture; (2) to give public notice of

13 such risk; (3) to either replace or repurchase such substance
or mixture, as determined by the person (or persons) to
whom the requirement is directed, in the manner prescribed
by the Administrator; or (4) to take any combination of the
actions described in the preceding clauses.

SPECIFIC ENFORCEMENT AND SEIZURE

1^ Sec, 17. (a) Specific Enforcement.— (1) The

district courts of the United States shall have jurisdiction

over civil actions to —
^ (A) restrain any violation of section 15,

(B) restrain any person from manufacturing or
^ processing a chemical substance before the expiration

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184

1 of the 'period before which such manufacturing or proc-

2 essing is prohibited under section 5,

3 (C) restrain any person from taking any action

4 prohibited by section 5 or by a rule or order under sec-

5 tion 5 or 6, or

6 (D) compel the taking of any action required by

7 or under this Act .

8 (2) A civil action described in paragraph (1) may be

9 brought —

10 (A) in the case of a civil action described in sub-

11 paragraph (A) of such paragraph, in the United States

12 district court for the judicial district wherein any act,

13 omission, or transaction constituting a violation of sec-
tion 15 occurred or wherein the defendant is found or

transacts business, or

(B) in the case of any other civil action described

in such paragraph, in the United States district court

for the judicial district wherein the defendant is found
or transacts business.

may be found. Subpenas requiring attendance of witnesses
in any such action may run into any judicial district.

(b) Seizure, — Any chemical substance or mixture

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185

1 which was manufactured, processed, or distributed in com-

2 merce in violation of this Act or any rule or order promul-

3 gated under this Act or any article containing such a sub-

4 stance or mixture shall be liable to be proceeded against, by

5 process of libel for the seizure and condemnation of such sub-

6 stance, mixture, or article, in any district court of the United

7 States within the jurisdiction of which such substance, mix-

8 ture, or article is found. Such proceedings shall conform as

9 nearly as possible to proceedings in rem in admiralty.

10 PREEMPTION

11 Sec. 18. (a) Effect on State Law.—(1) Except

12 as provided in paragraph (2), nothing in this Act shall

13 affect the authority of any State or political subdivision of
a State to establish or continue in effect regulation of any
chemical substance, mixture, or article containing a chemi-

cal substance or mixture.

(2) Except as provided in subsection (b) —

(A) if the Administrator requires by a rule pro-
mulgated under section 4 the testing of a chemical sub-
stance or mixture, no State or political subdivision may,
after the effective date of such rule, establish or con-
tinue in effect a requirement for the testing of such
substance or mixture for purposes similar to those for
^ which testing is required under such rule; and

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186

1 (B) if the Administrator prescribes a rule or

2 order under section 5 or 6 of this Act (other than

3 a rule imposing a requirement described in subsection

4 (a)(5) of section 6) which is applicable to a chemical

5 substance or mixture, and which is designed to protect

6 against a risk to health or the environment associated

7 with such substance or mixture, no State or political

8 subdivision of a State may, after the effective date of

9 8uch requirement, establish or continue in effect a re-

10 quirement applicable to such substance or mixture, or

11 an article containing such substance or mixture, and

12 designed to protect against such risk unless such require-

13 ment is identical to the requirement prescribed by the

14 Administrator or unless such requirement is adopted
1'^ under the authority of the Clean Air Act or any other
1^ Federal law.

1'^ (b) Exemption. — Upon application of a State or
political subdivision of a State the Administrator may by

19 rule exempt from subsection (a)(2), under such conditions

20 as may be prescribed in su6h rule, a requirement of such

21 State or political subdivision designed to protect against a

22 risk to health or the environment associated with a chemical
2^ substance, mixture, or article containing a chemical substance
^ or mixture if —

25 (±) compliance with the requirement would not

382
187

1 cause the manufacturing, processing, distribution in com-

2 merce, or use of the substance, mixture, or article to be in

3 violation of the applicable requirement under this Act

4 described in subsection (a) (2), and

5 (2) the State or political subdivision requirement

6 (A) provides a significantly higher degree of protec-

7 tion from such risk than the requirement under this Act

8 described in subsection (a)(2) and (B) does not,

9 through difficulties in marketing, distribution, or other

10 factors, unduly burden interstate commerce.

11 JUDICIAL REVIEW

12 Sec. 19. ( a) In General.— Not later than sixty days

13 following the promulgation of a rule under section 4, 5, or

14 6(a) of this Act, any person may file a petition for judicial
1^ review of such rule with the United States Court of Appeals
1^ for the District of Columbia Circuit or for the circuit in
1'^ which such person resides or in which such person's principal
1^ place of business is located. Copies of the petition shall

19 be forthwith transmitted by the clerk of such court to the

20 Administrator and to the Attorney General. The Adminis-

21 trator shall transmit to the Attorney General, who shall

22 file in the court, the record of the proceedings on which

23 the Administrator based such rule as provided in section
2^ 2112 of title 28, United States Code. For purposes of this

section, the term "record'' means such rule; any transcript

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188

1 required of any oral presentation; any written submission

2 of interested parties; and any other information which the

3 Administrator considers to he relevant to such rule and

4 with respect to which the Administrator, on or before the

5 date of the promulgation of such rule, published a notice in

6 the Federal Register identifying such information.

7 (b) Additional Data. — If the petitioner applies to

8 the court for leave to adduce additional data, views, or

9 arguments, and shows to the satisfaction of the court that

10 such additional data, views, or arguments are material and

11 that there are reasonable grounds for the petitioner's failure

12 io adduce such data, views, or arguments in the proceeding
1^ before the Administrator, the court may order the Adminis-

trator to provide additional opportunity for oral presentation
of data, views, or arguments and for written submissions.
The Administrator may modify findings or determinations
upon which the rule subject to review by such court was
based, or make new findings or determinations by reason of
the additional data, views, or arguments so taken and shall
2^ file such modified or new findings or determinations, and the
'^^ Administrator's recommendation, if any, for the modifica-
tion or setting aside of such rule, with the return of such
additional data, views, or arguments.
^ (c) Authority and Review Standard,— (1)
Upon the filing of a petition under subsection (a), the court

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189

1 shall have jurisdiction (A) to review the rule involved, in

2 accordance with chapter 7 of title 5, United States Code, and

3 (B) to grant appropriate relief, including interim relief, as

4 provided in such chapter. Any rule promulgated by the Ad-

5 ministrator under section 4, 5, or 6 of this Act and reviewed

6 under this section shall he affirmed, unless the determination

7 or findings required to he made hy the Administrator under

8 the applicable section are not supported by substantial evi-

9 dence on the record taken as a whole.

10 (2) The judgment of the court affirming or setting aside,

11 in whole or in part, any rule reviewed in accordance with

12 this section shall be final, subject to review hy the Supreme
1^ Court of the United States upon certiorari or certification, as
1^ provided in section 1254 of title 28, United States Code.
1^ (8) The judgment of the court in an action brought

pursuant to subsection (a) may include an award of costs

^'^ of suit and reasonable fees for attorneys and expert witnesses
if the court determines that such an award is appropriate,

19 The Supreme Court of the United States in its decision on a

20 review of a judgment in such an action may provide for the

21 award of costs of suit and reasonable fees for attorneys if the

22 court determines that su^h an award is appropriate.

23 ( d) Other Remedies, — The remedies provided in this

24 section- shall be in addition to and not in lieu of any other

25 remedies provided by law, .

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190

1 citizens' civil actions

2 Sec. 20. ( a) In General.— Except as provided in

3 subsection (b), any person may commence a civil action —

4 (1) against any person (including (A) the United

5 States, and (B) any other governmental instrumentality

6 or agency to the extent permitted by the eleventh

7 amendment to the Constitution) who is alleged to be

8 in violation of this Act or any rule prescribed under

9 section 4, 5, or 6(a) to restrain such violation, or

10 (2) against the Administrator to compel the Ad-

11 ministrator to perform any act or duty under this Act

12 which is not discretionary.

13 Any civil action under paragraph (1) shall be brought in the

14 United States district court for the district in which the
alleged violation occurred or in which the defendant resides

1^ or in which the defendant's principal place of business is lo-

1'^ cated. Any action brought tinder paragraph (2) shall be
brought in the United States District Court for the District of

19 Columbia, or the United States district court for the judicial

20 district in which the plaintiff is domiciled. The district courts

21 shall have jurisdiction over suits brought under this section,

22 without regard to the amount in controversy or the citizen-

23 ship of the parties. In any civil action under this subsection

24 process may be served on a defendant in any judicial district

386

191

1 in which the defendant resides or may be found and subpenas

2 for witnesses may run into any judicial district.

3 (b) Limitation,— No civil action may be com-

4 menced —

5 (1) under subsection (a)(1) to restrain a viola-

6 tion of this Act or rule under this Act —

7 (A) before the expiration of sixty days after

8 the plaintiff has given notice of such violation (i) to

9 the Administrator, and (ii) to the person who is

10 alleged to have committed such violation, or

11 (B) if the Administrator (or the Attorney

12 General on behalf of the Administrator) has com-
1^ menced and is diligently prosecuting a civil action

in a court of the United States to require compli-
ance with this Act or such rule, hut if such action
is commenced after the giving of notice, any person
giving such notice may intervene as a matter of

-to

right in such action; or

(2) under subsection (a)(2) before the expiration
of sixty days after the plaintiff has given notice to the
Administrator of the alleged failure of the Administrator
to perform an act or duty which is the basis for such
action or, in the case of an action under such subsection
^ for the failure of the Administrator to file an action

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192

1 under section 7, before the expiration of ten days after

2 such notificatian.

3 Notice under this subsection shall be given in such manner

4 as the Administrator shall prescribe by rule.

5 (c) General. — (1) In any action under this section,

6 the Administrator, if not a party, may intervene as a matter

7 of right.

8 (2) The court, in issuing any final order in any action

9 brough pursuant to subsection (a), may award costs of suit

10 and reasonable fees for attorneys and expert witnesses if the

11 court determines that such an award is appropriate. Any

12 court, in issuing its decision in an action brought to review

13 such an order, may award costs of suit and reasonable fees
for attorneys if the court determines that such an award is
appropriate.

(3) Nothing in this section shall restrict any right
which any person (or class of persons) may have under any
statute or common law to seek enforcement of this Act or
any rule under this Act or to seek any other relief.

(d) Consolidation. — When two or more civil actions
brought under subsection (a) involving the same defendant
and the same issues or violations are pending in two or
more judicial districts, such pending actions, upon applica^
^ tion of such defendants to such actions which is made to a

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193

1 court in which any such action is brought, may, if such

2 court in its discretion so decides, be consolidated for trial

3 by order (issued after giving all parties reasonable notice

4 and opportunity to be heard) of such court and tried in —

5 (1) any district which is selected by such defend-

6 ant and in which one of such actions is pending,

7 (2) a district which is agreed upon by stipulation

8 between all the parties to such actions and in which one

9 of such actions is pending, or

10 (3) a district which is selected by the court and

11 in which one of such actions is pending.

12 The court issuing such an order shall give prompt notification

13 of the order to the other courts in which the civil actions con-

14 solidated under the order are pending.

15 citizens' petitions

16 Sec. 21. (a) In General. — Any person may petition

1'^ the Administrator to initiate a proceeding for the issuance,

18 amendment, or repeal of a rule under section 4, 5(c), or

19 6(a).

20 (b) Procedures. — (1) Such petition shall be filed in

21 the principal office of the Administrator and shall set forth

22 the facts which it is claimed establish that it is necessary to

23 issue, amend, or repeal a rule under section 4, 5(c), or 6(a).

24 (2) The Administrator may hold a public hearing or

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194

1 may conduct such investigation or proceeding as the Admin-

2 istrator deems appropriate in order to determine whether or

3 not such petition should he granted.

4 (3) Within ninety days after filing of a petition de-

5 scribed in paragraph (1), the Administrator shall either

6 grant or deny the petition. If the Administrator grants such

7 petition, the Administrator shall promptly commence an ap-

8 propriate proceeding in accordance with section 4, 5(c), or

9 6(a). J f the Administrator denies such petition, the Adminis-

10 trator shall publish in the Federal Register the Administra-

11 tors reasons for such denial.

12 (4) (A) If the Administrator denies a petition filed

13 under this section (or if the Administrator fails to grant or

14 deny such petition within the ninety-day period) the peti-

15 tioner may commence a civil action in a United States dis-

16 trict court to compel the Administrator to initiate a rule-

17 making proceeding to take the action requested. Any such

18 action shall be filed vinthin sixty days after the Administra-

19 tors denial of the petition or, if the Administrator fails to

20 grant or deny the petition rvithin ninety days after filing

21 the petition, within sixty days after the expiration of the

22 ninety-day period.

23 (B) If in an action under subparagraph (A) respect-

24 ing a petition to initiate a proceeding to issue a rule under

25 section 4, 5(c), or 6(a) the petitioner demonstrates to the

390

195

1 satisfaction of the court, by a preponderance of the evidence

2 in a de novo proceeding before the court, that —

3 ( i) in the case of a petition to initiate a proceeding

4 for the issuance of a rule under section 4, that the manu-

5 facture, distribution in commerce, processing, use, or dis-

6 posal of the chemical substance or mixture to be subject

7 to such rule may cause or significantly contribute to an

8 unreasonable risk to health or the environment,

9 ( a) in the case of a petition to initiate a proceeding

10 for the issuance of a rule under section 5(c), that the

11 manufacture, processing, distribution in commerce, use,

12 or disposal of a chemical substance petitioned to be in-

13 eluded in a list compiled under such rule causes or sig-

14 nificantly contributes to or may cause or significantly

15 contribute to an unreasonable risk to health or the en-

16 vironment, or

17 (Hi) in the case of a petition for the issuance of a

18 rule under section 6(a), that there is a reasonable basis

19 to conclude that the manufacture, processing, distribution

20 in commerce, use, or disposal of a chemical substance

21 or mixture to be subject to such rule causes or signifi-

22 cantly contributes to or will cause or significantly con-

23 tribute to an unreasonable risk to health or the en-

24 vironment,

25 the court shall order the Administrator to initiate the action

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196

1 requested by the petitioner unless the court finds, after con-

2 sidering the extent of the risk to health or the environment

3 alleged by the petitioner in relation to the extent of risks to

4 health or the environment with respect to which the Admin-

5 istrator is taking action under this Act, the resources avail-

6 able to the Administrator to take the action requested by the

7 petitioner, and other relevant factors, the failure of the

8 Administrator to initiate such action was not unreasonable.

9 (C) The court in issuing any final order in any action

10 brought pursuant to subparagraph (A) may award costs of

11 suit and reasonable fees for attorneys and expert witnesses

12 if the court determines that such an award is appropriate.

13 Any court, in issuing its decision in an action brought to

14 review such an order, may award costs of suit and reason-
1*^ able fees for attorneys if the court determines that such an
1^ award is appropriate.

(5) The remedies under this section shall be in addi-

1^ tion to, and not in lieu of, other remedies provided by law.

1& NATIONAL DEFENSE WAIVER

20 Sec. 22. The Administrator shall waive compliance

21 with any provision of this Act upon a request and determi-
nation by the President that the requested waiver is neces-
sary in the interest of national defense. The Administrator
shall maintain a written record of the basis upon which such
waiver was granted and make such record available for in

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197

1 camera examination when relevant in a judicial proceeding

2 under this Act. Upon the issuance of such a waiver, the Ad-

3 ministrator shall publish in the Federal Register a notice

4 that the waiver was granted for national defense purposes,

5 unless, upon the request of the President, the Administrator

6 determines to omit such publication because the publication

7 itself would be contrary to the interests of national defense,
^ in which event the Administrator shall submit notice thereof
^ to the Armed Services Committees of the Senate and the

House of Representatives.

EMPLOYEE PROTECTION

Sec. 23. (a) In General. — No employer may dis-
charge any employee or otherwise discriminate against any
employee with respect to the employee's compensation, terms,
conditions, or privileges of employment because the employee
( or any person acting pursuant to a request of the employee )
has —

(1) commenced, caused to be commenced, or is
about to commence or cause to be commenced a pro-

ceeding under this Act;

(2) testified or is about to testify in any such pro-
ceeding; or

(3) assisted or participated or is about to assist or

^ participate in any manner in such a proceeding or in any
25

other action to carry out the purposes of this Act.

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198

1 (b) Remedy, — (1) Any employee who believes that

2 the employee has been discharged or otherwise discrimi-

3 nated against by any person in violation of subsection (a)

4 of this section may, within thirty days after such alleged

5 violation occurs, file (or have any person file on the em-

6 ployee's behalf) a complaint tvith the Secretary of Labor
'7 (hereinafter in this section referred to as the '^Secretary' )

8 alleging such discharge or discrimination. Upon receipt of

9 such a complaint, the Secretary shall notify the person named
10 in the complaint of the filing of the complaint.

(2)(^) Upon receipt of a complaint filed under para-
12 graph (1), the Secretaiy shall conduct an investigation of the
1^ violation alleged in the complaint. Within thirty days of the
receipt of such complaint, the Secretary shall complete such
inevstigation and shall notify in writing the complainant
(and any person acting on behalf of the complainant) and

the person alleged to have committed such violation of the

results of the investigation conducted pursuant to this para-
graph. Within ninety days of the receipt of such complaint the
Secretary shall, unless the proceeding on the complaint is

terminated by the Secretary on the basis of a settlement

entered into by the Secretary and the person alleged to have
23 .

committed such violation, issue an order either providing

the relief prescribed by subparagraph (B) or denying the
^ complaint. An order of the Secretary shall be made on the

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199

1 record after notice and opportunity for agency hearing. The

2 Secretary may not enter into a settlement terminating a

3 proceeding on a complaint without the participation and

4 consent of the complainant.

5 (B) If in response to a complaint filed under paragraph

6 (1) the Secretary determines that a violation of subsection

7 (a) of this section has occurred, the Secretary shall order (i)

8 the person who committed such violation to take affirmative

9 action to abate the violation, (ii) such person to reinstate
10 the complainant to the complainant^ s former position to-
ll gether with the compensation (including back pay), terms,

12 conditions, and privileges of the complainant's employment,

13 (Hi) compensatory damages, and (iv) where apprs>priate,

14 exemplary damages. If such an order is issued, the Secre-
1^ tary, at the request of the complainant, shall assess against
16 the person against whom the order is issued a sum equal to
1'^ the aggregate amount of all costs and expenses (including

18 attorney's fees) reasonably incurred, as determined by the

19 Secretary, by the complainant for, or in connection with, the

20 bringing of the complaint upon which the order was issued.

21 (c) Review. — (1) Any person adversely affected or

22 aggrieved by an order issued under subsection (b) may

23 obtain review of the order in the United States Court of

24 Appeals for the circuit in which the violation, with respect

25 to which the order- was issued, allegedly occurred. The peti-

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200

1 Hon for review must be filed within sixty days from the issu-

2 ance of the Secretary's order. Review shall conform to chap-

3 ter 7 of title 5 of the United States Code.

4 (2) An order of the Secretary, with respect to which

5 review could have been obtained under paragraph (1), shall

6 not be subject to judicial review in any criminal or other

7 civil proceeding.

8 (d) Enforcement.— (1) Whenever a person has

9 failed to comply with an order issued under subsection (b)

10 (2), the Secretary shall file a civil action in the United

11 States district court for the district in which the violation

12 was found to occur to enforce such order. In actions brought

13 under this subsection, the district courts shall have jurisdic-

14 tion to grant all appropriate relief, including injunctive relief

15 and compensatory and exemplary damages. Civil actions
1^ brought under this subsection shall be heard and decided

expeditiously.

IS (2) Any nondiscretionary duty imposed by this section

19 is enforceable in mandamus proceeding brought under section

20 1361 of title 28, United States Code.

21 (e) Exclusion. — Subsection (a) of this section shall

22 not apply with respect to amy employee who, acting with-

23 out direction from the employee's employer ( or any agent of

24 the employer), deliberately causes a violation of any require-

25 ment of this Act.

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201

1 EMPLOYMENT EFFECTS

2 Sec. 24. (a) In General.— The Administrator shall

3 evaluate on a continuing basis the potential effects on em-

4 ployment (including reductions in employment or loss of

5 employment from threatened plant closures) of —

6 (1) the issuance of a rule or order under section 4,

7 5, or 6, or

8 (2) a requirement of section 5.

9 (b)(1) Investigations. — Any employee (or any
representative of an employee) may request the Adminis-

11 trator to make an investigation of —

12 (A) a discharge or layoff or threatened discharge or

13 layoff of the employee, or «^

14 (B) adverse or threatened adverse effects on the

15 employee's employment,

16 allegedly resulting from a rule or order under section 4, 5,

17 or 6 or a requirement of section 5. Any such request shall be

18 made in writing, shall set forth with reasonable particularity

19 the grounds for the request, and shall be signed by the

20 employee, or representative of such employee, making the

21 request.

22 (2) (A) Upon receipt of a request made in accordance

23 with paragraph (1) the Administrator shall (i) conduct the

24 investigation requested, and (ii) if requested by any inter-

25 ested person, hold public hearings on any matter involved

397

1 in the investigation unless the Administrator determines that

2 there are no reasonable grounds for holding such hearings.

3 If the Administrator makes such a determination respecting

4 a request for a hearing, the Administrator shall notify in

5 writing the person requesting the hearing of the determination

6 and the reasons therefor.

7 (B) If public hearings are to he held on any matter

8 involved in an investigation conducted under this subsection —

9 (i) at least five days' notice shall be provided the

10 person making the request for the investigation and any

11 person identified in such request^

12 (ii) a transcript shall be made of the hearings, and

13 (Hi) each employee who made or for whom was
made a request for such hearings and the employer of
such employee shall be required to present information
respecting the applicable matter referred to in paragraph
(1)(A) or (1)(B) together with the basis for such
information.

(3) Upon completion of an investigation under para-
graph (2), the Administrator shall make findings of fact,
shall make such recommendations as the Administrator deems

appropriate, and shall make available to the public such find-

ings and recommendations.

( 4) In connection with any investigation or public hear-
ing conducted under this subsection, the Administrator may

398

203

1 issue subpenas for the attendance and testimony of witnesses

2 and the production of relevant papers, books, and documents,

3 and the Administrator may administer oaths. Witnesses

4 summoned shall be paid the same fees and mileage that are

5 paid witnesses in the courts of the United States. In case

6 of contumacy or refusal to obey a suhpena served upon any

7 person under this paragraph, the United States district

8 court for any district in which such person is found or

9 resides or transacts business, upon application by the United

10 States and after notice to such person, shall have jurisdic-

11 tion to issue an order requiring such person to appear and

12 give testimony before the Administrator to appear and pro-

13 duce papers, books, and documents before the Adminisk'ator,

14 or both, and any failure to obey such order of the court may
1^ be punished by such court as a contempt thereof.

1^ STUDIES

^'^ Sec. 25. (a) Indemnification Study. — The Admin-
istrator shall conduct a study of all Federal laws adminis-

19 tered by the Administrator for the purpose of determining

20 whether and under what conditions, if any, iyidemnification

21 should be accorded any person as a result of any action taken

22 by the Administrator under any such law. The study shall —

23 (^) include an estimate of the probable cost of any
^ indemnification programs which may be recommended;
^ (2) include an examination of all viable means of

399

204

1 financing the cost of any recommended indemnification;

2 and

3 (3) be completed and submitted to Congress not

4 less than two years from the effective date of this Act.

5 The General Accounting Office shall review the adequacy of

6 the study submitted to Congress pursuant to paragraph (3)

7 and shall report the results of its review to the Congress

8 within six months of the date such study is submitted to

9 Congress.

1^ (b) Classification, Storage, and Retrieval

1^ Study, — The Council on Environmental Qv/dity, in consul-

^2 tation with the Administrator, the Secretary of Health, Edu-

cation, and Welfare, the Secretary of Commerce, and the

■^^ heads of other appropriate Federal departments or agen-

cies, shall coordinate a study of the feasibility of establishing

(1) a standard classification system for chemical substances

■^'^ and related substances, and (2) a standard means for
18

storing and for obtaining rapid access to information re-
specting such substances. A report on such study shall be
completed and submitted to Congress not later than eighteen
months after the effective date of this Act.

administration of act

Sec, 26, (a) Cooperation of Federal Agencies,—
^ Upon request by the Administrator, each Federal depart-
meit and agency is authorized —

400

205

1 (1) to make its services, personnel, and facilities

2 available (with or without reimbursement) to the Ad-

3 ministrator to assist the Administrator in the admin-

4 istration of this Act; and

5 (2) to furnish to the Administrator such informa-

6 Hon, data, estimates, and statistics, and to allow the
'7 Administrator access to all information in its possession
^ as the Administrator may reasonably determine to be
^ necessary for the administration of this Act.

1^ (b) Fees. — The Administrator may, by rule, require
^1 the payment of a reasonable fee from any person required
to submit data under section 4 or 5 of this Act to defray
the cost of administering this Act. Such rules shafl not
provide for any fee in excess of $2,500. In setting such a fee,
the Administrator shall take into account the ability to pay
of the person required to submit the data and the cost to the
Administrator of reviewing such data. Such rules may pro-
vide for sharing such a fee in any case in which the expenses
of testing are shared under section 4 or 5 of this Act.
2^ (c) Action With Respect to Categories.— (1)
Any action authorized or required to be taken by the Ad-
ministrator under any provision of this Act with respect to a
chemical substance or mixture may be taken by the Admin-
istrator in accordance with that provision with respect to a
category of chemical substa/nces or mixtures. Whenever the

401

206

1 Administrator takes action under a provision of this Act with

2 respect to a category of chemical substances or mixtures, any

3 reference in this Act to a chemical svhstance or mixture

4 (insofar as it relates to such action) shall be deemed to be

5 a reference to each chemical substance or mixture in such

6 category,

7 (2) For purposes of paragraph (1) :

8 (A) The term "category of chemical substances^'

9 m£ans a group of chemical suhsta/nces the members of

10 which are similar in molecular structure, in physical,

11 chemical, or biological properties, in use, or in mode of

12 entrance into the human body or into the environment,

13 or the members of which are in some other way suitable

14 for classification as such for purposes of this Act, except

15 that such term does not mean a group of chemical sub-

16 stances which are grouped together solely on the boMS

17 of their being new chemical substances.

18 (B) The term '^category of mixtures" means a

19 group of mixtures the members of which are similar in

20 molecular structure, in physical, chemical, or biological

21 properties, in use, or in mode of entrance into the human

22 body or into the environment, or the members of which

23 are in some other way suitable for chissification as such

24 for purposes of this Act.

25 (d) Assistance Office.— The Administrator shall

402

207

1 establish in the Environmental Protection Agency an identi-

2 fiable office to provide technical and other nonfinancial assist-

3 ance to manufacturers and processors of chemical substances

4 and mixtures respecting the requirements of this Act appli-

5 cable to such manufacturers and processors, the policy of the

6 Agency respecting the application of such requirements to

7 such manufacturers and processors, and the means and

8 methods by which such manufacturers and processors may

9 comply with such requirements.

10 DEVELOPMENT AND EVALUATION OF TEST METHODS

11 Sec. 27. (a) The Secretary of Health, Education, and

12 Welfare, in consultation with the Administrator and acting

13 through the Assistant Secretary for Health, may conduct, and
make grants to public and nonprofit private entities and enter
into contracts with public and private entities for, projects for

-in

the development and evaluation of inexpensive and efficient
methods (1) for determining and evaluating the health and
environmental effects of chemical substances and mixtures, and
their toxicity, persistence, and other characteristics which
affect health and the environment, and (2) which may be used
for the development of test data to meet the requirements of
rules promulgated under section 4. The Administrator shall
consider such methods in prescribing under section 4 siand-

ards for the development of test data.

403

208

1 (b) No grant may be made or contract entered into

2 under subsection (a) unless an application therefor has

3 been submitted to and approved by the Secretary. Such an

4 application shall be submitted in such form and manner and

5 contain such information as the Secretai^ may require. The

6 Secretary may apply such conditions to grants and contracts
under subsection (a) as the Secretary determines are neces-

8 sary to carry out the purposes of such subsection. Contracts

9 may be entered into under such subsection without regard to

10 sections 3648 and 3709 of the Revised Statutes (31 U.S.C.

11 529;41U.S,C.5),

1^ (c)(1) The Secretary shall prepare and submit to the

1^ President and the Congress on or before January 1 of each
1- year a report of the number of grants made and contracts

entered into under this section and the results of such

grants and contracts.

(2) The Secretary shall periodically publish in the

Federal Register reports describing the progress and results

oj any co\

AUTHORIZATION FOR APPROPRIATIONS

of any contract entered into or grant made under this section.

Sec. 28. There are authorized to be appropriated to

the Administrator for purposes of carrying out this Act
(other than section 27 thereof) $11,100,000 for the fiscal
^ year ending September 30, 1978, $10,100,000 for the fiscal
^ year ending September 30, 1979, and $11,100,000 for the

404

209

1 fiscal year ending September 30 1980. No part of the funds

2 appropriated under this section may be used to construct any

3 research laboratories.

4 ANNUAL REPORT

5 Sec. 29. The Administrator shall prepare and submit to

6 the President and the Congress on or before January 1,

7 1979, and on or before January 1 of each succeeding year

8 a comprehensive report on the administration of this Act

9 during the preceding fiscal year. Such report shall include —

10 (1) a list of the testing required under section 4

11 during the year for which the report is made and an

12 estimate of the costs incurred during such year by the
1^ persons required to perform such tests;

(2) the number of notices received during such year
under section 5, the number of such notices received dur-

■^^ ing such year under such section for chemical substances
subject to a section 4 rule, and a summary of any action

■^^ taken during such year under section 5(g);

1^ (3) a list of rules issued during such year under

2^ section 6;

21 (4) a list,- with a brief statement of the issues, of

completed or pending judicial actions under this Act

during such year;
2^. (5) a summary of major problems encountered in

the administration of this Act; and

405

210

1 (6) such recommendations for additional legislation

2 as the Administrator deems necessary to carry out the

3 purposes of this Act.

4 EFECTIVE DATE

5 Sec. 30. This Act shall take effect October 1, 1977.

407

i^^on'' } HOUSE OF REPRESENTATIVES { no'^Si

, TOXIC SUBSTANCES CONTROL ACT

REPORT

BY THE

COMMITTEE ON INTERSTATE AND
FOREIGN COMMERCE
together with
SUPPLEMENTAL AND MINORITY VIEWS
(Including cost estimate of the Congressional Budget Office)
[To accompany H.R. 14032]

July 14, 1976.— Committed to the Committee of the Whole House
on the State of the Union and ordered to^be printed

U.S. GOVERNMENT PRINTING OFFICE
74-031 WASHINGTON : 1976

408

CONTENTS

Page

Purpose of the legislation.. 1

Brief summary 2

Basis for the legislation 3

Committee consideration 7

Cost of legislation 8

Section-by-section analysis 8

Program oversight 63

Inflationary impact statement 68

Congressional Budget OflBce cost estimate 64

Agency reports 65

Committee amendment 100

Supplemental views 135

Minority views 139

(in)

409

94th Congress ) HOUSE OF REPRESENTATIVES j Report
2d Session f ( No. 94-1341

TOXIC SUBSTANCES CONTROL ACT

July 14, 1976. — Ordered to be printed

Mr. Staggers, from the Committee on Interstate and Foreign
Commerce, submitted the following

REPORT

together with
SUPPLEMENTAL AND MINORITY VIEWS
(Including cost estimate of the Congressional Budget Office)
[To accompany H.R. 140^2 1

The Committee on Interstate and P^o reign Commerce, to whom was
referred the bill (H.R. 14032) to regulate commerce and protect
health and the environment by requiring testing and necessary restric-
tions on certain chemical substances and mixtures, and for other pur-
poses, having considered the same, report favorably thereon with an
amendment and recommend that the bill as amended do pass.

The amendment strikes out all after the enacting clause of the bill
and inserts a new text which appears in italic type in the reported
bill.

Purpose of the Legislation

The Committee bill takes a major step forward in providing urgently
needed authority to protect health and the environment from danger-
ous chemicals. It accomplishes this in a number of ways. For example,
through its testing and premarket notification provisions, the bill pro-
vides for the evaluation of the hazard-causing potential of new chem-
icals before commercial production begins. Thus, in addition to the
authority to take action against a chemically-caused harm after its oc-
currence, there will be authority to prevent such harm from occurring.
Further, manufacturers and processors of potentially hazardous chem-
icals already on the market may be required to test them to determine
their effects on health and the environment, and action can be taken
against chemicals disco veered to be unreasonably hazardous. In addi-
tion, the bill provides for the collection of information regarding
commercially produced chemicals so that the total exposure to a chemi-

(1)

79-313 0 - 77 - 27

410

cal and its total effect on health and the environment can be monitored
and evaluated.

Brief Summary

Briefly, the bill will—
— Require manufacturers and processors of potentially harmful
chemical substances and mixtures to test the substances or mix-
tures, as required by rules issued by the Administrator of the
Environmental Protection Agency, so that their effect on health
and the environment may be evaluated.

— Require manufacturers of new chemical substances and manu-
facturers and processors of existing chemical substances for sig-
nificant new uses to notify the Administrator ninety days in ad-
vance of commercial production.

— Authorize delays or restrictions on the manufacture of a new
chemical substance if there is inadequate information to evaluate
the health or environmental effects of the substance and if in the
absence of such information, the substance may cause or signifi-
cantly contribute to an unreasonable risk to health or the
environment.

— Authorize the Administrator to adopt rules to prohibit the
manufacture, processing, or distribution of a chemical substance
or mixture, to require labeling, or to regulate the manner of dis-
posal of a chemical substance or mixture for which there is a rea-
sonable basis to conclude that it causes or significantly 'contributes
to an unreasonable risk to health or environment.
— Authorize the Administrator to obtain injunctive relief from a
United States district court to protect the public and the environ-
ment from an imminently hazardous chemical substance or
mixture.

— Authorize the Administrator to require manufacturers and
processors to submit reports and maintain records respecting their
commercially produced chemical substances and mixtures, to
maintain records respecting adverse health or environmental
effects of such substances and mixtures, and to provide available
health and safety data on them.

— Require manufacturers and processors of chemical substances
and mixtures to immediately notify the Administrator of in-
formation indicating that one of their substances or mixtures
causes or contributes to a substantial risk to health or environ-
ment.

— Permit administrative inspections to enforce the bill and au-
thorize court actions for seizures of chemical substances and mix-
tures which have been manufactured or distributed in violation
of the requirements of the bill or of rules and orders promulgated
under it.

— Permit citizens to bring suits to obtain compliance with the
bill.'

— Permit Federal district courts to order the Administrator to
initiate rulemaking proceedings in response to citizen petitions.
— Set up procedural mechanisms to insure that all interested per-
sons have an opportunity to participate in the agency rulemaking
proceedings.

411

— Provide protection for employees who cooperate in the en-
forcement of the bill.

— Provide for evaluation on a continuing basis of the effects on
employment of actions taken under the bill.

Basis for the Legislation

Chemicals have become a pervasive and enduring part of our en-
vironment. They are in our air, our water, and our soil. They are used
in our manufacturing processes, and they are essential components for
consumer and industrial goods. Production and use of chemicals have
surged in the recent past. For example, in the past ten years, the pro-
duction of synthetic organic chemicals has expanded by 233 percent,^
and over 9,000 synthetic chemical compounds are each now in com-
mercial use annually in amounts in excess of 1,000 pounds each.- In
1973, production of the top 50 chemicals alone totaled 410 billion
pounds.^ Society reaps enormous benefits from chemicals. However, it
is generally accepted that as the number of chemicals in commercial use
is greatly increased, the risk of producing chemicals that can cause
grave and irreversible environmental damage or health problems is
also increased.

This vast volume of chemicals have, for the most part, been re-
leased into the environment with little or no knowledge of their long-
; term health or environmental effects. As a result, chemicals currently
! in commercial and household use are now being found to cause or
contribute to health or environmental hazards unknown at the time
commercial use of the chemical began. For example, vinyl chloride
was the 23rd most produced chemical when it was discovered to cause
cancer, and the chemical has now been implicated as causing birth de-
fects as well.* Asbestos, widely used in items ranging from talcum
powder to brake linings to wallboard, is now known to cause cancer
and other debilitating illnesses. However, such effects were not dis-
covered until hundreds of workers had developed a rare form of
lung cancer as a result of exposure to the substance.^ Polychlori-
nated biphenyls (PCBs) had been used for forty years and approxi-
mately 390,000 tons had been released into the environment before
they were i-ecognized as an enduring environmental poison.*^ Unfortu-
nately, such recognition came too late to prevent contamination of such
major water systems as the Great Lakes and the Hudson River.

As the preceding examples indicate, it is often many years after
exposure to a harmful chemical before the effects of its harm become
visible. By that time it may be too late to reverse those effects. As
indicated, hundreds of people may have been exposed to a carcinogen
or an entire river system may have been polluted.

The experience with chemicals over the past few years has con-
tributed to a growing realization that many of the major health prob-

^ Sixth Annual Report, Council on Environmental Policy, p. 23 (1975).
-Toxic Suhstances, Council on Environmental Quality, p. 3 (1975).

^Activities of Federal Agencies Concerning Selected High Volume Chemicals, U.S. Envi-
ronmental Protection Acency. EPA-560-4- 75-001, n. ii (1975K

* Infante, Peter F.. "Oncofrenic and Mutagenic Risks in Communities with Polj'vinyl
Chloride Product P'aciliries," 271 New York Academy of Science Annals, pp. 49-57 (1976).
Selicoff. I. J.. "Asbestos Criteria Document Higlilights," American Society of Safety
■ ^'"//."^er.s Journal, p. 26 (March, 1974),

, " "Effects of Chronic Exposure to Low-Level Pollutants in the Environment," Congres-
sional Research Service, p. 2 (1975).

412

lems are caused by environmental factors. For example, approxi-
mately 60 to 90 per cent of all cancer is believed to be environmentally
caused.^ The National Foundation for the March of Dimes estimates
that about 20% of all birth defects as caused by environmental in-
fluences, including chemicals, on the unborn child, and another 60% of
birth defects are believed to be due to a combination of environmental
and hereditary factors.^

Because diseases caused by environmental factors such as chemicals
are often not susceptible to direct medical cure, there is an urgent need
to prevent such chemically caused harm. The Department of Health,
Education, and Welfare's Forward Health Plan stresses such preven-
tion, stating :

In recent years, it has become clear that only by preventing
disease from occurring, rather than treating it late, can we
hope to achieve any major improvement in the nation's
health . . . [Heart disease, cancer, and stroke] are caused by
factors (e.g., the environment and individual behavior) that
are not susceptible to direct medical solution.

... It is therefore, a basic premise of the prevention
strategy that much greater attention and resources must be
directed at preventing the underlying causes of disease rather
than at the disease itself — at controlling cigarette smoking,
alcohol abuse, and exposures to toxic chemicals in the environ-
ment than at the diseases which they cause.^

Similarly, the environmental harm caused by chemicals, like health
effects, may be irreversible, and prevention of such harm is also
urgently needed.

Toxic Substances^ a 1971 report by the Council on Environmental
Quality, reviewed the problems presented by toxic chemicals and con-
cluded that present authorities for protecting against hazardous
chemicals are fragmented and inadequate. According to the report,
authority is needed to require testing of chemicals to determine their
health and environmental effects, to impose use and distribution re-
strictions on chemicals where necessary to protect the public health
and environment, and to collect information on chemicals and estab-
lish a system for classifying and using such information.

The recommendations of the report provided the original basis for
the toxic substances control legislation. However, subsequent events
have dramatically illustrated the urgent need for the legislation. For
example, a major epidemiological study by the National Cancer Insti-
tute indicates that industrial chemical use and activity have produced

1 "Sixth Annual Report," Council on Environmental Quality, p. 17 (1975). Chemicals
are not, of course, the only environmental factors linked to cancer. Others Include the large
component of lung cancer attributable to cigarette smoking and natural agents such as
solar radiation.

The costs to society from cancer are tremendous. The American Cancer Society esti-
mates that 25 percent .of the 213 million people now living in the United States will ulti-
mately d'evelon some 'form of cancer. "Cancer Facts and Figures." American Cancer
Society, p. 3 (1975). Cancer killed an estimated 364,000 Americans in 1975. Ihid.

The economic costs of cancer are staggering. An estimated $3 billion is spent annually
for hospital care, physician fees, nurses, drugs and other treatment. If the direct and in-
direct costs (e.g., loss of productivity, earning power) are added, the annual costs of
cancer lump to $15 billion. Id. at 31.

2 "Effects of Chronic Exposure to Low-Level Pollutants In the Environment, p. 135.

» "Forward Plan for Health." fiscal years 1977-81, U.S. Department of Health, Educa-
tion, and Welfare, Public Health Service, pp. 12, 13, 15, 16, 17 (June 1975).

413

striking geographic concentrations of cancer deaths.^ An unusually
high rate of lung cancer among workers in a plant where bis chloro-
methyl ether (BCME) was produced as a by-product of a manufactur-
ing proceSvS has led to the conclusion that BCME is a highly potent car-
cinogen. BCME may form spontaneously in ordinary humid air
whenever formaldehyde and hydrochloric acid are present together.
These two chemicals are widely used in processes such as the treat-
ment of permanent press fabrics, in the manufacture o.f water repel-
lants, and in the manufacture of ion exchange resin's and dispersing
agents. Further, tris 2, 3-dibromopropyl phosphate, a fire retardant
widely used in such items as children's pajamas, has been shown to
have mutagenic effects in microbial systems. And there are, unfortu-
nately, numerous other examples of harm resulting from the indus-
trial uses of chemicals.

Because of the lack of testing by manufacturers and processors of
chemicals to determine their health and environmental effects, the
general population and tlie environment now serve as the laboratory
for discovering adverse health and environmental effects. Aside from
the glaring inequities in relying on human experience to indicate
when a chemical is harmful, such a method is also a grossly inefficient
way to identify problems. P'or example, vinyl chloride and asbestos
were relatively e^isy hazards to identify because exposure to these
agents could be correlated with incidences of otherwise rare cancers
in a uniquely defined group of workers. Other kinds of hazards, and
other substances, cannot be expected to present such easily traceable
cause and effect relationships. As a result exposure to an extremely
harmful chemical may continue unabated because the harm it causes
will never be linked to the chemical.

Fortunately our ability to screen and test substances for ad-
verse effects and our capabilities for monitoring and predicting
the health and environmental effects of chemicals are sufficiently
well-developed that it is not necessary to choose between the alterna-
tives of using the population as guinea pigs or doing without the bene-
fits provided by the increasing use and development of chemical prod-
ucts. The validity of applying animal test results to man is now firmly
based upon empirical evidence and thus such results provide an invalu-
able tool for predicting human health effects. Further, major method-
ological advances are occurring with respect to improving testing and
monitoring methods for assessing the long-term effects of a chemical.
For example, methods for detecting low levels of carcinogens in the
environment have increased significantly in both accuracy and reli-
ability, and it is now possible to detect concentrations of polynuclear
compounds at 1 part of an indi\ddual compound per billion as opposed
to the 1959 sensitivity standard of 100 parts per billion. Analytical
methods have improved as well. Illustrative is the salmonella test de-
veloped by Dr. Bruce Ames of the University of California, Berkeley,
which is now available for screening for cancer-causing properties of
chemicals and which has considerably reduced both the costs and time
required for such screening. Although testing and monitoring may

^ Hearings on H.R. 7229. H.R. 7548. and H.R. 7664 before The Subcommittee on Con-
sumer Protection and Finance of the House Committee on Interstate and Foreign Com-
merce, 94th Cong., Ist Sess., p. 132-138 (1975).

414

not be able to provide certainty as to the long-term consequences
resulting from exposure to a chemical, the prSlictions from such
testing and monitoring can provide a reasonable basis for regula-
tory action to protect against potential long-term adverse effects.

Present authorities for protecting against and regulating hazardous
chemicals are fragmented and inadequate. Although there are a num-
ber of Federal laws which now provide some authority for regulation
(e.g., the Clean Air Act, the Federal Water Pollution Control Act, the
Occupational Safety and Health Act of 1970, and the Consumer Prod-
uct Safety Act) conspicuous gaps exist in the protections provided by
such laws. Most significant among the deficiencies are the following :

(1) In general, such laws provide regulatory authority which is
not set in motion until after human or environmental exposure to
a harmful chemical has occurred.

(2) The authorities provided to reduce or eliminate the harm-
ful exposure to a chemical may not be adequate or may be cum-
bersome or inefficient.

(3) No authority exists for collection of data to determine the
totality of human and environmental exposure to chemicals.

An example of the deficiency described in paragraph (1) is the fact
that there is presently no authority to require manufacturers of poten-
tially dangerous new chemicals to test the chemical to determine its
health and environmental effects before marketing. Thus, although
there is some authority to remove harmful chemicals from, the work-
place, the home, etc., there is no authority which provides a means
of assessing the safety of a chemical before exposure occurs. In-
addition, since present laws require regulatory agencies to bear the
cost of testing to see if a chemical is safe, regulatory action often
does not occur until adverse effects of a chemical become evident
in the population or in the environment.

The inadequacies in current authorities to deal with the recognized
harm presented by poly chlorinated biphenyls (PCBs) illustrates the
deficiencies in present law to deal with known harmful chemicals.
Under the Federal Water Pollution Control Act, the Administrator
of the Environmental Protection Agency has authority to control the
discharge of PCBs into the waters. However, there is no means for
regulating other avenues through which the environment is exposed
to PCBs. For example, an estimated three-fourths of the amount of
discarded PCB's have been disposed of in landfills. Under existing
law there is no authority to deal with such disposal and even though
water emissions may be restricted, environmental exposure through
seepage from landfills will continue to occur.

Intelligent standards for regulating exposures to a chemical in the
workplace, the home or elsewhere in the environment cannot be set
unless the full extent of human or environmental exposure is consid-
ered. The importance of considering the cumulative impact of all
sources of exposure and the synergistic effects resulting from exposure
to a number of chemicals in regulatins: hazardous chemicals was
pointed out by the National Academy of Sciences — National Academy
of Engineers study which stated :

The concept of total body burden should be the significant
indicator of exposure, rather than burden acquired in one or

415

another part of the environment or from one or another
toxic material. People who work in a factory in which dan-
gerous substances are handled in high concentration may
live in an adjacent area in which the same or other substances
are dispersed, thus increasing overall exposure. More than
one organ may be attacked because the offending substance
is transported by two or more media. Synergistic effects
among two or more substances, by which the combined effect
is more than the sum of the separate effects should be con-
sidered.^

Yet a comprehensive data system indicating the totality of human
or environmental exposure does not exist. As a result, present regula-
tions controlling workplace exposure, exposure in the home or else-
where to a hazardous chemical may often be based on measurements
indicating only one source of exposure, thereby resulting in less than
full prote<:tion from the hazard.

In summary, the country faces serious risks of harm to the health of
its people and to its environment from the substantial use which is
made of chemicals, and Federal law is clearly inadequate to deal with
such risks. A major element in our efforts to improve the nation's
health and environment must be the enactment of protective legisla-
tion such as H.R. 14032. The overriding purpose of the bill is to pro-
vide protection of health and the environment through authorities
which are designed to prevent harm.

Committee Consideration

A 1971 report by the Council on Environmental Quality highlighted
the growing need for a comprehensive program of toxic substances
control. Based upon the Council's recommendations, the Environ-
mental Protection Agency submitted legislative proposals on behalf
of the Administration to the 92d Congress. The Committee's Subcom-
mittee on Commerce and Finance held hearin.ors on the Administration
bill, and a Senate-passed bill which made substantial amendments to
the Administration bill. After executive session, the Subcommittee re-
ported a clean bill which represented an accommodation between the
Administration and Senate-passed bills. This bill with certain further
amendments was reported by the full Committee and passed the
House by a record vote of 240 to 61. Time did not permit a conference
with the Senate to work out differences before the adjournment of the
92d Congress.

In the 93d Congress, the Subcommittee on Commerce and Finance
held hearings on a new bill submitted by the Administration (H K.
5087) and a bill introduced bv the Subcommittee chairman, Mr. Moss,
and others (H.R. 5356) which substantially followed the bill passed
by the House in the 92d Congress. The Subcommittee reported H.R.
5356, with amendments. The bill with certain further amendments was
reported by the full Committee and passed the House by a record vote
of 324 to 73. However, the conference with the Senate" was unable to
work out differences in the bills in the time remaining.

ri?^^"' ^/'it^rlalp and Environment : A Report to the National Commission on Materia]i=!
ancy , ^ational Academy of Sciences — National Academy of Engineers, p. 12 (March

416

In the 94th Congress, the Subcommittee on Consumer Protection
and Finance held hearings on June 16, July 9, 10, and 11, 1975, which
focused on the bills H.R. 7229, H.R. 7548 and H.R. 7664, introduced
by Mr. Eckhardt, Mr. Brodhead, and Mr. McCollister, respectively.
After the hearings, Mr. Eckhardt introduced a new bill, H.R. 10318,
which reflected comments received during the hearings. The Subcom-
mittee reported H.R. 10318 on December 3, 1975. The full Committee
began consideration of the legislation on May 26, 1976. The Commit-
tee agreed to substitute H.R. 14032, introduced by Mr. Eckhardt and
Mr. Broyhill, for H.R. 10318. After three days of mark-up, this bill
with certain amendments was reported by the full Committee by
voice vote.

Cost of Legislation

In accordance with clause 7(a) of rule XIH of the Rules of the
House of Representatives, the committee estimates that the following
costs will be incurred in carrying out the functions under H.R. 14032 :

Fiscal year : Millions

1978 . $11.1

1979 „ 10.1

1980 11.1

The Environmental Protection Agency, which will administer the
bill, has tarnsmitted its projected resource requirements for purposes
of the authorization of appropriations contained in H.R. 14032 :

Fiscal year : Millions

1978 $12,625

1979 16.2

1980 17.35

1981 17.35

1982 17.35

Section-By- Section Analysis

section 1, short title

Section 1 of the bill provides that the bill when enacted may be
cited as the "Toxic Substances Control Act".

SECTION 2, FINDINGS, POLICY, AND INTENT

Subsection (a) of section 2 contains Congressional findings that (1)
humans and the environment are being exposed to a large number of
chemical substances and mixtures each year; (2) some of these chemi-
cal substances and mixtures may cause or significantly contribute to
an unreasonable risk to health or the environment; and (3) the effec-
tive regulation of such chemical substances and mixtures in interstate
commerce necessitates the regulation of such substances and mixtures
in intrastate commerce as well.

417

The Committee has extended the reach of the regulatory authority
of the bill to all chemical substances and mixtures whether in interstate
commerce or not since the size and scope of the chemical industry makes
it impossible to distinguish between those in interstate commerce and
those which are not. Further, commerce in those which are arguably
only in intrastate commerce may affect commerce in those which are in
interstate commerce, and consequently there cannot be effective regu-
lation of the latter w^ithout regulation of the former. Also regulation
of only those in interstate commerce without regulation of the others
could depress commerce and discriminate against those in interstate
commerce and adversely burden, obstruct, and affect such commerce.

Subsection (b) provides that it is the policy of the United States that
(1) hazardous and potentially hazardous chemical substances and mix-
tures should be adequately tested with respect to their effect on health
and the environment; (2) such testing should be the responsibility of
those who manufacture or process the chemical substances or mixtures ;
(3) adequate authority should exist to regulate chemical substances and
mixtures which may cause or significantly contribute to an unreason-
able risk to health or the environment, and to take action with respect
to chemical substances and mixtures which are imminently hazardous;
and (4) these authorities should be exercised so as not to unduly im-
pede or create unnecessary economic barriers to technological innova-
tion while assuring that such chemical substances and mixtures do not
cause or significantly contribute to an unreasonable risk to health or
the environment.

Subsection (c) of section 2 provides that it is the intent of Con-
gress that the Administrator of the Environmental Protection Agency
shall carry out the bill in a reasonable and prudent manner, and that
the Administrator shall consider the environmental, economic, and so-
cial impact of any action proposed to be taken under the bill.

The Committee intends subsection (c) for the guidance of the Ad-
ministrator in fulfilling the purposes of the bill. However, this state-
ment of intent by the Committee as to the manner in which the Ad-
ministrator is to exercise the authorities and fulfill the Administrator's
responsibilities under the bill is not to be construed as a direction to the
Administrator to make any statement of findings in addition to those
required by specific provisions of the bill or to involve the Administra-
tor in any cost-benefit justifications.

SECTION 3, DEFINITIONS

Section 3 defines the terms used in the bill. While most of the
definitions are self-explanatory, a few are of particular importance
and merit discussion.

The term "Administrator" means the Administrator of the Environ-
mental Protection Agency.

418

The bill grants the Administrator certain regulatory authority over
"chemical substances" and "mixtures" of chemical substances. The
term "chemical substance" is defined in this section to mean any or-
ganic or inorganic substance of a particular molecular identity, includ-
ing a combination of such substances occurring in whole or in part as
a result of a chemical reaction or in nature. The term also includes any
element or uncombined radical.

The Committee recognizes that basically everything in our environ-
ment is composed of chemical substances and tnerefore the definition
of "chemical substances" is necessarily somewhat broad. However, be-
cause of the breadth of the definition, the Committee has carefully
defined the authorities of the Administrator respecting such
substances.

Certain categories are specifically exempted from the term "chemi-
cal substance" and thus are exempted from coverage under the bill.
Pesticides (as defined in the Federal Insecticide, Fungicide, and Ro-
denticide Act) when manufactured, processed, or distributed in com-
merce for use as a pesticide; tobacco or tobacco products; source
material, special nuclear material, and byproduct material (as de-
fined in the Atomic Energy Act of 1954 and regulations issued under
that Act) ; and articles w^hich if sold would be subject to the tax
imposed by section 4181 of the Internal Revenue Code of 1954 (i.e.,
pistols, firearms, revolvers, shells and cartridges) .

Although the language of the bill is clear on its face as to the
exemption for pistols, revolvers, firearms, shells, and cartridges, the
Committee wishes to emphasize that it does not intend that the legisla-
tion be used as a vehicle for gun control. Consequently the Administra-
tor has no authority to regulate ammunition as an unreasonable risk
because it injures people when fired from a gun. However, the Com-
mittee does not exclude from regulation under the bill chemical com-
ponents of ammunition which could be hazardous because of their
chemical properties.

Also excluded from the definition of the term chemical substance
and consequently from coverage under the bill are any food, food addi-
tive, drug, cosmetic, or device when manufactured, processed, or dis-
tributed in commerce for use as a food, food additive, drug, cosmetic,
or device. As used in this exclusion, the terms "food", "food additive",
"drug", "cosmetic", and "device" have the same meaning as is given
them by section 201 of the Federal Food, Drug, and Cosmetic Act. The
intent of the Committee in excluding these items is to exclude from
coverage under the bill items which may be regulated under the Fed-
eral Food, Drug, and Cosmetic Act. By adopting the definitions given
the items by that Act the Committee has made the exclusion of these
items from the bill coextensive with the authority to regulate them
under the Federal Food, Drug, and Cosmetic Act. Thus, if an item
cannot be regulated as a food, food additive, drug, cosmetic, or deface
under that Act because it does not come within the definitions in that
Act, it is not the intent of the Committee to exclude it from coverage
under the bill.

An amendment was offered during Committee consideration of the
bill to add a provision which would add to the exclusion described
above an exclusion of "any substance produced for research and devel^

419

opment purposes and intended only for use in or on any such food,
drug, cosmetic, or device". It was stated that the intent of the amend-
ment was to make it clear that catalysts, intermediates, and precursors
which are intended for use in the production of drugs in their final
dosage forms or substances which are used in research and develop-
ment of drugs and which do not necessarily become ingredients of the
drugs in their final dosage forms would not be subject to regulation
under the bill. The amendment was withdrawn with the understand-
ing that the definition of the term "drug" in the Federal Food, Drug,
and Cosmetic Act included the items described in the amendment, but
that to the extent that any such item is not included in that definition
and thus not subject to regulation under that Act, such item should be
subject to regulation under the bill.

The definition of "drug" in the Federal Food, Drug, and Cosmetic
Act includes "articles intended for use as a component" of substances
included in the definition of "drug". As used in that Act, the term
"component" does not mean only an item which may be identified as an
ingredient of a drug in its final dosage form. Component includes any
item used in the production of the drug. Thus, precursors, intermedi-
ates, and catalysts intended for use in the production of drugs in their
final dosage form are "drugs" within the meaning of the Federal Food,
Drug, and Cosmetic Act.

Further, the Federal Food, Drug, and Cosmetic Act clearly covers
drugs during the "investigation" or research stage. Consequently, the
definition of "drug" in that Act includes chemical substances used for
drug research and development. The same is true of the definitions of
food, food additives, and cosmetics.

Likewise, the definition of pesticide in the Federal Insecticide,
Fungicide, and Rodenticide Act defines "pesticide" to include "(1)
any substance or mixture of substances intended for preventing, de-
stroying, repelling, or mitigating any pevSt, and (2) any substance or
mixture of substances intended for use as a plant regulator, defoliant,
or desiccant." Thus the definition in that Act would include chemical
substances on which research is being performed with the intent that
the substance be used for any of the purposes described in the defini-
tion of the terui "pesticide". Such substances would be subject to regu-
lation under that Act and, by virtue of the exemption for pesticides,
are exempted from regulation under this bill.

The exclusion from the definition for any pesticide, food, food addi-
tive, drug, cosmetic, or device is conditioned upon its being manufac-
tured or distributed in commerce for use as a pesticide, food, food ad-
ditive, drug, cosmetic, or device. Such a condition is necessary because
some chemical substances and mixtures which can be used as pesticides,
foods, food additives, drugs, or cosmetics can also be used for other
purposes. For example, aluminum subacetate is used as a burn treat-
ment, but it is also used as a mordant in dyeing and for flame-proofing.
Cuprous oxide is used as a pesticide, but it also is used as a flame-
retardant.

Aluminum subacetate when used in dyeing or for flame-proofing
could not be regulated under the Federal Food, Drug, and Cosmetic
Act. nor could cuprous oxide when used as a flame-retardant be regu-
lated under the Federal Insecticide, Fungicide, and Rodenticide Act.

420

The Committee bill assures that the exemption will extend only insofar
as the exempted substance or mixture is actually manufactured, proc-
essed, or distributed in commerce for use as a pesticide, food, food ad*
ditive, drug, cosmetic, or device and thus is subject to regulation under
the Federal Food, Drug, and Cosmetic Act or the Federal Insecticide, i
Fungicide, and Rodenticide Act.

Although the term chemical substance excludes mixtures of chemi-
cal substances, mixtures are not excluded from regulation under the
bill. However, mixtures are regulated in a different manner than
chemical substances — they are not subject to the manufacturing and
processing notices for new chemical substances under section 5 and
special findings are required before testing of them may be required
or before they can be subject to rules under section 8(a) requiring
recordkeeping and reporting for them. Consequently, it was necessary
to establish chemical substances and mixtures as two separate identi-
fiable terms.

The term "mixture" is defined to mean any combination of two or
more chemical substances if the combination does not occur in nature
and is not, in whole or in part, the result of a chemical reaction. Certain
combinations of chemical substances which do occur, in whole or in :
part, as a result of a chemical reaction are included within the term i
mixture and thereby excluded from the definition of chemical sub-
stance. If each of the chemical substances comprising the combination
is not a new chemical substance and if the combination could have
been manufactured for commercial purposes without a chemical re-
action at the time the substances comprising the combination were
combined, then the combination will be a mixture rather than a chemi-
cal substance.

The inclusion of such reaction-produced combinations within the
definition of mixture is necessary to prevent disparate treatment of
identical combinations simply because of the number of steps used in
the production of the combination. For example, a soap product may ,
be manufactured by combining coconut oil soap, sodium tri-poly phos- ;
phate, sodium sulphate, and sodium bicarbonate. T^Tien combined, ;
these four in<rredients do not react chemically. Thus if a manufacturer
combined the four ingredients, the resulting combination would clearly
be considered a mixture. However, if another manufacturer simul- ^
taneously mixed two substances which react to form coconut oil soap,
the first ingredient, together with the latter three ingredients, the;
resulting combination would have been produced in part by a chemi- !
cal reaction. The two end products would be identical, and they should j
be subject to identical treatment under the bill. The Committee defini-^
tion assures that they will be. i

The term "environment" is broadly defined to include water, air, and
land and the interrelationship which exists among and between water,,
air, land and all living things. Thus by providing for the protection
of the enviroTiment. the bill includes protection for all living things
within the environment.

The term "manufacture" means to import, produce, or manufacture.
As a result, imported chemical substances and mixtures will be sub-
ject to re.<ru1ation in the same manner as domestically produced chemi-
cal substances and mixtures are. In addition, importers of chemical

421

substances and mixtures will have the same responsibilities and obliga-
tions as domestic manufacturers.

The bill does not attempt in the definition of the term "manufac-
ture" to define exactly what activities are to be included in that term
because the activities embraced by the term are generally well under-
stood. However, it has come to the attention of the Committee that
there are activities incidental to the end use or storage of certain sub-
stances or mixtures which under a literal reading of the definition
would make a person engaging in them a manufacturer and thus sub-
ject to the provisions of the bill applying to manufacturers.

For example, there are certain substances or mixtures, such as ad-
hesives, paints, inks, and drying oils, which during storage or upon
end use, when exposed to environmental factors such as air, moisture,
or sunlight, undergo a chemical reaction which produces a different
substance or mixture. Similarly, plastic resins subjected to heat for
purposes of molding undergo a thermal setting which produces a
different substance. In such cases, the chemical reaction is merely
incidental to the end use or storage of the original substance or mix-
ture. The substance or mixture produced is not used as a chemical
substance or mixture, per se. It is not the Committee's intent that a
person, such as a painter, who is engaged in the end use or storage
activity in which such a chemical reaction occurs is to be considered
a manufacturer because of the reaction. Thus, such a person would not
be subject to the notification requirements of section 5 even though
a chemical substance resulting from the reaction is not included on
the inventory compiled under section 8(b). Substances which occur
incidenta^y to the storage or end use of such combinations should
be considered as byproducts, and the responsibility for meeting the
testing, notification, and other requirements with which manufac-
turers must comply would fall upon the manufacturer of the substance
jOr mixture from which the byproduct is produced.

For example, there are certain combinations of substances, such as
adhesiA'es, paints, inks, and drying oils, which during storage or upon
end use, when exposed to environmental factors such as air, moisture,
or sunlight, undergo a chemical reaction which technically produces
a different chemical substance. However, the chemical reaction is
imerely incidental to the storage or end use of the substances. The
substance produced is not to be used as a chemical substance, per se.

It is the Committee's intent that a person who is engaged in a
use or storage activity in which such a chemical reaction occurs
is not to be subject to the notification requirements of section 5
even though the chemical substance resulting from such activity is not
included on the inventory compiled under section 8(b). Substances
which occur incidentally to the storage or use of such combinations
should be considered as byproducts and the responsibility for meeting
the requirements of the bill respecting such byproducts is to be met
by the manufacturer of the substance from which the byproduct is
produced.

I During the hearings, a number of witnesses recommended that the
[bill include a definition of unreasonable risk. Because the determina-
^tion of unreasonable risk involves a consideration of probability, se-
' verity, and similar factors which cannot be defined in precise terms

422

and is not a factual determination but rather requires the exercise of
judgment on the part of the person making it, the Committee did not
attempt a definition of such risk. In general, a determination that a
risk associated with a chemicaf substance or mixture is unreasonable
involves balancing the probability that harm will occur and the mag-
nitude and severity o.f that harm against the effect of proposed regu-
latory action on the availability to society of the benefits of the sub-
stance or mixture, taking into account the availability of substitutes
for the substance or mixture which do not require regulation, and
other adverse effects which such proposed action may have on society.

The balancing process described above does not require a formal
benefit-cost anal^^sis under which a monetary value is assigned to the
risks associated with a substance and to the cost to society of proposed
regulatory action on the availability of such benefits. Because a mone-
tary value often cannot be assigned to a benefit or cost, such an analy-
sis would not be very useful.^

As noted above, the Committee recognizes that risk is measured
not solely by the probability of harm, but instead includes elements
both of probability of harm and severity of harm and those elements
may vary in relation to each other. Thus, the Administrator may
properly find that health or the environment are exposed to an unrea-
sonable risk by a lesser probability of a greater harm as well as by a
greater probability of a lesser harm.

Although the standard for defining the regulatory autht)rity of the
Administrator throughout the bill is "unreasonable risk", the imple-
mentation of the standard will of necessity vary depending on the
specific regulatory authority which the Administrator seeks to exer-
cise. For example, a testing rule under section 4 will ordinarily not
result in depriving the public of the benefits of a substance or mixture
subject to the rule. This is because such a rule does not prohibit the
manufacture, processing, etc., of existing substances or of mixtures. At
the most a testing rule may, through section 5(d), delay the Com-
mercial availability of new substances and new uses of existing sub-
stances subject to the testing rule. Similarly, a requirement imposed
under section 5(g) (regulation of new substances and significant new
uses of substances pending the development of information) will only
delay or restrict the availability of a substance subject to it until
adequate health and safety data can be developed and evaluated.

However, this is to be contrasted with the effect of the imposition
of a requirement under section 6 on a substance. Such a requirement
may remove a substance from the market or impose lesser restrictions
on its availability and such a requirement is not of limited duration.
Thus, the effect on societj may be far reaching. As a result regulatory
effect will be of greater significance in a determination of unreasonable
risk for purposes of section 6 than for a determination for purposes of
section 4 or 5(g). Conversely, with respect to section 4 or 5(g), be-

lA recent study by the National Academy of Sciences on regulating chemicals agrees.
It states : "Highly formalized methods of benefit-cost analysis seldom can be used for
making decisions about regulating chemicals in the environment. Thus the development
of such methods should not ha\e high priority." Decision Making for Regulating Chemicals
in the Environment, Comnilttee on Principles of Decision Malting for Regulating Chemi-
cals In the Environment, Environmental Studies Board, Commission on Natural Resources,
National Research Council, National Academy of Sciences, xxv (July, 1975).

423

cause the regulatory effect of action taken under either of those sec-
tions is less than that of action taken under section 6, the requirements
for a determination of unreasonable risk for purposes of section 4 or
5 (g) are less demanding.

The Committee has limited the Administrator to taking action only
against unreasonable risks because to do otherwise assumes that a
risk-free society is attainable, an assumption that the Committee does
not make.

424

SECTIOX 4, TESTING OF CHEMICAL SUBSTANCES AND MIXTURES

Section 4 vests in the Administrator the authority necessary to
accomplish one of the basic policy objectives of the bill: to require
manufacturers and processors to bear the responsibility for ade-
quately testing potentially dangerous chemical substances and mix-
tures to ascertain their health and environmental effects. The section
may be made applicable to existing and new chemical substances and
to mixtures.

When testing should he required

Sections 4(a) (1) (A) and 4(a) (1) (B) describe when the Adminis-
trator shall promulgate rules requiring manufacturers and processors
to test a chemical substance or mixture. Both sections 4(a)(1)(A)
and 4(a) (1) (B) require the Administrator to make certain findings,
and absent those findings testing may not be required.

Section 4(a)(1)(A) states that if the Administrator finds that
(1) the manufacture, distribution in commerce, processing, use or
disposal of a chemical substance or mixture or any combination of
such actions may cause or significantly contribute to an unreasonable
risk to health or the environment, (2) there are insufficient data and
experience to reasonably determine or predict the effects of such
activity, and (3) testing of such substance or mixture is necessary
to develop predictive data, and (4) in the case of a mixture, the effects
may not be reasonably and more efficiently determined or predicted
by testing the chemical substances which comprise the mixture, then
the Administrator shall by rule require testing of the .substance
or mixture.

The finding that a substance or mixture may cause or significantly
contribute to an unreasonable risk is intended by the Committee to
focus the Administrator's attention on those chemical substances
and mixtures about which there is a basis for concern, but about which
there is inadequate information to reasonably predict or determine
the effects of the substance or mixture on health or the environment.
For example, if one substance is structurally similar to a second
chemical with known adverse health or environmental effects, the
Administrator could reasonably conclude that the first chemical may
cause or significantly contribute to an unreasonable risk. Or if there
is reliable preliminary data indicating that a substance may be
dangerous, again it would be reasonable to conclude that such chemi-
cal may cause or significantly contribute to an unreasonable risk.

It should be noted that the bill does not require the Administrator
tp find that a substance or mixture does cause or significantly con-
tribute to or will cause or significantly contribute to an unreasonable
risk. Such a finding requirement would defeat the purpose of the sec-
tion, for if the Administrator is able to make such a determination.

(17)

425

regulatory action to protect against the risk, not additional testing, is
called for. However, the term "may" as used in the phrase "may cause
or significantly contribute to" does not permit the Administrator to
make a finding respecting probability of a risk on the basis of mere
conjecture or speculation, i.e., it may or may not cause a risk.

Section 4(a)(1)(B) sets forth the second set of conditions under
which the Administrator is to require testing. If the Administrator
finds that (1) a substance or mixture is or will be produced in sub-
stantial quantities and that it enters or may reasonably be anticipated
to enter the environment in substantial quantities or there is or may be
significant or substantial human exposure to the substance or mixture,
(2) there are insufficient data and experience upon which to determine
or predict the effects of the manufacture, distribution in commerce,
processing, use, or disposal of the substance or mixture, (3) testing is
necessary to develop predictive data, and (4) in the case of a mixture,
the effects may not be reasonably and more efficiently determined or
predicted by testing the chemical substances which comprise the mix-
ture, then the Administrator shall by rule require testing of the sub-
stance or mixture.

The conditions specified in section 4(a)(1)(B) reflect the Com-
mittee's recognition that there are certain situations in which testing
is desirable even though there is an absence of information indicating
that the substance or mixture may be harmful.

In making the finding that there is or will be substantial production
coupled with substantial environmental or human exposure to a sub-
stance or mixture, the Administrator is not limited to consideration of
sheer volume of production or exposure at a specific point in time. The
duration of the exposure, the level of or intensity of exposure at vari-
ous periods of time, the number of people exposed, or the extent of
environmental exposure are among the considerations which may be
relevant in particular circumstances.

In both sections 4(a) (1) (A) and 4(a) (1) (B) a finding that there
are insufficient data and experience upon which to determine or pre-
dict the effects of a substance or mixture is required. The Committee
included this finding in each provision to elimihate unnecessary or
duplicative testing! The Committee recognizes that experience with a
chemical substance or mixture, as well as test data, may be useful in
determining or predicting the effects of a substance or mixture. Ex-
perience may be particularly valuable in evaluating acute effects.
However, the value of experience may be diminished with respect to
effects of chronic exposure to a substance or mixture depending on the
type of suspected harm and the length of experience with such sub-
stance or mixture.

The additional finding required with respect to a mixture (i.e., that
the effects which the mixture's manufacture, distribution in com-
merce, processing, use, or disposal may have on health or the environ-
ment may not be reasonably and more efficiently determined or pre-
dicted by testing the chemical substances which comprise the mixture)
is also intended to reduce unnecessary or duplicative testing. The
assessment of safety of a mixture may well be based upon the toxicity
of particular components, and tests of the entire mixture with its vary-
ing component ratios may be unnecessary or unrewarding. At the same
time, the Committee recognizes that there may be instances in which

I 79-313 0 - 77 - 28

426

a particular combination must be tested to reasonably evaluate the
effects of the mixture. For instance, the effect of two chemicals, when
combined, may be greater than the sum of the effects of the compo-
nents taken independently. The Committee bill does not prohibit the
Administrator from requiring testing of the mixture in such instances.

Contents of testing rule

Section 4(b) (1) requires a testing rule to identify the substance or
mixture for which testing is required, include the standards for the
development of test data, and specify the period of time within which
the testing results shall be submitted to the Administrator. The period
specified for conducting the testing and submitting results to the Ad-
ministrator may not be unreasonable.

In determining the standards for the development of test data and
the period for conducting the testing, the Admmistrator is to consider
the relative costs of various test protocols and methodologies. The
Committee recognizes that testing may, in some instances, involve con-
siderable costs for a manufacturer or processor. To the extent con-
sistent with the purpose of the bill and the public need for timely,
thorough, and reliable data, the Administrator should attempt to min-
imize testing costs.

The Administrator is also to consider, in determining the standards
and period for testing, the reasonably foreseeable availability of fa-
cilities and personnel for performing testing under the rule. Such con-
sideration need not be limited to existing testing resources and
personnel but might also include the anticipated increase in supply
of such resources and personnel to meet increased demand. The test-
ing rule may require the submission of preliminary data prior to the
time the final data is to be submitted to the Administrator. As a result,
the Administrator may check to insure that the testing data is being
developed in a reliable and competent manner in compliance with the
standard for the development of test data. Failure to comply with
such standard would, of course, be a prohibited act under section 15.

Section 4(b) (2) (A) lists some of the health and environmental
effects for which a standard for the development of test data may be
rescribed. It also lists some of the testing methodologies which may
e prescribed in the standard, including epidemiology, serial, or hier-
archical tests, in vitro tests, and whole animal tests. The Committee
considered and rejected an amendment which would have instructed
the Administrator to give preference to tests which do not involve
the use of animals if other tests provide an adequate and accurate
means for ascertaining the effect of a chemical substance or mixture
on health or the environment. The Committee determined not to so
limit the Administrator's discretion since protection of human health
demands that the Administrator not be denied the best, most reliable
data possible. However the Committee does not intend that the Ad-
ministrator needlessly require whole animal tests. The Administrator
should consider alternative test methods. With the development of
reliable non-animal tests for predicting the long-term effects of chem-
icals on health, the need for animal test data to determine if a sub-
stance or mixture causes or significantly contributes to an unreason-
able risk will diminish.

427

Before prescribing epidemiology tests, the Administrator is re-
quired to consult with the Director of the National Institute for Oc-
cupational Safety and Health. Such consultation will enable the
Administrator to acquire the expertise and experience of the Director
respecting epidemiology tests conducted under the Occupational
Safety and Health Act of 1970.

Section 4(b) (2) (B) requires the Administrator to review the test-
ing standards at least every twelve months. If necessary, the Admin-
istrator shall initiate rulemaking proceedings to make appropriate
revisions of a testing standard.

Who is to conduct the testing

In general the manufacturers and processors of a chemical sub-
stance or mixture subject to a section 4 rule are responsible for the
testing required by the rule. If two or more persons ?rc subject to the
same testing requirement, the Administrator may permit them to des-
ignate one of their number or a qualified third party to conduct the
tests and submit the test data on their behalf. However, such a desig-
nation does not relieve them of their underlying responsibility for
compliance with the testing rule. Subsection (b) (3) specifies which
manufacturers and processors are to do the testing. Under that sub-
section there nmst be a relationship between the activity of the manu-
facturer or processor and the finding made in connection with the
issuance of the rule. Thus, for example, if the Administrator makes
a finding respecting the manufacture of a substance, the persons en-
gaged in such manufacturing must do the testing. Similarly, if the
Administrator makes a finding respecting the use of a substance, the
person responsible for manufacturing or processing the substance for
that particular use would be responsible for testing.

A rule under subsection (a) requiring testing of a substance or mix-
ture shall expire at the end of the reimbursement period applicable to
the test data to be submitted pursuant to such rule. The reimburse-
ment period is the period during which the person who submits test
data is entitled to be reimbursed by any person who receives an exemp-
tion from the testing requirement based on the data submitted by the
first person.

Procedures for promulgating rules requiring testing

Section 4(b)(5) specifies the procedures by which the Administrator
is to promulgate a rule under subsection \a). Such rules are to be
promulgated in accordance with the informal rulemaking procedures
of section 553 of title 5 of the United States Code. In addition to the
procedures outlined in section 553, the Administrator shall give inter-
ested persons an opportunity for the oral presentation of data, views,
or arguments, as well as an opportunity to make written submissions.
A transcript shall be made of any oral presentation. The Administrator
may not promulgate a rule under subsection (a) unless the Admin-
istrator makes and publishes with the rule the findings described in
paragraph (1) (A) or (1) (B) of subsection (a).

Exemptions from niles requiring testing

Subsection (c) specifies when the Administrator is to exempt a
person from a requirement to conduct tests and submit test data on

428

a chemical substance or mixture. To obtain an exemption, an appli-
cant must demonstrate to the satisfaction of the Administrator that
the chemical substance or mixture (including any contaminant in the
substance or mixture) with respect to which the application is sub-
mitted is equivalent to the substance or mixture for which test data has
already been submitted or for which test data is being developed, and
that testing and submission of data by the applicant would be
duplicative.

The person granted the exemption must, if the exemption is granted
within the reimbursement period, provide fair and equitable reim-
bursement to the person upon whose testing the exemption is based
and to any other person who has been required to contribute to the
testing osts of such person. If the person granted the exemption and
those who are to be reimbursed are unable to agree upon the amount
and method of reimbursement, the Administrator may order the per-
son granted the exemption to provide fair and equitable reimburse-
ment in any amount determined under rules of the Administrator. The
Committee recognizes that burdens of testing could fall heaviest on
small companies and, therefore, to alleviate such burdens the Admin-
istrator, in promulgating such rules, is directed to consider the effect
on the competitive position of the various persons involved and their
respective share of the market. The Committee recognizes that such
rules will necessarily have to be somewhat general in scope, for the
Administrator cannot be expected to anticipate all of the specific sit-
uations which may arise. An order requiring reimbursement is to be
considered final agency action.

Public notice of receipt of test data

Subsection (d) requires the Administrator to promptly publish in
the Federal Register a notice of receipt of any test data submitted pur-
suant to a rule under subsection (a). The notice, subject to the provi-
sions of section 14 (relating to confidentiality) shall identify the sub-
stance or mixture for which data have been received, list the uses or
intended uses of the substance or mixture and the information re-
quired under the section 4(a) rule, and describe the nature of the test
data developed. Unless it is protected from disclosure by section 14,
the data shall be made available by the Administrator for examination
by any person.

Priorities for testing

Subsection (e) establishes an interagency committee to make recom-
mendations to the Administrator regarding what chemical substances
and mixtures should be considered priority candidates for the issuance
of a testing rule under section 4(a). The committee is to be composed
of representatives from the Environmental Protection Agency, the
Occupational Safety and Health Administration, the Council on En-
vironmental Quality, the National Instiiutc for Occupational Safety
and Health, the National Institute of Environmental Health Sciences,
the National Cancer Institute, the National Science Foundation, and
the Department of Commerce. During Committee deliberations, an
amendment specifying that the representative from the Department
of Commerce be selected from the National Oceanic and Atmospheric
Agency was offered. Although the amendment was ultimately with-

429

drawn, the Committee intends that the representative from the De-
partment of Commerce be able to share with the interagency commit-
tee the particular expertise and knowledge found in XOAA respecting
chemical substances and mixtures and their presence in, relationship
to, and effects on the oceans and the atmosphere.

The interagency^ committee is to submit its first list of recommenda-
tions to the Administrator within twelve months after the effective
date of the bill. Any necessary revisions in the list are to be made at
least every six months. The interagency committee's reasons for in-
cluding a substance or mixture on the list are also to be submitted to
the Administrator. The bill reported from Subconmiittee required
the interagency committee to publish its recommendations and sup-
porting reasons in the Federal Register. The substitute adopted by
the Committee deletes this requirement. Instead, the Committee bill
places the burden on the Administrator for making the list and accom-
panying reasons available to the public. The Committee bill permits
the Administrator to determine the best means for making the in-
formation available to the public. The Committee recognizes that in-
dividuals throughout the country may be interested in such informa-
tion, and the Committee does not intend that access to the informa-
tion be limited to persons who have physical access to the head-
quarters or a regional office of the Administrator.

The Committee bill also provides that the Administrator shall
provide a reasonable opportunity to any interevSted person to file
comments on the committee's recommendations. Such comments are
also to be made available to the public

The Subcommittee bill required the Administrator to either initi-
ate a rulemaking proceeding under subsection (a) to require testing
of a chemical substance or mixture recommended by the interagency
committee or to publish in the Federal Register the Administra-
tor's reasons for not initiating such a proceeding. The substitute
adopted by the Committee does not contain such a requirement. Al-
though the Committee intends that the interagency committee's
recommendations be given great weight by the Administrator, the
Committee believes it would be counterproductive to require the
Administrator to formally respond in the Federal Register to every
chemical substance or mixture recommended for testing by the inter-
agency committee on which the Administrator did not take action.
The resources of the Administrator should be concentrated on pre-
paring and promulgating testing requirements and taking other neces-
sary regulatory action to protect the public from potentially danger-
ous chemical substances and mixtures.

SECnOX 5, MAXUFACTURING AXD PROCEv«;S(XG XOTICES

In General

Section 5 sets out the notification requirements with which manu-
facturers of new chemical substances and manufacturers and proces-
sors of existing chemicals for significant new uses must comply. In
general, manufacturers of new^ chemical substances must give 90 days
notice to the Administrator prior to such manufacture of tlie new
chemical. Similarly, any person who intends to manufacture or process

430

for commercial purposes an existing chemical for a use which the
Administrator has determined, by rule, constitutes a significant new-
use of the chemical must provide 90 days notice to the Administrator
prior to such manufacture or processing.

Notice must include information respecting the substance, its chemi-
cal identity and molecular structure, proposed amount of production,
uses, and test data respecting health and environmental effects. Such
notice will give the Administrator an opportunity to review and eval-
uate information respecting the substance to determine if manufac-
ture or processing should be restricted or delayed under the authorities
in this section or other sections of the bill because the substance may
be hazardous.

For example, in the case of a substance for which there is inadequate
information to permit a reasoned evaluation of the health and envi-
ronmental effects and which may, in the absence of such information,
cause or significantly contribute to an unreasonable risk, the Adminis-
trator can in section 5(g), through court order and rulemaking, delay
the manufacture or processing of the substance pending the develop-
ment of such information. The provisions of section 5 reflect the Com-
mittee's recognition that the most desirable time to determine the
health and environmental effects of a substance is before commercial
production begins. Not only are human and environmental harm
avoided or alleviated, but the costs of any regulatory action in terms of
loss of jobs and capital investment are minimized.

Notification for Manufacture of New Chemical Substances

Subsection (a) provides that before a person ma}^ manufacture a
new chemical substance, that is, a chemical substance which is not
included on the inventory published under section 8(b), the person
must notify the Administrator at least 90 days before such manu-
facture unless the substance is exempt from the notification require-
ment by the provisions of subsection (i). If a rule requiring testing of
the substance has been promulgated under section 4 before the sub-
mission of the notice and is applicable to such person, then the data
required to be developed and submitted under the testing rule must
be submitted to the Administrator at least ninety days before begin-
ning such manufacture.

Chemical /Substances for a Significant New Use

Subsection (b) (1) provides that at least ninety days before begin-
ning to manufacture or process a chemical substance for a use which
the Administrator determines, by rule, is a significant new use of such
subvStance, the manufacturer or processor must notify the Administra-
tor unless the substance is exempted from the notification require-
ments by subsection (i). If before the submission of such notice, the
manufacturer or processor is required by a testing rule in effect under
section 4 to submit test data for such substance, then such person shall
submit to the Administrator in accordance with such rule such data
at least 90 days before beginning such manufacture or processing.

Subsection (b) (2) requires that a determination by the Adminis-
trator that a new use of an existing chemical substance is a significant
new use for which notification is required shall be made by rule. In
making such a determination, the Administrator is to consider all

431

relevant factors, including the projected volume of manufacturinff
and processing of such substance for such use, the extent to which
such use changes the type or form of exposure of humans or the en-
vironment to such substance, and the extent to which such use increases
the magnitude and duration of exposure of humans or the environ-
ment to the substance.

The Committee has required that the determination that a new use
constitutes a significant ne.v use be made by rule in order to assure
that such determination will not be made in an arbitrary manner.

By limiting the notification requirements for existing chemical sub-
stances to ones to be manufactured or processed for significant, new
uses, the Committee intends to indicate that only when a new use of
a substance may reasonably be expected to have health or environ-
mental importance should it be subjected to the notification require-
ment. Ordinarily, where the projected volume of a new use is small,
the Committee anticipates that the Administrator would not make
a determination that such use constitutes a significant new use unless
there is a significant change in the type or form of human or en-
vironmental exposure, a significant increase in the magnitude and
duration of human or environmental exposure, or unless there are
other factors indicating that any such use of the substance should be
considered significant.

It has been suggested to the Committee that the Administrator
could determine that any new use of a particular substance will be
considered significant. The Committee does not intend that a new
use be considered a significant new use solely on the basis that the use
is new. However^ because of the nature of a substance, it is possible
that any new use of it will be significant. Thus a potentially dan-
gerous substance which is manufactured for a particular use may, if
manufactured for a different use present additional health or environ-
mental problems and consenuently there should be notice of the intent
to manufacture it for such different use.

Listed Chemical Suhstanees

Within twelve, months after the effective date of the bill, the
Administrator shall, by rule, compile a list of chemical substances the
manufacture, processing, distribution in commerce, use, or disposal
of which (or any combination thereof) the Administrator finds causes
or significantly contributes to or may cause or significantly contribute
to an unreasonable risk. At the same time, the Administrator shall
identify those uses of listed chemicals which the Administrator deter-
mines, in accordance with section 5(b)(2), are significant new uses.
The Administrator shall revise the list from time to time.

Under subsection (c) before a person may —

(1) Manufacture a listed chemical substance which was a new
chemical substance at the time of publication of the earliest pro-
posed rule listing such substance, or

(2) Manufacture or process a listed chemical substance for a
use determined by the Administrator to be a significant new use,

the person must notify the Administrator, unless the substance is
exempted from the notification requirements by subsection (i). At

432

least 90 days before such manufacture or processing, health and safety
data respecting such substance must be submitted to the Administrator
as provided in subsection (d).

A rule (and any amendment to or repeal of such rule) listing a
chemical substance is to be promulgated pursuant to the informal
rulemaking procedures prescribed by section 553 of title 5, United
States Code, except that there is to be an opportunity for the oral
presentation of data, views, or arguments. A transcript is to be kept
of any such oral presentation.

Submission of Test Data

Subsection (d) describes the instances in which a person subject to
a notification requirement respecting a chemical substance under sub-
section (a), (b), or (c) must submit test data to the Administrator
before manufacture or processing of such substance can begin. It is
important to note that the requirements of subsection (d) respecting
submission of data are in addition to the notice requirements of sub-
section (a), (b), or (c). Compliance with subsection (d) does not
waive compliance with the notice requirements.

Under subsection (d) (1) if a testing rule under section 4 respecting
}i substance has been promulgated before submission of the notice re-
quired by subsection (a), (b), or (c), then a person who is required
by such rule to submit test data for the substance may not manufac-
ture or process such substance until ninety days after submission of the
test data required by such rule.

Even though a person has been granted an exemption from the test-
ing rule under section 4, such person is prohibited from manufactur-
ing or processing such substance until ninety days after the submission
of the test data.

It should be noted that if a testing rule under section 4 respecting
a substance has not been promulgated prior to the submission of a
notice required by section 5, the Administrator may promulgate a test-
ing rule under section 4 for such substance. However, such a rule
would not delay the manufacture or processing of the substance.

If a person is required by subsection (c) (listed chemical sub-
stances) to provide a notice respecting the manufacturing or process-
ing of a chemical substance and is not required by subsection (d) (1)
to submit test data to the Administrator, then subsection (d) (2) im-
poses certain test data submission requirements on such person. Under
subsection (d) (2) such person must submit to the Administrator data
respecting such substance which such person believes shows that —

(1) In the case of a new chemical substance, its manufacture,
processing:, distribution in commerce, use, and disposal (or any
combination of such actions) will not cause or significantly con-
tribute to an unreasonable risk to health or the environment, and

(2) In the case of a chemical substance for a significant new-
use, such use will not cause or significantly contribute to such a
risk.

Such data must be submitted ninety days prior to the manufacture
or processing of such substance.

Data submitted under subsection (d)(1) or (d)(2) is to be made
available, subject to section 14, for examination by interested persons.

433

Extension of N otice Period

The Administrator may for good cause extend the ninety-day pe-
riods prescribed by subsections (a), (b), (c), and (d) before which
the manufacturing or processing of chemical substances subject to
such subsections may begin. Subsection (e) provides that an ex-
tension may be made only once and only for a period of not to exceed
ninety days. Notice of an extension together with the reasons for
it shall be published in the Federal Register and shall constitute final
agency action subject to judicial review.

Content of Notices

Under subsection (f)(1) the notices required by subsections (a),
(b), and (c) respecting the manufacturing or processing of a chemi-
cal substance are to indude the following: (1) the name of the sub-
stance; (2) insofar as reasonably ascertainable, (A) its chemical iden-
ity and molecular structure, (B) proposed categories of use and
imount proposed to be manufactured for each such category, and
(C) description of byproducts; (3) a reasonable estimate of the
imount of the substance to be manufactured or processed ; and (4) test
lata in the possession or control of the person giving the notice which
i-elate to the health or environmental effects of the substance. Reason-
ibly ascertainable should be interpreted to mean that which can be
)btained without unreasonable cost or burden. Such a notice is, sub-
ject to section 14, to be made available for examination by interested
persons.

Under subsection (f ) (2) the Administrator is required to publish
m the Federal Register a notice which (1) identifies a chemical sub-
stance for which a notice or data has been submitted under subsection
(a), (b), (c), or (d), (2) identifies its uses or intended uses, and
(3) if data has been submitted, describes the nature of the tests per-
formed and the data developed. Such a notice is to be published not
later than five working days after the date of the receipt of tlie infor-
mation. Unless the Administrator determines that the public interest
requires a more specific identification, chemical substances shall be
dentified in the Administrator's notice by generic class.

Regulation Pending Development of Information

There will be instances in which the Administrator will have insufH-
iient information to make a reasoned evaluation of the health and
environmental effects of a chemical substance for which notice has
Deen submitted under subsection (a), (b), or (c) (that is a new
chemical substance, a chemical substance to be manufactured or proc-
essed for a significant new use, or a listed chemical substance). The
A^dministrator may determine that without such information the sub-
stance, because of the proposed volume of production of such a sub-
stance, the nature or extent of the human or environmental exposure
which may be expected, the similarity with substances known to be
associated with an unreasonable risk to health or the environment,
3r other relevant factors, may cause or significantly contribute to such
I risk.

Subsection (g) provides the authority under which such a chemical
substance may be regulated (that is, be mad^ subject to manufacture

434

ing, processing, or distribution prohibitions or limitations, or label-
ing or disposal requirements) while information is developed to
permit a reavSoned evaluation of its health and environmental effects
and to determine if such regulation should be continued.

Under subsection (g) (1) the process for regulation of a substance
under this subsection is begun by an application made by the Admin-
istrator, acting through attorneys of the Environmental Protection
Agency, to a district court of the United States for the issuance of an
injunction to prevent the manufacture, processing, or distribution
in commerce of such substance. The district courts are granted juris-
diction to grant such an injunction if the court finds that information
available to the Administrator is insufficient to permit a reasoned
evaluation of the effects of manufacture, processing, distribution in
commerce, use, or disposal of the substance, or any combination of
such activities on health or the environment and in the absence of
such information, such activity may cause or significantly contribute
to an unreasonable risk to health or the environment.

In granting jurisdiction to the Federal district courts, the Commit-
tee intends that the two-part standard set out in subsection (g) (1)
(A) (i) and (ii) for the issuance of an injunction totally supplant the
traditional elements which a party ordinarily must show before a court
will exercise its equitable jurisdiction to grant an injunction. The Com-
mittee does not intend that the Administrator be required to make any
showing other than that which is required for the court to make the
two findings described in subsection (g)(l)(A)(i) and (ii). Upon
such a showing, the Administrator is entitled to an injunction. See
FTC V. National Commission on Egg Nutrition (517 F. 2d 485 (7th
Cir. 1975)). Application of any otlfier standard by the court will
frustrate the purposes of the section.

If the court issues an injunction, the Administrator has five days
within which to begin the proceeding for the issuance of a rule to
apply to the substance one or more of the requirements described in
section 6(a). The purpose of the proceeding is to determine which of
the requirements described in section 6(a) (i.e., manufacturing, proc-
essing, or distribution limitations or prohibitions, labeling or disposal
requirements) is necessary to apply to adequately protect health or
environment from the risk found by the court. The reference to sec-
tion 6(a) is a reference only to the kinds of requirements described
therein and is not to be construed as imposing upon the Administrator
the duty to make any of the findings contained in section 6 or to meet
any other requirement of that section other than the procedural re-
quirements of section 6(c) (2) and (3).

The proceeding is to be conducted in accordance with the procedures
described in paragraphs (2) and (3) of section 6(c). The proceeding
is to be an expedited one in that a requested hearing is to be held
within 15 days of receipt of a request for such a hearing (unless the
parties agree to a different time) and the Administrator is to make
a decision on the rule within 30 days of the conclusion of the hearing.

Subsection (g) (3) permits any jperson to petition the Administra-
tor to initiate a proceeding to amend or repeal a rule issued under
subsection (g). Thus, when data sufficient to permit a reasoned evalu-

435

ation of the health or environmental effects of the substance have been
developed, a person subject to the section 5(g) fule could petition
the Administrator to amend or repeal the rule if appropriate in light
of the data developed. Within thirty days, the Administrator must
by order either grant or deny the petition. If the petition is granted,
the Administrator shall promptly initiate a proceeding, in accord-
ance with paragraphs (2) and (3) of section 6(c) for the amendment
or repeal of the rule. It should be noted that granting the petition
does not obligate the Administrator to modify or repeal the rule as
requested. Granting a petition only triggers the requirement to ini-
tiate a proceeding. Final action by the Administrator will, of course,
depend on the record developed during the proceeding.

Petition for Standards for the Development of Test Data

Under subsection (h) a person intending to manufacture or process
a substance for which notice is required under subsection (a), (b),
or (c) and who is not required by a rule under section 4 to submit
test data on such substance may petition the Administrator to pre-
scribe standards for the development of test data for such substance.
The Administrator must act on the petition within 60 days of its
receipt, and, if the Administrator grants the petition, the Adminis-
trator must prescribe such standards within 75 days of granting the
petition. This provision is included primarily to assist persons intend-
ing to manufacture or process a listed chemical substance for which
test data is required by subsection (d) and to assist persons who wish
to develop data to make the continued imposition of a requirement
under subsection (g) no longer necessary.

The Committee finticipates that such manufacturers or processors
will first consult informally with the Administrator's technical staff
to obtain guidance respecting the testing of the substance. Only if
' such consultation fails to be productive should a petition be necessary.
Of course, the Administrator could issue a rule requiring testing of a
substance under section 4 even though the Administrator had previ-
ously prescribed a standard for the development of test data in re-
^onse to a petition .under subsection (h) .

Exemptions

I Subsection (i) prescribes the situations in which a chemical sub-
■ stance may be manufactured or processed without regard to the notice

and test data submission requirements of subsections (a), (b), (c),

and (d).

Paragraph (1) provides the authority for an exemption with respect
; to thp. manufacturing and processing of a chemical substance for test
marketing purposes. To obtain such an exemption an application must
be submitted to the Administrator. The application must satisfactorily
demonstrate to the Administrator that the manufacture, processing,
distribution in commerce, use, and disposal for test marketing pur-
poses of the substance for which the application is submitted will not
cause or significantly contribute to any unreasonable risk to health or
the environment. Such an exemption may be granted upon such restric-
tions as the Administrator considers appropriate. The Administrator
I is to act upon such an application within 45 days of its receipt.

436

Under paragraph (2), an exemption from the test data submission
requirements of subsection (d) (2) may be obtained for a chemical sub-
stance which is equivalent to a chemical substance for which data has
been submitted in accordance w^ith such subsection if submission of
data for the substance to be exempted would be duplicative of data
already submitted to the Administrator. The person requesting the
exemption will have the burden of showing that the substances for
which the exemption is requested is equivalent to the substance for
which data has been submitted and that submission of data would be
duplicative. If an exemption is granted under this paragraph during
the reimbursement period for the previously submitted data, then the
person who submitted such data is to be reimbursed by the person
receiving the exemption for a portion of the cost incurred in develop-
ing such data. The requirements of section 4 respecting reimbursement
also apply to reimbursement provided under this paragraph.

Subsection (i) (3) specifically exempts from the notification require-
ments of subsections (a) , (b) , and (c) those chemical substances manu-
factured or processed or proposed to be manufactured or processed
in small quantities (as defined by the Administrator by rule) for sci-
entific experimentation or analysis or for chemical research or analysis,
including research and analysis for the development of the substance
or another chemical substance into a commercial product. All persons
engaged in such experimentation, research, or analysis for a manufac-
turer or processor must be notified of any risk to health which the
manufacturer or processor has reason to believe may be associated with
the substance.

The exemption is necessary to insure that research and innovation,
both academic and commercial, is not unduly impeded by the require-
ments of section 5. For example, researchers in laboratories in col-
leges and universities, in government agencies, and elsewhere may
have important need for new substances on short notice. The subsec-
tion (i)(3) exemption will insure that the person w^ho manufactures
such new substance for the researcher will be able to provide the sub-
stance to the researcher without having to wait the ninety days re-
quired by the notification period. Further, researchers working for
a manufacturer trying to develop a product may need to make several
changes in the substance. It would be unrealistic to require that the
Administrator be notified 90 days in advance of each change made in
the substance during the course of the research or the development
period.

The research, analysis, and experimentation performed upon a
chemical during its developmental period should give a manufacturer
the opportunity to evaluate the physical, chemical, production, and
performance characteristics of the substance. Since the exemption ap-
plies only to substances manufactured or processed in small quanti-
ties and since the research and analysis will be supervised or conducted
by technically qualified individuals and since all the individuals ex-
posed to the chemical substance will be made aware of potential health
effects there should not be any unreasonable risk to health presented
as a result of the exemption.

In limiting the exemption to chemicals manufactured or processed
in "small" quantities, your Committee recognizes that the term "small"

437

cannot be viewed in an absolute sense. The amount of the chemical
substance which must be manufactured or processed for research and
analysis may vary in relationship to the kind of use for which the
chemical substance is being developed. Obviously a manufacturer must
be able to produce a chemical in sufficient quantities during the de-
velopmental period to adequately test and evaluate the chemical for
its intended use. For instance, laboratory reagents may be tested in
terms of grams, while textile fibers or paper processing materials may
have to be manufactured in much greater quantities in order to be ade-
quately evaluated.

The Committee also recognizes that a manufacturer may not. be
able to fully evaluate a potential product in -house. For example, a
manufacturer may have to use an outside testing laboratory or make
the product available to a potential industrial user to complete the
analysis or experimentation. The fact that the other industrial user
may pay for the costs of the substance does not necessarily signal the
end of the development period. So long as the purchaser is continuing
the research and evaluation of the substance by individuals technically
qualified to analyze and evaluate the physical, chemical, and perform-
ance characteristics of the substance, the exemption continues to apply.
Again, such technically qualified individuals would be made aware of
potential health and environmental effects. However, the exemption
does not permit the use of the substance in products in a test market
situation.

Subsection (g) (4) is designed to prevent a substance from being
treated as a new chemical substance solely on the basis of a change of
the inert ingredients of the substance. Under this exemption, if a
substance has been included in the inventory under section 8, the
substance which is identical to that substance except for its inert
ingredients is not to be treated as a new chemical substance and con-
sequently subject to the notice requirements of subsection (a).

Paragraph (5) authorizes the Administrator, upon application, to
issue a rule to exempt the manufacturer of a new chemical substance
from the requirements of this section (or any part of such require-
ment) if the Administrator determines that the chemical substance
will not cause or significantly contribute to an unreasonable risk to
health or the environment. A rule under this paragraph is to be
promulgated in accordance with the rulemaking procedures contained
in paragraphs (2) and (3) of section 6(c).

Definition

Subsection (j) provides that for purposes of section 5, the terms
"manufacture" and "process" means to manufacture or process for
commercial purposes. Since the term "manufacture" is defined to
include "import", persons who intend to import substances for com-
mercial purposes will be treated the same as a domestic manufacturer
under section 5.

By use of the term "for commercial purposes" the Committee does
not intend to restrict coverage to substances manufactured or processed
"for sale". Any commercial purpose, such as use as a chemical inter-
mediate in a manufacturing process, is sufficient to bring the manufac-
ture or processing of a substance wdthin the ambit of section 5. The

438

Committee realizes that there are certain minor reactions occurring
incidental to the mixing process or upon storage of a mixture, such as
the cross-linking of polymers. Such a minor reaction may result in
what would technically be considered a "new"' chemical substance.
However, since the "new" substance is not manufactured for commer-
cial purposes per se it would not be subject to the notification provi-
sions of this section.

439

SECTTION 6, REGrLATION OF HAZARDOUS CHEMICAL SUBSTANCES AND

MIXTURES

Section 6 empowei^ and directs the Administrator to take action
to protect the public from hazardous chmeical substances and mixtures.
Such action shall be taken agaiust existing chemical substances, new
chemical substances, and mixtures when there is a reasonable basis
to conclude that the substance or mixture causes or significantly con-
tributes to or will cause or significantly contribute to an unreason-
able risk.

1| Scope of regul<ition

Section 6(a) provides that if the Administrator finds that there is
a reasonable basis to conclude that the manufacture, processing, dis-
tribution in commerce, use or disposal of a chemical substance or mix-
ture (or any combination of such acti\4ties) causes or significantly
contributes to or will cause or significantly contribute to an unrea-
sonable risk to health or environment, the Administrator shall by rule
take regulatory action nec^sary to adequately protect against the

I risk. Absent such a finding, the Administrator may not take action
under section 6(a).

This standard for taking action recognizes that factual certainty
respecting the existence of an unreasonable risk of a particular harm

1 1 may not be possible and the bill does not require it. Such uncertainty
is particularly likely to occur true when dealing with the long term
or chionic effects of a substance or mixture. For example, cancer does
not appear immediately after exposure to a carcinogenic substance or
mixture, but instead there may be a latency period of several years
before the cancer appears. With mutagens, the effects may not become
apparent until generations have passed. When, as here, regulatory
action is intended to be taken to prevent the occurrence of harm in the
future as well as protect against presently visible harm, such action
often must be based not only consideration of facts but also on consid-
eration of scientific theories, projections of trends from currently
available data, modeling using reasonable assumptions, and extrapo-
lations from limited data. Further, regulatory action may be taken
even though there are uncertainties as to the threshold levels of causa-
tion. Thus, the bill requires a reasonable basis to conclude that a sub-
stance or mixture causes or significantly contributes to or will cause,
or significantly contribute to an unreasonable risk to heaUh or envi-
ronment. Such a judgment may be based upon items such as toxico-
logical, physiological, epidemiological, biochemical, or statistical re-
search or studies or extrapolations therefrom. A finding by the
Administrator that there is such a reasonable basis must include ade-
quate reasons and explanations for the Administrator's conclusion. It
does not, however, require the factual certainty of a "finding of fact"
of the sort associated with adjudication.

(32)

440

The term "significantly contribute to an unreasonable risk" is used
throughout the bill. The Committee has used such term because it
recognizes that an individual substance or mixture may not be the sole
identifiable factor which may cause an unreasonable risk. Because
of the multiple avenues by which humans and the environment are ex-
posed to a substance or mixture and because substances and mixtures
do not occur in the environment in isolation, risks may result from
complex interactions or because of cumulative effects. Thus the bill
authorizes actions against a substance or mixture w^hich is only a con-
tributing factor to an unreasonable risk. The bill specifies that the
contribution be significant, for the Committee does not intend to au-
thorize action against a contributing factor which is only de minimus.
However, the Committee recognizes that in many instances it will be
impossible f(/r the Administrator to show^ the quantity of contribution
to a particular risk made by a particular substance or mixture, and the
Committee does not intend that the Administrator be required to do
so in such situations. Nor does the Administrator have to show that
a substance or mixture is the predominant contributing factor. Be-
cause of potential cumulative or synergivStic effects, even a small con-
tribution may be significant. Moreover, because of the dispersion and
transformation of chemical substances and mixtures in the environ-
ment, the substance or mixture may contribute to a risk indirectly
or directly. The considerations discussed in this paragraph would,
of course, applv whenever the phrase is used in the bill.

A section 6 (a ) rule may consist of any one or more of the follow-
ing: (1) a requirement prohibiting the manufacturing, processing,
or distribution in commerce of the substance or mixture or limiting
the amount of such substance or mixture which may be manufactured,
processed, or distributed in commerce; (2) a requirement prohibiting
the manufacture, processing, or distribution in commerce of the sub-
stance or mixture for a particular use or prohibiting the manufacture,
processing, or distribution in commerce of the substance or mixture
for a particular use in excess of a specified level of concentration; (3)
a requirement limiting the amount of tlie substance or mixture which
may be manufactured, proceSvSed, or distributed in commerce for a
particular use or a particular use in a concentration in excess of a spec-
ified level; (4) a requirement that the substance or mixture or any
article containing it be marked with or accompanied by appropriate
warnings and instructions; (5) a requirement that the manufacturers
and processors of the substance or mixture make and retain records
of the processes used to manufacture or process the substance or mix-
ture; (6) a requirement regulating the manner or method of disposal
of the substance, mixture or any article containing it by its manu-
facturer, processor, or by any commercial user; and (7) if a require-
ment described in clause (1), (2), or (3) is imposed, a requirement
that the manufacturers and processors of the substance or mixture
provide notice of the risk to persons hi possession of the substance or
mixture and to the public. The Committee recognizes the inherent in-
terests of the States and political subdivisions respecting disposal of
hazardous chemicals within their jurisdiction. As a result, the Com-
mittee has limited the Administrator to prescribing only those dis-
posal requirements which do not violate any law of a State or a po-

441

litical subdivision of a State. In addition, any disposal requirement
shall require persons subject to it to notify each State and political
subdivision in which a required disposal may occur.

While the bill authorizes the Administrator to prohibit or limit the
distribution in commerce of substances or mixtures and to prohibit
or limit the distribution in commerce of substances and mixtures for
a particular use, such authority does not authorize the Administrator
to regulate the manner or method of transporting hazardous chemical
substances or mixtures in commerce. For example, the loading, un-
loading, and storage in connection with transportation in commerce
are regulated under the Hazardous Materials Act of 1974, and it is
not the Committee's intent to grant the Administrator any regulatory
authority under section 6(a) with respect to such loading, unloading,
or storage.

The Committee recognizes that the requirements prescribed by the
Administrator under this section may provide protection for em-
ployees in the workplace. For example, by prohibiting the manufac-
ture of a substance, risks to employees involved in the manufacturing
of the substance would be eliminated. However, the Committee wishes
to emphasize that none of the authorities included in section 6(a)
should be construed as authorizing the Administrator to issue work-
place standards directly regulating such matters as the airborne con-
centrations of a substance to which employees may be exposed or the
manner in w^hich an employee is permitted to handle a substance.
There is no authority in the bill for the Administrator to issue rules
respecting personal protective equipment for employees, work prac-
tices in hazardous operations, or procedures for emergency situations.
Such direct regulation of the workplace falls under the jurisdiction
of the Occupational Safety and Health Act of 1970 not under this bill.

The Committee intends that any requirement prescribed under sec-
tion 6(a) be the least burdensome possible for those subject to the re-
quirement and for society while providing an adequate margin of
protection against the unreasonable risk. The Committee expects that
the determination of the least burdensome requirement will be based
on information submitted to the Administration during the rulemak-
ing proceeding and other information which is readily available to
the Administrator. The Committee does not intend that needed reg-
ulation be unreasonably delayed while the Administrator develops
quantative data comparing the costs of control methods. Because dif-
ferent environmental or health conditions in different areas of the
country may require different forms of regulation to protect against
an unreasonable risk, the bill permits a i^equirement to be limited in
application to specified geographic areas.

Protection against adulterated or contaminated substances and
mixtures

Subsection (b) of section 6 authorizes the Administrator to take
action to prevent the adulteration or contamination of substances and
mixtures. If the Administrator has good cause to believe that a par-
ticular manufacturer or processor is manufacturing or processing a
substance or mixture in a manner which unintentionally results in the
substance or mixture causing or significantly contributing to or to

79-313 O - 77 - 29

442

being likely to cause or significantly contribute to an unreasonable
risk, then the Administrator is authorized to take certain action. The
Administrator may by order require the submission of a description
of the relevant quality control procedures. Further, if after a hearing
in accordance with section 554 of title 5, United States Code, the
Administrator determines on the record that the quality control
procedures are inadequate, the Administrator may order the revi-
sion of the quality control procedures. In addition, if the Admin-
istrator determines that the inadequate procedures have resulted
in the distribution of a chemical substance or mixture which causes
or significantly contributes to an unreasonable risk, the Administrator
may require the person subject to the order to provide notice of the
risk associated w^th the substance or mixture and to replace or
repurchase any substance or mixture produced under the defective
quality control procedure as is necessary to protect health or environ-
ment.

Considerations iii promulgating section 6 (a) rules

Section 6(c) requires the Administrator to consider all relevant
factors in promulgating any rule under subsection (a) respecting a
substance or mixture. Findings must be made with respect to the effects
of the substance or mixture on health and the magnitude of human ex-
posure to the substance or mixture, the effects of the substance or mix-
ture on the environment and the magnitude of environmental exposure,
the benefits of the substance or mixture for various uses and the avail-
ability of other substances or mixtures for such uses, and the reason-
ably ascertainable economic consequences of the rule taking into
account the impact on small business. In making the finding respecting
the reasonably ascertainable economic consequences, the Committee
anticipates that the Administrator's consideration will include, but
not be limited to, major effects of the rule on the national economy
and the rule's effect on technological innovation, the environment, and
the public health. Of course, because basic information regarding
economic eflf'ects on the regulated industry is within the particular
expertise of the industry, the Committee expects the industry
to come forward with such data. The economic consequences of a rule
should include the positive impact a regulatory limitation or proscrip-
tion will have on the development and use of substitutes as well as the
negative impact on the manufacturer or processor of the regulated
substance. Likewise, the economic savings to society resulting from the
removal of an unreasonable risk must be a key element in any consid-
eration of economic consequences. The Committee does not intend that
a chemical which causes or significantly contributes to an unreason-
able risk should be permitted to be marketed solely because it would
cause economic costs to producers if it were not permitted to be sold.

An additional finding is required if the Administrator determines
that the risk to health or the environment could have been eliminated
or reduced to a sufficient extent by actions taken under another Fed-
eral law administered in whole or in part by the Administrator. In
such a situation, the Administrator must make a finding that it is in
the public interest to take action under the bill rather than under such
other Federal law. The fact that a risk could be subject to regulation

443

under one of the other Federal laws administered by the Administrator
does not trigger the additional finding requirement. Instead, the Ad-
ministrator must determine that the risk could be eliminated or re-
duced to a sufficient extent under the other law before the finding is
required. It is particularly appropriate that this initial decision be
vested in the Administrator since the determination involves Acts
administered by the Administrator and thus is clearly within the
expertise of the xVdministrator. In making the finding, the Admin-
istrator is to take into consideration all aspects of the risk, the authori-
ties available to enforce actions under the Toxic Substances Con-
trol Act and such other laws, a comparison of the estimated costs
of complying, and the relative efficiency of actions under the respec-
tive laws. The consideration of comparative costs of complying with
action under this bill and under other laws should be based upon
information readily available to the Administrator. Consideration of
the relative efficiency of actions under this Act and under other laws
should include consideration of the time and resources needed to take
such actions.

The purpose of the Committee in requiring "findings" wnth respect
to the considerations listed in subparagraphs (A), (B), (C), and (D)
of subsection (c) (1) is to assure that the basis for the Administra-
tor's rule is publicly enumerated. Section 553 of title 5, United States
Code, which would otherwise solely govern the promulgation of such
a rule, requires that an agency incorporate in any rule adopted a con-
cise general statement of its basis and purpose. By requiring such find-
ings, the Committee is emphasizing that those key considerations
enumerated in subparagraphs (A), (B), (C), and (D) of subsection
(c) (1) will be addressed in such a statement of basis and purpose. The
findings need not be detailed or voluminous, nor does the Committee
expect the findings to be based solely on factual evidence. The Com-
mittee recognizes that, particularly with respect to such issues as the
effects of a substance or mixture on health or the environment, the
Administrator's findings may necessarily deal with projections from
imperfect data, experiments and simulations, educated predictions,
differing assessments of possible risks, etc. The findings are to be
issued at the time the rule under subsection (a) is promulgated, and
there will not be any judicial review of such findings separate and
apart from the review of the rule issued under section 6(a).

Procedures fcn^ promulgating section 6(a) rules

Rules under section 6(a) are to be promulgated pursuant to the
procedures of section 553 of title 5 of the United States Code, except
that the Administrator is required to give interested persons an op-
portunity for the oral presentation of data, views, or arguments, and
in certain instances an opportunity for cross-examination must be
provided.

If the Administrator determines that it is necessary to resolve dis-
puted issues of material fact, then an interested person is entitled to
conduct or have conducted by the Administrator such cross-examina-
tion as the Administrator determines (1) to be appropriate in view
of any need for expedition in the rulemaking proceeding, the nature
of the issues involved, the number of participants and the nature of

til

444

their interests, and (2) to be required for a full and true disclosure
with respect to disputed issues of material fact. By limiting the cross-
examination to disputed issues of material fact, the Committee intends
to limit cross-examination to those issues characterized as issues of
adjudicative fact the truth or falsity of which is subject to evidentiary
proof and which could reasonably be expected to affect the outcome of
the rule. The burden of showing that any issue is a "disputed issue of
material fact" rests on the person seeking to engage in cross-
examination.

In view of the large number of persons who may be interested in a
rulemaking proceeding, the Committee felt it was necessary to give
the Administrator the express authority to group, for cross-examina-
tion purposes, persons with the same or similar interests and provide
for their representation by a single representative. Further, the Ad-
ministrator may determine to conduct such cross-examination on be-
half of such a group. If a person who is a member of a group is unable
to agree upon group representation, the person shall not be denied the
opportunity to conduct or have conducted cross-examination as to
issues affecting the person's particular interest if the person satisfies
the Administrator that the person made a good faith effort to agree
upon group representation and if the Administrator determines that
there are substantial and relevant issues which are not adequately pre-
sented by the group representative.

It was the judgment of the Committee that more effective, workable
and meaningful rules will be promulgated if interested persons do have
the opportunity to make oral presentations, and where appropriate
and necessary, have an opportunity to conduct cross-examination and
present rebuttal evidence. However, it is not the Committee's intent
to create a cumbersome, timeconsuming administrative procedure
which will delay necessary regulation. Thus, not only does the Com-
mittee limit the instances in which cross-examination is required to
those in which the Administrator determines that it is necessary and
appropriate, but also the Committee authorizes the Administrator to
issue procedural rules for the conduct of oral presentations (including
cross-examination) and to impose time limits on such presentations as
may be appropriate in view of any need for expedition, the nature of
the issues involved, and the number of participants and the nature of
their interests.

In order to provide to the extent possible that all relevant interests
be represented in rulemaking proceedings so that the rules adopted
best serve the public interest, the Administrator is authorized to pro-
vide compensation for reasonable attorneys' fees, expert witness fees,
and other costs of participating: in the rulemaking proceeding. Such
fees and costs may be provided to any person who represents an in-
terest which will substantially contribute to a fair determination of
the issues to be resolved in the proceeding if the economic interest of
the person is small in comparison to the costs of effective participation
by that person in the proceeding or if the person demonstiates to the
satisfaction of the Administrator that the person does not have suffi-
cient resources to participate in the proceeding in the absence of com-
pensation. In determining if a person represents an interest which will
substantially contribute to a fair determination of the issues, the Ad-

445

ministrator is to take into account the number and complexity of the
issues and whether representation of such interest will contribute to
widespread public participation and to representation of a fair bal-
ance of interests for the resolution of the issues.

In determining whether compensation should be provided and the
amount of such compensation, the Administrator shall take into ac-
count the financial burden which will be incurred as a result of partic-
ipation. However, the Committee does not intend to imply that in all
instances a person must be able to demonstrate a financial burden
before the Administrator may provide the pereon with compensation.
Demonstration of financial burden is required unless a person has an
economic interest which is small in comparison to the costs of effective
participation in the proceeding. Thus when the economic interest is
small, no showing of financial burden is required. However, in light
of the possibility that there may be competing requests for assistance
in connection with proceedings under this section, a consideration of
financial burden will be relevant in determining who should be the
recipients of compensation and the amount of compensation. In con-
sidering the financial burden to be incurred, .the Administrator should
not look solely at the costs of participating in the section 6 proceed-
ing, but should instead view such costs in light of the overall activities
of the person applying for compensation and the person's resources.
For example, a person requesting compensation could show that such
person represents interests which may require participation in other
judicial or administrative proceedings and that such participation
might have to be curtailed or limited because of a commitment of re-
sources to the proceeding with respect to which such request made and
the Administrator should consider such information.

A determination of reasonable attorneys' and expert witnesses' fees
should not be influenced by the fact that a person is a salaried em-
ployee of a public interest or foundation funded organization. The
Committee intends that reasonable fees be those which are commen-
surate with those at which such professionals would normally be com-
pensated for performance of similar services. The fact that attorneys
or experts may be employed by citizens' groups or foundations at
salaries or hourly rates which may be below the standard commercial
rates such professionals might normally receive is not relevant to any
computation of the rate of compensation under the bill. Even in situa-
tions where a laAvyer or expert initially renders services without ex-
pectation of receiving any compensation, fees are to be awarded at
prevailing market rates. It may well be that an attorney will agree
to provide representation of an interest in a proceeding because of a
belief that such representation furthers a public interest. Representa-
tion of such interests should not have to rely upon the charity of
counsel. This intent reflects the well-settled judicial rule that fee
awards are to be made without reference to the fee arrangements that
exist between an attorney and client. As the court stated in Miller v.
Amusement Enterprises, Inc., 426 F. 2d 532, 538-539 (5th Cir. 1970) :

What is required is not an obligation to pay attorneys' fees.
Rather what — and all — that is required is the existence of a
relationship of attorney and client, a status which exists
wholly independently of 'compensation.

446

Similarly, the United States Court of Appeals for the District of
Columbia Circuit has ruled that fee awards in litigation undertaken
to further the public interest must be computed so as to bring the
attorneys' rate of compensation up to that of the prevailing market
rate. See Wilderness Society v. Morton, 495 F. 2d 1026, 1037 (D.C.
Cir. 1974) , reversed on other grounds, sub nom. Alyeska Pipeline Co. v.
Wilderness Society, 421 U.S. 240 (1975), and National Treasury Em-
ployees V. Nixon, 521 F. 2d 317, (1975). Provision is made in section
19 (judicial review), section 20 (citizens' civil action), and section 21
(citizens' petition) for the award of reasonable attorneys' and expert
witnesses' fees in actions under such sections. The considerations
enumerated here respecting a determination of the reasonableness of
a fee also apply to those sections.

Effective date of section 6 (a) ndes

Subsection (d) states that the Administrator is to specify in any
rule under subsection (a) the date on which it shall take effect. Such
effective date is to be as soon as feasible. In certain circumstances a
proposed rule may be declared effective immediately upon its publica-
tion in the Federal Register. If the Administrator determines that the
manufacture, processing, distribution in commerce, use, or disposal of
a substance or mixture subject to the proposed rule is likely to result
in an unreasonable risk of serious or widespread harm to health or the
environment before such effective date and that making the proposed
rule immediately effective is necessary to protect the public interest,
then the Administrator may declare the rule effective immediately
upon its publication in the Federal Register. However, if the proposed
rule would prohibit the manufacture, processing, or distribution of
a substance or mixture, a court must have first granted relief in an
action under section 7 with respect to the risk before the Administra-
tor may make a rule prohibiting the manyfacture, processing or
distribution of a substance or mixture immediately effective. It is
because of the severity of a rule which prohibits the manufacture,
processing, or distribution in commerce of a substance or mixture, that
the Committee required an action be brought under section 7
(imminent hazard) to have a Federal district court find that the sub-
stance or mixture is an imminent hazard. However, because the Com-
mittee recognizes the difficulties in bringing such an action against all
persons who may be engaged in the manufacture, processing, or dis-
tribution of a substance or mixture, the Committee has required that
such an action be brought against only one such person under section
7 or that the Administrator have brought an in rem action against a
substance, mixture, or article under section 7. Once a court finds an im-
minent hazard in the action under section 7, a banning rule of general
applicability may then be made immediately effective with respect to
all others.

If a proposed rule is made immediately effective, the Administrator
must expeditiously provide for an opportunity for a hearing on the
rule. If a hearing is requested, the Administrator shall commence the
hearing within five days from the date of receipt of the request for the
hearing, unless the Administrator and the person making the request
agree upon a later date. The hearing must be conducted in accordance

447

with the procedures set out in subsection (c) (2) and (c) (3). After the
hearing is concluded, the Administrator must within ten days, either
affirm, modify, or revoke the rule.

SECTION 7, IMMINENT HAZARD

Section 7(a) grants the Administrator authority to bring a district
court action for seizure of an imminently hazardous chemical sub-
stance, mixture, or article containing such substance or mixture. Ac-
tions are also authorized against any person who manufactures, proc-
esses, or distributes in commerce an imminently hazardous chemical
substance, mixture, or article.

If the Administrator has not used the authority provided in section
6(d) (2) (A) (i) to make a section 6(a) rule immediately effective in
order to protect against an imminently hazardous chemical substance,
mixture, or article, the Administrator must bring an action under sec-
tion 7. The Committee has required such action in order to insure that
protection is provided against imminently hazardous substances, mix-
tures, and articles. Of course, there may be instances in which the
Administrator may put a rule into effect immediately under section
6(d) (2) (A) (i) and will also bring an action under section 7 in order
to obtain the forms of relief available under section 7 which are not
available under section 6. For example, section 7 authorizes the seizure
of imminently hazardous substances, mixtures, or articles containing
them, and under section 7 the court may require the recall, repurchase,
or replacement of imminently hazardous items in addition to any
other relief necessary to protect health or the environment.

Subsection (b) gives the United States district courts jurisdiction
to grant such temporary or permanent relief as may be necessary to
protect health or the environment from the imminent hazard. Such
relief may include a requirement that manufacturers, processors, or
distributors provide notice of the risk to the public and to any known
purchasers, recall, and replace or repurchase the substance, mixture,
or article. Seizure and condemnation of the substance, mixture, or
article is authorized.

Subsection (c) relates to venue, service of process, and consolidation.

Subsection (d) provides that where appropriate, the Administrator
shall initiate a proceeding for the promulgation of a rule under sec-
tion 6(a) concurrently with the filing of an action under this section.

Under subsection (e) the Administrator may direct attorneys of the
Environmental Protection Agency to appear and represent the Ad-
ministrator in any action under this section.

Subsection (f) defines the term "imminently hazardous chemical
substance or mixture''. The term means any chemical substance or mix-
ture which causes or significantly contributes to an imminent and un-
reasonable risk of serious or widespread harm to health or the en-
vironment. Such a risk shall be considered imminent if it is shown that
the manufacture, processing, distribution in commerce, use, or disposal
of the substance or mixture or any combination of such actions is likely
to result in such harm to health or the environment before a final rule
under section 6 can protect against the risk. Such protection would
not necessarily occur upon the effective date of a rule under section 6.

448

Instead, consideration must be given to the time it may take to im-
plement and enforce such a rule.

It should be noted that while the unreasonable risk of harm must
be imminent, the physical manifestations of the harm itself need not
be. An imminent hazard may be found at any point in the chain of
events which may ultimately result in damage to the health or environ-
ment. The observance of harm is not essential to establish that an im-
minent hazard of such occurrence exists. Obviously, action under the
section must be able to occur early enough to prevent the final injury
from materializing.

SECTIOX 8, REPORTING AND RETENTION OF INFORMATION

Subsection (a) of section 8 authorizes the Administrator to promul-
gate rules under which each person (other than a small manufacturer
or processor) who manufactures or processes or proposes to manufac-
ture or process a chemical substance shall maintain such records and
submit such reports to the Administrator as the Administrator may
reasonably require. The Administrator also is authorized to promul-
gate rules under which manufacturers and processors (other than
small manufacturers and processors) of mixtures shall maintain rec-
ords and submit reports, but only to the extent the Administrator de-
termines is necessary for the effective enforcement of the bill. The au-
thority to require the maintenance of records and submission of re-
ports by manufacturers of chemical substances in small (quantities
solely for scientific experimentation or analysis or for chemical re-
search or analysis on such substance or another substance is similarly
limited to reports and records necessary for the effective enforcement
of the bill. The Committee has specified a different standard for re-
quiring reporting for manufacturers or processors of mixtures and
research substances because the Committee anticipates that in imple-
menting its regulatory functions the need for information from such
manufacturers and processors will not be as great as it will be with
respect to other manufacturers or processors.

As a further limitation, section 8(a) (1) (A) specifies that the Ad-
ministrator may not require the maintenance of records or the sub-
mission of reports with respect to changes in the proportions of the
components of a mixture unless the Administrator finds that such
recordkeeping or reporting is necessary for the effective enforcement
of the bill. A mixture manufacturer may make an infinite number of
changes in the proportions of substances comprising a mixture, and
the Committee wishes to protect such manufacturers from having to
document of all such changes unless such changes could affect health or
the environment. In most instances, the information relevant for
the Administrator for the enforcement of the bill will be the par-
ticular substances used in a mixture and the range of proportions.
Documentation of each specific alteration in proportion would in
most instances be unnecessarily burdensome and have little relevance
to the effective enforcement of the bill.

The Administrator must promulgate rules to obtain the informa-
tion necessary to compile the list of existing chemical substances re-

449

uired under subsection (b) not later than one hundred and eighty
ays after the effective date of the bill.

i^aragraph (2) of subsection (a) provides examples of the kinds
of information which the Administrator may require to be reported.
Included are the common or trade names, chemical identity, and
molecular structure insofar as known to the person making the re-
port or insofar as reasonably ascertainable ; the categories or proposed
categories of use, insofar as known to the person making the report
or insofar as reasonably ascertainable; reasonable estimates of the
amount of each substance and mixture to be manufactured or proc-
essed and, insofar as known to the person making the report or in-
sofar as reasonably ascertainable, a reasonable estimate of the amount
of the substance or mixture to be manufactured or processed for each
category or proposed category of use ; a description of the byproducts
resulting from the manufacture, processing, use, or disposal, inso-
far as known to the person making the report or insofar as reasonably
ascertainable ; all existing data concerning the adverse environmental
and health effects of such substance or mixture, insofar as known to the
person making the report; and estimates of the number of persons who
will be exposed to the substance or mixture in work places and the dura-
tion of such exposure, insofar as known to the person making the
report. Information should be considered reasonably ascertainable if
the manufacturer or processor required to obtain the information can
do so without incurring unreasonable costs or burdens.

To the extent feasible, the Administrator shall not require unneces-
sary or duplicative reporting. The Committee realizes that record-
keeping and reporting may be a time-consuming and resource-consum-
ing undertaking. tJnder section 3503 of title 44 of the United States
Code (the Federal Reports Act), the Office of Management and
Budget is required to review the collection of information required
by the Environmental Protection Agency to assure that such infor-
mation is obtained with a minimum of burden on business enterprises
and other persons and that unnecessary duplication is avoided. The
Committee intends that every effort be made to realize this objective.
For instance, where information respecting the chemical identity and
molecular structure of chemicals comprising a mixture is obtained
from the manufacturers of the chemical components, it would be dup-
licative for the Administrator to require similar reporting from the
mixture manufacturer, and should if feasible be avoided. Further,
every effort should be made to utilize information reasonably avail-
able from other Federal entities rather than seeking the same infor-
mation from manufacturers and processors.

The Administrator should consider the vast size of the chemical in-
dustry in developing proposed rules for reporting. There are approxi-
mately 1,000 companies in the basic chemical industry. In addition,
there are 3,100 allied establishments and another 7,400 companies
which process chemical substances and mixtures. Clearly, indiscrimi-
nate reporting: requirements could result in an inundation of unneces-
sary and duplicative information.

Because reporting and recordkeeping requirements under section 8
(a) may impose a particularly heavy burden on small manufacturers
or processors, the Committee bill provides an exemption from such

450

reporting and recordkeeping for small manufacturers and processors.
However, the Administrator may by rule require a small manufacturer
or processor of a chemical substance to submit information respecting
the substance to the Administrator for purposes of compiling the in-
ventory of existing chemical substances required under section 8(b).
In addition, the Administrator may by rule require small manufac-
turers or processors of a chemical substance or mixture subject to a
proposed rule or a final rule under sections 4, 5(g), 5(c), or 6 to
maintain records and submit reports on such substance or mixture. In
addition, if relief has been granted in an imminent hazard proceeding
under section 7 with respect to a substance or mixture, the Adminis-
trator may by rule require a small manufacturer or processor of the
substance or mixture to maintain records and submit reports on the
substance or mixture. Thus, reporting and recordkeeping by small
manufacturers and processors is to be held to a minimum. At the same
time the Administrator will not be denied information necessary for
determining whether to promulgate a rule under sections 4, 5, or 6 or
necessary for the enforcement of such a rule or an order issued in an
action brought under section 7.

The Administrator, after consultation with the Small Business Ad-
ministration, shall by rule prescribe standards for determining what
manufacturers and processors will be considered "small" manufac-
turers and processors. In prescribing such standards, the Committee
anticipates that the Administrator will take into account such relevant
factors as the number of employees, the resources reasonably available
for recordkeeping or reporting, the volume of production of sub-
stances and mixtures for which reporting or recordkeeping may be
required in relation to the volume of such production by others, and
whether a company is independently owned and operated. In the case
of a company which is owned or controlled by another company, such
factors are to be applied to both companies.

Subsection (b) requires the Administrator to compile, keep current,
and publish an inventory of existing chemical substances manufac-
tured or processed for commercial purposes in the United States. The
inventory is to be used by manufacturers and processors to determine
if a chemical substance is a "new" substance subject to the premarket
notification requirements of section 5. The Administrator is to initially
publish the inventory within one year after the effective date of the
bill.

Subsection (b) provides that the inventory shall at least include eaxjh
chemical substance which any person reports under section 5 or under
section 8(a) is manufactured or processed in the United States or was
manufactured or processed in the United States within three years be-
fore the effective date of the rules promulgated under section 8(a) for
purposes of compiling the subsection (b) inventory. However, the Ad-
ministrator, to alleviate reporting requirements and expedite the com-
pilation of the initial list, may wish to utilize reports of commercially
produced chemical substances prepared by other governmental offices
and departments, such as the International Trade Commission and the
Bureau of Mines. However, the Administrator may not rely exclusive-
ly upon such reports, but must give manufacturers and processors the

451

)pportunity to report substances manufa^ctured or processed for com-
nercial purposes which are not included within such reports.

In submitting reports with respect to existing chemical substances
vhich the Administrator will use in compiling the inventory, a manu-
•acturer may report substances whicii are produced only intermittently
)ut which are a part of the manufacturer's product line. Many manu-
iacturers, particularly those who produce in batch lots, may not be
;urrently producing the full range of substances they customarily offer.
Flowever, so long as the manufacturer has produced the substance for
commercial purposes within the three year period described in section
^ (b) ( 1 ) , the manufacturer should repoil the substance and it should be
ncluded in the inventory.

Ptira;i,iaph 'J^ oi subj^iictiv ii (b) provides that to the extent consistent
^'ith the purposes of this bill, the Administrator may in compiling and
naintaining the inventory, list a category of chemical substances
'ather than list individually each chemical substance within the cate-
rory. By listing a category of chemical substances, minor modifica-
;ions or variations in the formulation or structure of a chemical sub-
stance which would have insignificant health or environmental con-
sequences would not automatically be subject to the notification re-
quirements of section 5. For instance, the Administrator could use cate-
;^ories so that reporting would not be required as a result of changes
3uch as the following: polymers or co-polymers which vary only in
:he proportion of starting materials or catalysts used, or in molecular
weight, molecular weight distribution, chain structure or crystallinity ;
:hanges within an existing chemical substance in the proportions of
colorants, stabilizers, antioxidants, fillers, solvents, carriers, surfac-
tants, plasticizers, and other adjuvants which are themselves reported
is existing substances ; variations in the proportion of alloyed metals
in iron and steel products and other metal alloys ; variations in natu-
rally occurring substances or mixtures (such as crude oil, natural gas,
minerals, or ores) and the resulting variations in extracts or refined
products therefrom; variations in reported reactive mixtures whose
conmiercial or end-use product is electric energy (batteries) ; and salts
which result from the combination of an existing inorganic anion
with an existing inorganic cation.

The Committee realizes that many chemical companies, particularly
small ones, are able to compete in the chemical industry only by con-
tinually reformulating or making slight changes in existing chemical
substances. It would be extremely burdensome on them as wxll as on
the Administrator if every insignificant change were subject to the
premarket notification requirements of section 5. By using categories
in the inventory, the Administrator will be able to minimize such
burdens. However, the Committee also realizes that minor modifica-
tions of innocuous compounds may produce highly toxic chemicals.
Thus, the use of categories should be limited to areas where the effects
of such minor modifications are well understood to have insignificant
health and environmental consequences.

Subsection (c) specifies that any person who manufactures or proc-
esses or distributes in commerce a cl emical substance or mixture or
proposes to engage in such an activity shall, as required by the Admin-
istrator by rule, maintain records of adverse reactions to health or the

452

environment alleged to have been caused by the substance or mixture.
The Administrator may require that records relating to the alleged
adverse reactions to the health of employees be retained for up to fifty
years, and that other records be retained for up to five years. Upon
request, each person who is re;^uired to maintain such records
shall permit inspection of the records and submit copies to the
Administrator.

Subsection (d) authorizes the Administrator to promulgate rules
requiring persons who manufacture, process, or distribute in com-
merce or who propose to manufacture, process, or distribute in com-
merce a chemical substance or mixture to submit lists of health and
safety studies conducted or initiated by or for such person or known to
such person, and to submit copies of such studies. In addition, the
Administrator may by rule require any person who has possession of
such a study to submit copies of the study to the Administrator.

Subsection (e) requires any person who manufactures, processes, or
distributes in commerce a chemical substance or mixture to immedi-
ately inform the Administrator of any information which reasonably
supports the conclusion that the substance or mixture causes or sig-
nificantly contributes to a substantial risk to health or the environ-
ment. However, if the person has actual knowledge that the Adminis-
trator has aheady been adequately informed of, the information,
notification of the Administrator is not required. The requirement of
subsection (e) is to insure by statute that the Administrator is immedi-
ately informed of such information, and it is not intended to limit
the authority of the Administrator under subsection (a) to require
reporting of data concerning the adverse environmental and health
effects of a substance or mixture.

Subsection (f) specifies that for purposes of section 8, the terms
"manufacture" and "process" mean manufacture or process for com-
mercial purposes. Section 3(7) defines "manufacture" to mean "im-
port, produce, or manufacture". Thus the provisions of section 8 apply
to persons who manufacture, process, or import chemical substances or
mixtures solely for commercial purposes.

SECTION 9, REI^TIONSHIP TO OTHER FEDERAL LAWS

Because other Federal laws to some extent provide for regulation of
toxic chemicals, it is necessary to define the relationship between the
regulatory authority of this bill and that provided under other Fed-
eral laws. It is the intent of the Committee that any overlapping or
duplicator^ regulation he avoided while providing for the fullest pos-
sible measure of protection to health and the environment.

Section 9(a) sets out the relationship between the bill and other
Federal laws not administered by the Administrator. If the Adminis-
trator has reason to believe that the manufacture, processing, distri-
bution in commerce, use, or disposal of a chemical substance or
mixture (or any combination of such activities) causes or signifi-
cantly contributes to or is likely to cause or significantly con-
tribute to an unreasonable risk and if the Administrator determines
that such risk may be prevented or reduced to a sufficient extent by
action taken under a Federal law not administered by the Administra-

453

tor, then the Administrator is required to report to the agency which
administers such law a description of such risk. Such description shall
include a specification of the activity or combination of activities
which the Administrator has reason to believe so causes or contributes
to such risk. The report shall include a detailed statement of the
information on which it is based, shall be published in the Federal
Register, and shall request the agency to which it is made —

(1) To determine if the risk described in the report may be
prevented or sufficiently reduced by action taken under its law,
and

(2) If it determines it may be so prevented or reduced, to issue
an order declaring whether or not the activity specified in the
report causes or significantly contributes to such risk.

The agency receiving the request from the Administrator shall issue
the requested order and determination within such time as the Admin-
istrator specifies in the request. However, the Administrator must give
the other agency at least ninety days.

If the other agency takes one of two alternative courses of actions
specified in section 9(a)(2), then the Administrator is barred from
acting under section 6 or 7 with respect to the risk about which the
Administrator notified the other agency. First, if the other agency
issues an order declaring that the activity specified in the report does
not cause or significantly contribute to the risk described in the report,
the Administrator may not take any action under section 6 or 7 with
lespectto such risk. Alternatively, if within ninety days of the publi-
cation in the Federal Register of the other agency's response to the
Administrator's request, the other agency initiates action under its
law which is adeqtiate to protect against such risk, the Administrator
is precluded from taking any action under section 6 or 7 with respect
to such risk.

The requirement that the other agency initiate action is not intended
to indicate that formal action by the other agency be undertaken
within the specified time period, for time constraints may preclude
any formal regulatory actions within such period. So long as the other
agency has officially initiated an action which will culminate as soon
as practicable in effective regulatory action to protect against the un-
reasonable risk and sets forth a general time schedule of steps for
such action, the requirements of section 9(a) (2) (B) should be deemed
satisfied. However, the provisions of section 9(a)(2)(B) would not
be satisfied by the merely open-ended possibility of action by the other
agency.

Subsection (b) indicates the relationship between the bill and other
law administered in whole or in part by the Administrator. Under
subsection (b) if a risk to health or the environment associated with
a chemical substance or mixture could be eliminated or reduced to a
sufficient extent by actions taken under the authorities contained in
another Federal law administered by the Administrator, the Admin-
istrator is required to use the other law unless the Administrator de-
termines that it is in the public interest to protect against the risk
by taking action under the bill.

Other laws administered by the Administrator mandate specific
actions by the Administrator. For instance, the Federal Water Pol-

454

lution Control Act establishes a specific timetable within which the
Administrator is to establish eftiuent limitations, list categories of
sources, and establish standards of performance for new sources within
such categories. The Committee wishes to emphasize that nothing in
the bill should be construed to relieve the Administrator from com-
plying with any such statutory mandates.

Subsection (c) provides that for purposes of section 4(b)(1) of
the Occupational Safety and Health Act of 1970, the Administrator in
exercising any authority under the bill shall not be deemed to be
exercising statutory authority to prescribe or enforce standards or
regulations affecting occupational safety and health. Consequently
authorities granted under the bill will not preempt action under such
Act.

Subsection (d) requires the Administrator to consult and coordi-
nate with the Secretary of Health, Education^ and Welfare and the
heads of other appropriate Federal departments, agencies, and instru-
mentalities in order to achieve the maximum enforcement of the bill
while imposing the least burden of duplication. The Administrator
must report annually to the Congress on actions taken to coordinate
with other Federal departments, agencies, and instrumentalities and
on actions taken to coordinate the authority under the bill with au-
thority granted under other laws administered by the Administrator.

SECTION 10, RESEARCH, COLLECTIOX, DISSEMIXATIOX, AND UTILIZATION

OF DATA

Section 10(a) requires the Administrator, in consultation and coop-
eration with the Secretar^^ of Health, Education, and Welfare and
heads of other appropriate departments and agencies to conduct such
research and monitoring as is necessary to carry out the purposes of
tlie bill. The Committee has required consultation and cooperation
with other agencies and departments in order to insure that the Ad-
ministrator does not duplicate the efforts of other agencies in conduct-
ing research under the bill. Such duplication should be avoided both
in research conducted by the Administrator as Avell as in research con-
ducted pursuant to contracts entered into by the Administrator.

Section 10(b) requires the Administrator to establish and coordi-
nate the activities of an interagency committee to design, establish,
and coordinate a system for the collection, dissemination, and use of
data submitted to the Administrator. The Administrator is to estab-
lish and coordinate a retrieval system for toxicological and other sci-
entific data which could be useful to the Administrator in carrying
out the purposes of the bill. The system shall be developed for use by
all Federal and other departments and agencies with responsibilities
in the area of regulation or study of chemical substances and mixtures
and their effects on health or the enviromnent. The Committee expects
that in developing the retrieval system the Administrator will utilize
existing Federal data systems to the fullest extent possible.

Presently the collection of data on chemicals which may be harmful
is fragmented among several Federal departments and agencies. The
Committer* feels that there is an urgent need for the development
of a systematic bank of information which can be queried by any

455

regulatory agency faced with a problem respecting a substance or
mixture or by any agency or department interested in research on
a substance or mixture. One of the major problems confronting regu-
latory agencies is the uncertainties regarding the total exposure of
humans or the environment to a chemical substance or mixture. Ex-
posure to a chemical may come simultaneously from several different
sources or through two or more media. As pointed out by the National
Academy of Sciences in its report, Decision Making for Regulating
Chemicals in the Environment^ it is essential that each agency's stand-
ards reflect appreciation of such multiple exposures.^ The develop-
ment of a comprehensive data system should help make this possible.

SECTIOX 11, INSPECTIONS

Subsection (a) authorizes the Administrator or a duly designated
representative to conduct inspections for the purposes of enforcing
the bill or any rule or order promulgated under the bill. Inspections
are authorized of any establishment, facility, or other premise in
which chemical substances or mixtures are manufactured, processed,
stored, or held before or after distribution in commerce and of any
conveyance used to transport a substance or mixture in connection
with its distribution in commerce. An inspection may be made only
upon presenting appropriate credentials and a written notice to the
owner, operator, or agent in charge of the premises or conveyance to
be inspected. Separate notices must be given for each inspection, but
not for each entry made during the period covered by an inspection.
Inspections are to be commenced and completed with reasonable
promptness and shall be conducted at reasonable times, within reason-
able limits, and in a reasonable manner.

Subsection (b) sets out the scope of the inspections. An inspection
shall extend to all things within the premises or conveyance bearing
on whether the requirements of tlie bill have been complied with.
However, no inspection may extend to financial data, sales data other
than shipment data, pricing data, personnel data, or research data
(other than research data required by this Act), unless the nature
and extent of sucK data are described with reasonable specificity in
the written notice.

SECTION 1 2, EXPORTS

Subsection (a) of section 12 provides that with certain exceptions
this bill (other than section 8 (relating to reporting and recordkeep-
ing)) shall not apply to anv chemical substance, mixture, or article
containing a substance or mixture if it can be shown that such chemi-
cal substance, mixture, or article is being manufactured, processed,
sold, or held for sale, for export from the^ United States, unless such
chemical substance, mixture or article was, in fact, manufactured,
processed, sold, or held for sale, for use in the Ignited States. Thus, for
example, a manufacturer facing an enforcement proceeding for manu-
facturing a substance for domestic use in violation of the bill could

i Decjsion Mailing for Reqnlating Chemicals in the Enviroyiment, Committee on Prln-
«f of Decision Making for Reernlatinjr Chemicals in the Environment. Environmental
atnaies Board. CommisBion on Natural Resources. National Research Council, National
Academy of Sciences, p. 39 (July 1975).

456

not claim the benefits of the exemption under this section in order
to export the noncomplying substance.

In order to qualify. for the export exemption, a chemical substance,
mixture, or article or container in which it is enclosed when distri-
buted in commerce must bear a stamp or label stating that it is in-
tended for export.

The export exemption shall not apply to any chemical substance,
mixture, or article if the Administrator finds that it will cause or
significantly contribute to an unreasonable risk to health within the
United States or to the environment of the United States. The Ad-
ministrator may require testing: under section 4 of an otherwise ex-
empt chemical substance or mixture to determine whether it causes
or significantly contributes to an unreasonable risk to health within
the United States or to the environment of the United States.

Subsection (b) provides that if any person exports or intends to
export to a foreign country a chemical substance or mixture for which
(1) the submission of data is required under section 4 or 5(d), (2)
a rule has been proposed or promulgated under sections 5 or 6, or (3)
an action is pending or relief has been granted under section 7, the
person shall notify the Administrator. The Administrator must fur-
nish to the government of the country of destination timely notice of
the availability of data submitted under section 4 or 5 or of the
rule, action, or relief under section 5, 6, or 7.

SECTION 13, ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES

Subsection (a) provides that the Secretary of the Treasury is to
refuse entry into the United States of any chemical substance, mixture,
or article containing such substance or mixture if it fails to comply
with any rule in effect under the bill, or if it is offered for entry in vio-
lation of section 5, a rule or an order under section 5 or 6, or an order is-
sued in an action under section 5 or section 7. The Secretary of the
Treasury is required to notify the consignee of any chemical substance,
mixture or article which is refused entry. The Secretary is to cause its
disposal or storage if it has not been exported within 90 days from the
date the consignee receives notice of refusal of entry. Of course, the
Committee intends that the Secretary consult with the Administrator
prior to taking such action. The Secretary may not release to the con-
signee any substance, mixture, or article refused entry, except the Sec-
retary may, pending a review by the Administrator of the entry
refusal, release the substance, mixture or article to the consignee on
execution of bond for the amount of the full invoice of the substance,
mixture or article together with the duty thereon. The consignee shall
be liable to the United States for liquidated damages equal to the full
amount of the bond if the substance, mixture or article is not returned
to the custody of the Secretary of the Treasury when demanded. The
Secretary. of the Treasury, after consultation with the Administrator,
is to issue rules for the enforcement of this section.

SECTION 14, DISCLOSURE OF DATA

In order to insure that the Administrator have full and complete
access to information relevant to achieving the objectives of the bill,

457

H.R. 14032 gives the Administrator broad information gathering
authority. However, the Committee recognizes that some information
which the Administrator may obtain will be of tremendous competi-
tive value to the person providing it. Accordingly, section 14 contains
specific prohibitions against release of such information so that the
competitive position of those supplying the information will be
protected.

Except for certain authorized disclosures, subsection (a) prohibits
the Administrator or any representative of the Administrator from
disclosing any information reported to or otherwise obtained under
this bill which is exempt from disclosure under section 552 of title 5
of the United States Code (commonly referred to as the Freedom of
Information Act) because of subsection (b) (4) of that Act. That sub-
section provides that the mandatory disclosure provisions of the Free-
dom of Information Act do not apply to matters that are "trade secrets
and commercial or financial information obtained from a person and
privileged or confidential." Thus any information which falls within
the term "trade secrets and commercial or financial information ob-
tained from a person and privileged or confidential" is generally pro-
tected from disclosure by section 14. Such information may, however,
be disclosed to officers and employees of the United States in connec-
tion with their official duties for protection of health or the environ-
ment or for specific law enforcement purposes. Such information may
also be disclosed to contractors with the United States and employees
of such contractors if in the opinion of the Administrator disclosure
is necessary for the satisfactory performance of the contract. Such
information may also be disclosed when relevant to any proceeding
under this Act, except that disclosure shall be made in a manner
designed to preserve confidentiality to the extent practicable without
impairing the proceeding.

The Committee adopted the language of subsection (b) (4) of the
Freedom of Information Act (5 U.S.C. 552(b)(4)) as the criterion
for information which merits confidential treatment for several
reasons. Since there is a bod;v of case law interpret in^r subsection
(b)(4), the confidentiality criterion will be more definite. Further,
since the Administrator must handle requests for information under
both this bill and the Freedom of Information Act, use of the same
standard will promote uniformity in the handling of such requests.
As a result, there should be greater certainty as to the rights of in-
dustry to have data withheld and the rights of the public to obtain
data.

Subsection (b) (1) of section 14 provides tl^at subsection (a) does not
prohibit the disclosure of any health and safety study submitted under
the bill or any data submitted from sucli a study with respect to (1)
any chemical substance or mixture which on the date the information
is to be disclosed has been offered for commercial distribution or (2)
any substance or mixture for which testing is required under section
4 or for which notification is required under section 5. However, if a
health and safety study contains (1) data which discloses processes
used in the manufacturing or processing of a chemical substance or
mixture or (2) data disclosing the portion of a mixture comprised by
any of the chemical substances in the mixtur^x^^nd if sUch data would

ll 79-313 O - 77 - 30

458

otherwise be entitled to protection from disclosure under subsection
(a), then such data is not to be disclosed. In referring to data "dis-
closing the portion of the mixture comprised by any of the chemical
substances in the mixture," the Committee intends to protect confiden-
tial trade secret information respecting the specific formulation of a
mixture. However, the Committee does not intend to prohibit the Ad-
ministrator from disclosing the chemical substances comprising the
mixture by their order of quantity in the mixture.

Subsection (b) (2) provides that if a requost is made under the Free-
dom of Information Act for health and safety information obtained
under this bill, the Administrator may not deny the request on the
basis of the exemption provided in subsections (b) (3) or (b) (4) of 5
U.S.C. 552. Thus, health and safety information which is not subject to
the prohibition on disclosure prevscribed by section 14(a) of the bill is
not exempt from disclosure under subsection (a) of section 552 by vir-
tue of subsection (b) (4) of that section. In addition, in considering a
request under the Freedom of Information Act, the Administrator may
not disregard section 14(b)'s specific exemption for health and safety
information from section 14 (a) 's prohibition on disclosure and assert
that section 14(a) provides a statutory exemption from disclosure of
such information.

The purpose of subsection (b) is to clarify that health and safety in-
formation is not entitled to confidential treatment either under sub-
section (a) or the Freedom of Information Act. The subsection should
not be construed to imply that in the absence of such a provision, health
and safety information would be entitled to such confidential
treatment.

Subsection (c) provides that any person submitting data under the
bill may designate that data which the person believes is entitled to
confidential treatment. Such data may be submitted separately from
the other data. If the Administrator proposes to release data which
has been so designated, the Administrator shall notify in writing and
by certified mail the person who submitted the data. If the release of
data is made pursuant to a request under the Freedom of Information
Act, the notice must be given immediately upon approval of the re-
quest by the Administrator. Sucli immediate notification is required
so that any disclosure required under the Freedom of Information
Act shall not be unduly delayed by the requirements of this subsection.
The Administrator may not release the designated data until the ex-
piration of 30 days after the person submitting the data has received
the notice.

Subsection (d) provides criminal penalties for officers and em-
ployees of the United States and former officers and employees who
knowingly and willfully disclose information protected from dis-
closure by section 14. Penalties of up to one year imprisonment or a
fine of uj) to $5,000 or both are provided. Since this subsection provides
for criminal penalties, section 1905 of title 18 of the United States
Code (respecting criminal penalties for disclosure of confidential
information) is waived.

Subsection (e) provides that all information reported to or other-
wise obtained by the Administrator under the bill shall be made avail-
able upon written request of any duly authorized committee of the

459

Congress to such committee. It is the Committee's view that the inher-
ent authority of Congress, as the constitutionally established legisla-
tive branch, assures access to such information, and thus the provision
is not necessary to assure such access. Rather, the provision was in-
chided merely to give expression to such power and sets forth pro-
cedures for the exercise of the power.

SECTION 15, PROHIBITED ACTS

Section 15 makes it unlawful for any person to fail or refuse to com-
ply with any section of the bill, or any rule, order or requirement
promulgated under the bill. Specifically, the section forbids any per-
son to fail or refuse to comply with any rule or order promulgated
under section 4, any requirement prescribed by section 5, or any rule
or order promulgated under section 5 or 6. It also forbids any person
to use for commercial purposes a chemical substance or mixture which
the person knew or had reason to know was manufactured, processed,
or distributed in commerce in violation of section 5, a rule or order
under section 5 or section 6, or an order issued in an action under
section 5 or 7. The term used for commercial purposes is intended to
be interpreted broadly to include any use in manufacturing, processing,
or distribution in commerce or any other activity for commercial pur-
poses. Further, the section forbids any person to fail or refuse to es-
tablish or maintain records, submit reports, notices or other informa-
tion or permit access to or copying of records as required by the bill
or any rule under the bill. In addition, this section forbids any person
to fail or refuse to permit entry or inspection as required by section 11.

SECTION 16, PENALTIES

Section 16 states the penalties for violations of section 15 of the
bill.

Subsection (a) provides that any person who violates a provision of
section 15 shall be liable for a civil penalty of up to $25,000 for each
such violation. Each day a violation continues shall constitute a sepa-
rate violation. A civil penalty is to be assessed by the Administrator
by an order made on the record after opportunity for a hearing in
accordance with the provision of section 554 of title 5 of the United
States Code. The opportunity for a hearing shall be provided by giving
written notice to any person who may be subject to the order.

The notice shall inform the person that the Administrator proposes
to issue an order assessing a civil penalty. The Administrator must
provide the person an opportunity to request, within fifteen days of
receipt of the notice, a hearing on the order. Although commission of
one of the acts prohibited by section 15 automatically makes one sub-
ject to the assessment of a civil penalty, the Administrator may take
into consideration certain mitip^atinsr circumstances in determining
the amount of the civil penalty. The Administrator shall consider the
nature, circumstances, extent, and irr'^vitv of the violation. The Ad-
ministrator shall also consider the ability of the violator to pay, the
effect on the violator's ability to continue to do business, any history
of prior violations, the degree of culpability, and other matters as
, justice may require. The Administrator is granted discretion to com-

460

promise, modify, or remit any civil penalty which may be imposed
under subsection (a). Although no time period is provided in the
statute, it is anticipated that any compromise, modification, or remis-
sion would occur within a reasonable time after assessment of the civil
penalty.

Any person who requested a hearing respecting the assessment of a
civil penalty and who is aggrieved by an order assessing such a pen-
alty may file a petition for judicial review of the order with the United
States Court of Appeals for the District of Columbia or for any other
circuit in which the person resides or transacts business. The petition
must be filed within thirty days after the date the order making the
assessn: -^nt is issued.

Actions for collection of civil penalties shall be brought by the At-
torney General.

Subsection (b) provides that any person who knowingly or willfully
violates any provision of section 15 shall be subject upon conviction to
a fine of not more than $25,000 for each day of violation or imprison-
ment ior not more than one year, or both.

Under subsection (c) the Administrator is authorized to require any
persoii who has manufactured, processed, or distributed in commerce a
chemical substance or mixture in violation of a requirement under par-
agraph (1) or (2) of section 6(a) to give notice of the risk associated
with the substance or mixture. Such person may be required to give
such notice to processors or distributors in commerce and, the extent
reasonably ascertainable, to any other person in possession of or ex-
posed to such substance or mixture. Such person may also be required
to give public notice of the risk and to either replace or repurchase the
substance or mixture. The determination that the person has manufac-
tured, processed, or distributed in commerce a chemical siibstance or
mixture in violation of a requirement under section 6(a)(1) or (2)
must be made by order made on the record after opportunity for an
agency hearing.

SECTION 17, SPECIFIC ENFORCEMENT AND SEIZURE

Section 17 provides for injunctive enforcement of requirements of
the bill. It also provides for seizure of any chemical substance or mix-
ture which was manufactured, processed, or distributed in commerce
in violation of the bill or any rule or order under the bill. Seizure is
also provided for any article containing such a substance or mixture.

Subsection (a) provides that the TTnited States district courts will
have jurisdiction to restrain any violation of section 15 (prohibited
acts) or to restrain any person from manufacturing or processing a
chemical substance before the expiration of any applicable period
under section 5. In addition, the district courts are granted jurisdic-
tion to restrain any person from taking any action prohibited by a
rule or order imder section 5 or 6 or to compel the taking of any action
required by or under the bill. This subsection also contains provisions
relating to venue, service of process and subpoena of witnesses.

Under subsection (b) any chemical substance or mixture which was
manufactured, processed or distributed in commerce in violation of
the bill or of any rule or order promulgated under the bill or any

461

article containing such substance or mixture shall be liable to be pro-
ceeded against for seizure and condemnation. Actions for such seizure
and condemnation may be brought in any United States district court
within the jurisdiction of which such substance, mixture, or article
is found, and the proceedings shall conform as nearly as possible to
proceedings in rem in admiralty.

SECTION 18, PREEMPTION

Section 18(a) provides generally that nothing in the bill shall effect
the authority of a State or political subdivision to establish or con-
tinue in effect regulation of any chemical substance, mixture or article
containing a chemical substance or mixture. However, except as other-
wise provided, rules under section 5 and 6 shall preempt nonidentical
State and local requirements respecting the same chemical substance,
mixture, or article containing a substance or mixture, if the State or
local requirement addresses the same risk to health or environment
associated with the chemical substance, mixture, or article. Similarly,
if the Administrator establishes a testing rule under section 4, no
State or political subdivision may establish or pontinuo in effect a test-
ing rule for purposes similar to those for which the testing is required
under section 4.

However, rules under section 6(a)(5) relating to disposal do not pre-
empt any State or local requirements. Further, if a State or local re-
quirement is adopted under the authority of the Clean Air Act or any
other Federal law, the Federal rule shall not preempt the State or local
requirement. Thus, for instance, Stat€ emission standards, effluent
limitations, or other regulatory requirements adopted under the Clean
Air Act or Federal Water Pollution Control Act would not be pre-
empted by rules issued under this bill, even though the State or local
requirement were more stringent. This would be the case if a State
limitation, standard, or requirement were adopted, submitted, and
approved as part of a State implementation plan required under Fed-
eral law. Similarly, the preemption would not apply to a State or
local limitation, standard, or requirement if it were adopted under
the State or local government's authority which is preserved by a
provision of Federal law, such as a scK^tion 116 of the Clean Air Act
or sections 1414(e) or 1424(c) of the Public Health Servic-e Act (re-
lating to safe drinking water) .

The Committee recognizes the traditional role of the State and local
governments in providing for the protection of their citizens. As a re-
sult in addition to the specific exemptions from the preemption pro-
vision, the Committee bill provides a means whereby a State or politi-
cal subdivision may seek an exemption from the Federal preemption
in order to provide a higher degree of protection for their citizens than
that provided by regulations under this bill. Under subsection (b) , the
Administrator mav by rule exempt from the preemption provisions a
requirement of a State or political subdivision if three conditions are
satisfied. First, compliance with the State or local requirement must
not cause a violation of the applicable requirement under the bill. Sec-
ond, the State or political subdivision requirement must provide a sig-
nificantly higher degree of protection from the risk. Third, the State

462

or local requirement must not through difficulties in marketing, dis-
tribution, or other factors, unduly burden interstate commerce.

SECTION 19, JUDICIAL REVIEW

Section 19 sets out the procedures for judicial review of rules issued
under sections 4, 5, or 6 of the bill. Subsection (a) provides that peti-
tions for judicial review must be filed within 60 days following the
promulgation of a rule under section 4, 5, or 6. Such petitions are to be
filed with the United States Court of Appeals for the District of
Columbia Circuit or for the circuit in which the petitioner resides or
in which the petitioner's principal place of business is located. The sub-
section contains provisions for filing the record of the proceedings on
which the rule was based. The Committee anticipates that ordinarily a
certified list of the record may be provided in accordance with appli-
cable appellate rules of procedure unless the court requests otherwise.

The record means any rule, any transcript required of any oral pres-
entation, any written submission of interested parties and any other
information which the Administrator considers to be relevant to the
rule and with respect to which the Administrator, on or before the date
of promulgation of the rule, published a notice in the Federal Register
identifying the information. Such notice need only list the informa-
tion ; it need not summarize such information.

By so defining the record, the Committee intends that the public be
fully apprised of the basis for the Administrator's action, l^he Admin-
istrator should include in the record those documents in the Adminis-
trator's possession which are of material relevance to the rule, includ-
ing, of course, those which contradict as well as support the Adminis-
trator's position. The Committee expects that the Administrator will,
throughout the proceedings for the issuance of a rule, keep current
and make available upon request a listing of information to be in-
cluded in the record, as well as permit access to and copying of docu-
ments to be included in the record.

Subsection (b) describes when the Court may require the Adminis-
trator to provide an opportunity for the petitioner to adduce addi-
tional data, views or arguments. The petitioner must show that such
data, views, or arguments are material and that there are reasonable
grounds for the petitioner's failure to adduce such data, views, or
arguments in the proceeding before the Administrator.

Subsection (c) grants the court jurisdiction to review the rule in
accordance with chapter 7 of title 5 of the United States Code and to
grant appropriate relief. Any rule promulgated by the Administrator
under section 4, 5, or 6 is to be affirmed unless the determination or
findings required to be made under the applicable section are not
supported by substantial evidence on the record taken as a whole.
Thus, it is the intent that the traditional presumption of validity of an
agency rule would remain in effect. The Committee recognizes that in
rulemaking proceedings which are essentially informal and which in-
volve both determinable facts and policy judgments derived there-
from, the traditional standard for review is that of "arbitrary and
capricious." The use of the substantial evidence standard for such
rulemaking is not, however, without precedent, and the courts have

463

adequately adapted to it.^ The Committee has chosen to adopt the
"substantial evidence test," for the Committee intends that the review-
ing court engage in a searching review of the Administrator's reasons
and explanations for the Administrator's conclusions. However, the
Committee does not intend to imply that the Court is to substitute its
judgment for the policy judgment of the Administrator.

The judgment of the court shall be final subject to review by the
Supreme Court. Further, such judgment may include an award of
costs of suit and reasonable fees for attorneys and expert witnesses
if the court determines that such is appropriate. Such costs o.f suit
and fees may also be awarded by the Supreme Court in its decision
on review of any such judgment.

Subsection (d) provides that the remedies provided in this section
shall be in addition to and not in lieu of any other remedies provided
by law.

SECTION 2 0, citizens' CIVIL ACTIONS

Section 20 authorizes actions by individuals to restrain violations
of the bill and to compel the Administrator to perform any statutory
duty arising under the bill. Such citizen actions can provide an im-
portant aid in enforcing the bill. In adopting the provision, your
Committee is following the ample precedent established in other
Federal laws. The Clean Air Act, Federal Water Pollution Control
Act, Noise Control Act, the Consumer Product Safety Act, and title
XIV of the Public Health Service Act (relating to safe drinking
water) all contain similar provisions. In addition a number of States
authorize citizen enforcement actions.

Subsection (a) authorizes any person to commence a civil action
to (1) restrain violations of the bill or any rule prescribed under
section 4 (testing), section 5 (manufacturing and processing notices)
and section 6 (regulation), or (2) compel the Administrator to per-
form any nondiscretionary act or duty under the bill. Actions shall
be brought in the district court in which the alleged violation occurred
or in which the defendant resides or has his or her principal place o.f
business. The district courts shall have jurisdiction without regard
to the amount in controversy or the citizenship of the parties. Citizen
suits against persons alleged to be in violation of the bill or a rule
issued under section 4, 5, or 6 may be brought against the United
States and against any other governmental instrumentality or agency,
but only to the extent permitted by the Eleventh Amendment to the
Constitution. The section does not authorize the collection of damages
in any such suit.

Under this provision, the person bringing the suit serves as a private
attorney-general to protect the public interest. Thus it is important
that the plaintiff be a competent and "appropriately" interested repre-
sentative of the public interest. The Committee believes that the wisest
means of assuring this is to rely upon the court's inherent power to
dismiss collusive suits and upon the broad rights of intervention in
suits under this section.

J^See Industrial Union Department, AFL-CIO v. Hodgson, 499 F.2d 467 (D.C. Clr.

464

To assist persons bringing suits under the section and similar sec-
tions of other laws administered by the Administrator, the Committee
recommends that the Administrator adopt uniform policies and proce-
dures: (1) governing the Administrator's role in such suits as inter-
venor or amicus ; (2) specifying the extent to which the Administrator
will comment on proposed consent orders; and (3) providing for co-
operation with parties instituting civil enforcement actions to insure
that the Administrator's expertise and factual data is made available
to such parties to the fullest extent possible.

Subsection (b) specifies certain limitations on the commencement of
a civil action under this section. Prior to the commencement of a civil
action to restrain a violation of the bill or a rule under the bill, the
plaintiflf must give 60 days notice to the Administrator and the alleged
violator. If the Administrator has instituted and is diligently prose-
cuting a civil action against the alleged violator to compel compliance,
no suit may be brought under the section. However, if the Adminis-
trator's action is not commenced until after the notification, the person
who gave notification may intervene in the Administrator's suit as a
matter of right.

Sixty days notification to the Administrator is also a prerequisite
to the commencement of an action against the Administrator to compel
the performance of a nondiscretionary act or duty, except in the case
of an action involving an imminent hazard. In the case of the alleged
imminent hazard, the notification period is 10 days.

Subsection (c) authorizes the Administrator to intervene as a mat-
ter of right in any civil action under this section to which the Admin-
istrator is not a party. The award of the costs of suit and reasonable
fees for attorneys and expert witnesses is authorized, if appropriate.

Nothing in this section shall restrict the right of any person under
any statute or the common law to seek enforcement of the bill, or any
rule under the bill, or to seek other relief.

Subsection (d) provides that, upon application of the defendant, a
court may consolidate two or more civil actions brought under subsec-
tion (a) involving the same defendant and the same issues or viola-
tions when such actions are pending in two or more judicial districts.

SECTION 21, citizens' PETITIONS

Section 21 provides an important mechanism for public initiation
of actions to protect the health and environment. Under section 21(a) j
any person may petition the Administrator to initiate a proceeding]
for the issuance, amendment or repeal of a rule under section 4, 5(c),
or6(a).

Subsection (b) sets out the procedures for such citizen petitions.
Any petition is to be filed in the principal office of the Administrator,
and it must set forth the facts which the petitioner claims establish
that it is neccssarv^ to issue, amend, or repeal a rule under section j
4, 5(c), or 6(a). A petition for amendment or repeal of an existing!
rule should contain newly discovered, noncumulative information
which was not presented for the Administrator's consideration in
promulgatinfif the rule or on any appeal of the rule, and failure to in-
clude such information would be adequate basis for denying the peti-

465

tion. Otherwise, the provisions of this section could vitiate the proce-
dures provided in section 19 for review of a rule under section 4, 5,
or 6.

The Administrator may hold public hearings or conduct any inves-
tigational proceeding appropriate to determine whether or not a peti-
tion should be granted. Within 90 days the Administrator must either
grant or deny the petition. If the petition is granted, the Administrator
shall promptly commence an appropriate proceeding to take the
action requested. If the petition is denied, the Administrator must
publish in the Federal Register the reasons for the denial.

If the Administrator denies the petition, or if the Administrator
fails to act on the petition within the specified 90-day period, the
petitioner may commence a civil action in a United States district
court to compel the initiation of the requested rulemaking proceeding.
Such action must be filed within 60 days.

Subsection (b)(4)(B) sets out provisions applicable to the civil
action in the case of a petition requesting the issuance of a rule under
5ection 4, o(c), or 6(a). Subsection (b) (4) (B) does not apply with
respect to civil actions respecting petitions for amendment or repeal
3f rules. Subsection (b) (4) (B) provides the petitioner for the issuance
of a rule with an opportunity for a de novo proceeding before the
30urt. If the petitioner makes certain requisite showings, the court
^hall order the Administrator to initiate the requested action unless
the court finds that the failure of the Administrator to initiate the
[•equested action was not unreasonable.

In the case of a petition for the issuance of a rule \mder section 4,
he petitioner must show that the manufacture, distribution in com-
nerce, processing, use or disposal of the substance or mixture to be
mbject to the rule may cause or significantly contribute to an un-
reasonable risk to health or the environment. If the petition was for
the issuance of a rule under section 5fc), the petitioner must
5how that the manufacture, processing, distribution in commerce,
ise or disposal of the substance requested to be subje-ct to the rule
•auses or significantly contributes to or may cause or significantlv
contribute to an unreasonable risk to health or the environment. If
he petition requests the issuance of a rule under section 6(a), the
Detitioner must show that there is a reasonable basis to conclude
hat the manufacture, processing, distribution in commerce, use or
iisposal of the substance or mixture causes or significantly contrib-
ites to or will cause or significantly contribute to an unreasonable
'isk to health or the environment.

If the petitioner makes the requisite sho\\'in2:, the court shall order
he Administrator to initiate the requested rulemaking action unless
he court finds that the failure of the Administrator to initiate such
iction was not unreasonable. In making the latter determination, the
^ourt is to consider the priorities of the Administrator, thp resources
ivailable to the Administrator to take the action requested by the peti-
ioner, and other relevant factors. The Committee intends that the
court carefullv review the Administrator's priorities and resources to
ietermine if the failure of the Administrator to initiate the requested
iction was unreasonable in light of the risk demonstrated by the peti-
ioner.

466

Although the court may order the Administrator to initiate the
requested rulemaking proceeding, the court may not determine Avhat
the final outcome of the rulemaking proceeding should be nor does
the court's determination that a proceeding should be commenced re-
lieve the Administrator of any responsibility to make any findings
which are requisite in the exercise of any of the authorities under
sections 4, 5 or 6. Costs of suits and reasonable fees for attorneys
and expert witnesses may be awarded if the court determines it is
appropriate. The remedies provided by section 21 shall be in addi-
tion to, not in lieu of, other remedies provided by law.

SECTION 22, NATIONAL DEFENSE WAIVER

Section 22 provides that the Administrator shall waive compliance
with any provision of the bill upon a request and a determination by
the President that the waiver is necessary in the interest of national
defense. If a waiver is provided the Administrator must maintain a
written record of the basis for the waiver and make the record avail-
able for in camera examination when relevant in a judicial proceed-
ing under the bill. The Administrator is to publish a Federal Register
notice informing the public that the waiver was granted for national
defense purposes unless upon request of the President, the Admin-
istrator determines to omit the publication because it would be con-
trary to the interests of national defense. In such a situation the
Administrator shall submit notice to the Armed Services Commit-
tees of the Senate and House of Kepresentatives.

SECTION 2 3, EMPLOYEE PROTECTION

Section 23 provides protection for employees who may cooperate
with the Administrator.

Subsection (a) prohibits any employer from discharging any em-
ployee or otherwise discriminating against any employee with respect
to compensation, terms, conditions, or privileges of employment be-
cause the employee (or persons acting under request of the employee)
has commenced, caused to be commenced, or is about to commence a
proceeding under the bill. Protection is also provided for any employee
who has testified, or is about to testify in any such proceeding, or has
assisted or participated in a proceeding or any other action to carry
out the purposes of the bill.

Under subsection (b) any employee who believes that he or she
has been discharged or otherwise discriminated against in violation of
the section may file a complaint with the Secretary of Labor. The
Secretary shall conduct an investigation of the alleged violation. The
investigation must be completed within thirty days of the receipt of
the complaint. Both the complainant and the person alleged to have
committed the violation shall be notified in writing of the results of
the investigation. Within ninety days of the receipt of the complaint,
the Secretary shall, unless there is a settlement respecting the com-
plaint, issue an order providing appropriate relief or denying the
complaint. Such order shall be made on the record after notice and
opportunity for agency hearing. If the Secretary determines that a

467

violation of this section has occurred, the Secretary shall order the
person who committed the violation to take affirmative action to abate
it, to reinstate the complainant alon^ with compensation including
back pay, terms, conditions, and privileges of the complainant's em-
ployment ; compensatory damages ; and where appropriate, exemplary
damages. Costs and expenses reasonably incurred by the complainant
in bringing the complaint may also be assessed.

Subsection (c) provides for judicial review of an order of the Secre-
tary. Any adversely affected person may obtain review of the Secre-
tary's order in the United States Court of Appeals for the circuit in
which the violation allegedly occurred. The petition for review must
be filed within 60 days from the issuance of the Secretary's order and
review shall conform to chapter 7 of title 5 of the United States Code.

Subsection (d) provides for enforcement of orders by the Secretary
in the district court for the district in which the violation occurred.
The district courts are granted jurisdiction to grant all appropriate
relief. Such actions shall be heard and decided expeditiously.

Subsection (e) provides that the section shall not apply to any
employee who deliberately caused a violation of any requirement of
the bill, unless the employee was acting under directions from the
employer.

SECTION 24, EMPLOYMENT EFFECTS

Section 24 (a) provides for continuing evaluations of the potential
effects on employment of any rule or order under section 4, 5 or 6 or
a requirement of section 5.

Subsection (b) authorizes the Administrator upon request of an
employee to investigate any discharge or layoff or threatened discharge
or layoff or other adverse effects on employment allegedly resulting
from a rule or order under section 4, 5 or 6 or a requirement of sec-
tion 5. The Administrator shall if requested by any interested person
hold public hearings on any matter involved in the investigation un-
less the Administrator determines that there are no reasonable grounds
for holding such hearings. The person requesting the hearing must
be notified in writing of any determination not to hold a requested
hearing.

If public hearings are held, the Administrator must provide at least
five days notice to the person making the request for the investigation
and to any person identified in such requests. A transcript shall be
made of the hearings and each employee who requested a hearing
and the employer of such employees shall be required to present in-
formation respectin.q the adverse effects or threatened adverse effects.
Upon completion of the investigation, the Administrator shall make
findings of fact and any recommendations deemed appropriate. Such
findings and recommendations shall be made available to the public.

Subsection (b) also provides for subpoenas, oaths and payment of
witness fees.

SECTION 2 5, STUDIES

Subsection (a) requires the Administrator to conduct a study of
all Federal laws administered by the Administrator to determine
whether and under what conditions, if any. indemnification should be
accorded any person as a result of action taken by the Administrator

468

under such laws. The Greneral Accounting Office is to review and com-
ment on the adequacy of the study.

Subsection (b) requires the Council on Environmental Quality to
coordinate a study of the feasibility of establishincr a standard clas-
sification system of chemical substances and related substances and a
standard means for storing and obtaining rapid access to information
respecting such substances.

SECTION 2 6, ADMINISTRATIOX OF THE ACT

Section 26(a) provides that upon request by the Administrator,
each Federal department and agency is authorized to make its serv-
ices, personnel, and facilities available to the Administrator to assist
in the administration of the bill and to furnish to the Administrator
such information, data, estimates, and statistics and to allow the Ad-
ministrator access to all information in its possession as the Ad-
ministrator may reasonably determine to be necessary for the admini-
stration of the bill.

Subsection (b) provides that the Administrator may by rule require
the payment of reasonable fees from any person required to submit
data under section 4 or 5 to defray the cost of administration of the
bill. The fee may not exceed $2,500. In setting the fee the Administra-
tor must take into account the ability to pay of the person required to
submit the data and the cost of the Administrator of reviewing the
data. Such fees may be shared in cases where the expenses of testing
are also shared.

Subsection (c) authorizes the Administrator to take action with
respect to categories of chemical substances or mixtures rather than
with respect to individual chemical substances or mixtures. For ex-
ample, if under section 4(a) the Administrator finds that the manu-
facture, distribution in commerce, processing, use. or disposal of a
category of chemical substances may cause or significantly contribute
to an unreasonable risk, that there are insufficient data and experience
with respect to that category, and that testing of that category of sub-
stances is necessary to develop data, the Administrator could issue a
section 4(a) testing rule respecting the category of chemical sub-
stances. Of course, once test data has been submitted by a manufac- ;
turer or processor with respect to a substance within the category, |
such data may provide a basis for manufacturers and processors of '
other chemical substances within the category to apply as provided in
section 4(c) for an exemption from the testing requirement and
thereby unnecessary time and expense could be saved the affected man- !
ufacturers and processors by not having to test each minor modifica- j
tion of substances within the category. j

It should be noted that in taking action under any provision of the I
bill respecting a category of chemical substances, the Administrator
will not have to make the requisite finding for such action with respect |i
to every chemical within the category. j

The Committee agrees with the National Academy of Science rec- jj
ommendation that the EPA adopt, whenever scientifically possible, a j
generic approach for the regulation of chemicals.^

* "Decisionmaking for Regulating Chemicals in the Environment", p. 43 (1975).

469

The subsection defines the terms category of chemical substances
and category of mixtures. *

Subsection (d) directs the establishment within the Environmental
Protection Agency of an identifiable office to carry out the following:

(1) The provision of technical and other nonfinancial assist-
ance to manufacturers and processors respecting the requirements
of the bill which they must meet.

(2) Informing manufacturers and processors of the policy of
the agency respecting the application to them of the requirements
of the bill.

(3) Informing manufacturers and processors of the means and
methods by which they may comply with such requirements.

The office to be created should provide an important means of insur-
ing that manufacturers and processors are fully informed of the
provisions of the bill. The services of the office should be particularly
helpful to small and medium-sized manufacturers and processors
which typically do not have an extensive legal staff to deal wuth the
complexities of the bill and rules promulgated under it, and the
Committee intends that the assistance office focus its efforts on helping
such small and medium-sized manufacturers and processors. The
office should answer general inquiries concerning procedural and sub-
stantive requirements of the bill and rules promulgated under it as
well as respond to requests respecting the policy of the agency respect-
ing the application of requirements to a specific manufacturer or
processor. In addition, the Committee anticipates that the office will
provide assistance to manufacturers and processors by referring them
to other offices within the agency when it is necessary for inquiries to
be handled by another office. Of course, the provisions of section 14
respecting disclosure of data would apply to any information re-
ceived by the assistance office from a manufacturer or processor.

In addition to responding to inquiries, the office should through
publication of pamphlets, circulars, and other methods conduct gen-
eral educational efforts designed to reach manufacturers and proc-
essors and inform them of the requirements of the legislation,
j Certain regulatory statutes contain provisions granting general
rulemaking authority to the agencies administering the statutes. See,
e.g., section 701 of the Federal Food, Drug, and Cosmetic Act. How-
ever, such provisions have been construed to grant such agencies sub-
stantive rulemaking authorit}'. The bill contains specific grants of sub-
stantive rulemaking authority to the Administrator (see, e.g., sections
4, 5, 6, and 8) and the Committee does not intend that the Adminis-
trator have any substantive rulemaking authority which is not spe-
cifically granted. A general rulemaking authority is not needed to
authorize the issue of procedural, interpretative, or similar adminis-
trative rules,^ consequently, such a provision is not included in the bill.

SECTION 2 7 , DEVErX)PMENT AND EVALUATION OF TEST METHODS

This section provides authority for the conduct of and financial
assistance for projects for the development and evaluation of inexpen-
sive and efficient methods for determining and evaluating the health

1 See authorities cited In Morrow v. CUiifton, 326 F.2d 36. 44 (1963).

470

and environmental effects of chemical substances and mixtures, which
methods may be used in developing test data to comply with a section 4
testing rule. The Secretary of Health, Education, and Welfare will,
in consultation with the Administrator and acting through the office
of the Assistant Secretary for Health, administer this section.

The Secretary is to make annual reports to Congress respecting
grants and contracts made under this section and is to periodically
publish in the Federal Register reports describing the progress and
results of projects assisted by such grants and contracts.

In adopting this section the Committee has indicated its intent
that efforts should be made to develop and evaluate inexpensive and
efficient testing methods. Such methods could significantly reduce the
cost and time involved in complying with testing rules under section 4.

SECTION 2 8, AUTHORIZATION OF APPROPRIATIONS

Section 28 authorizes to be appropriated to the Administrator for i
carrying out the hill $11,100,000 for the 1978 fiscal year, $10,100,000
for the 1979 fiscal year, and $11,100,000 for the 1980 fiscal year. No
part of the funds so authorized to be appropriated shall be used to
construct any research laboratories.

SECTION 2 9, ANNUAL REPORT

Section 29 requires the Administrator to prepare and submit to the
President and the Congress annually a comprehensive report on the
administration of the bill. The report shall include information
regarding testing required under section 4; notices under section 5;
action taken under section 5(g) ; rules issued under section 6; judicial
actions taken under the bill; and a summary of major problems
encountered in the administration of the bill and recommendations
for additional legislation.

SECTION 30, EFFECTIVE DATE

Section 30 provides that the effective date of the bill shall be
October 1, 1977.

PROGR.VM Oversight

The bill provides new authority for the Administrator of the En-
vironmental Protection Agency. Consequently, no oversight activities
have been conducted by the committee with respect to such authorities
and no oversight reports have been made by the Committee's Subcom-
mittee on Investigations and Oversight or the Committee on Govern-
ment Operations.

Inflationary Impact Statement

Pursuant to rule XI, clause 2(1) (4) of the Rules of the House of
Representatives, the Committee makes the following statement regard-
ing the inflationary impact of the reported bill :

Information available to the Committee indicates that the infla-
tionary impact of the bill would be extremely slight. The Environ-

471

mental Protection Agency has estimated that the annual cost of the
legislation to the regulated industry will range between $80 to $140
million. The General Accounting Office reviewed the EPA estimate
and concluded that it was probably realistic, although testing costs
could be somewhat higher than estimated by EPA, resulting in total
annual costs to industry of $100 to $200 million.

Taking into account such annual costs to industry of $100 to $200
million and projected EPA expenditures of $11 million annually, the
inflationary impact of the legislation should be extremely small. These
annual costs are equivalent to about one percent of the annual cost of
$20 billion wliich will be expended for water and air pollution controls
during the 1973-1982 period, as estimated by the Council of Environ-
mental Quality. A study performed by Chase Econometrics, Inc.,
Macroeconamic Aspects of Federal Control Programs, concludes that
an annual expenditure of $20 billion during the 1973-1982 period
would result in an average annual rate of increase of 0.2 percent for
the Wholesale Price Index. 0.1 percent for the GXP Price Index, and
0.2 percent for the Consumer Price Index. Since the estimated ex-
penditure for this bill is only a fraction of that utilized in the Chase
Econometrics, Inc. study, the inflationary impact would be substan-
tially lower than that projected in that study. As a result, the Com-
mittee concludes that the inflationary impact of costs of the bill will
be extremely slight.

COXGRESSIOXAL BlTXSET OfFICE CoST ESTIMATE

July 1, 1976.

1. Bill Number: H.R. 14032.
i 2. Bill Title : Toxic Substances Control Act.

3. Purpose of Bill :

This bill establishes procedures and authorizes the appropria-
tion of funds to regulate potentially toxic chemical substances. It
mandates the Administrator of the Environmental Protection
Agency (EPA) to develop regulations to ensure adequate
testing of potentially toxic chemicals. It requires that the Ad-
' ministrator be notified of the impending introduction of any new
chemical or significant new uses of existing ones, and empowers
him to delay such introduction up to ninety days. The bill also
authorizes the Administrator to issue rules which prohibit or
limit the manufacturing, processing, or distribution of dangerous
chemicals or mixtures, and to carry out inspections. Various guide-
lines and procedures are established for the Administrator to fol-
low in implementing the bill, as well as for citizens' civil actions
and petitions to the Administrator.

The bill authorizes appropriations of $11.1 million for fiscal
year 1978, $10.1 million for fiscal year 1979, and $11.11 million for
fiscal year 1980 for the purpose of carrying out this Act. This is
an authorization bill, which requires subsequent appropriation
action.

4. Cost Estimate : This bill would authorize appropriations for the
toxic substances control projrram for fiscal years 1978 through 1980.
The budget impact of this bill is shown belowl

472

[In millions of dollars]

Fiscal year-

1978

1979

1980

1981

1982

1983

Authorization level

11.10

10.10

11.11

Estimated cost..

8. 30

9. 50

10. 80

2.70

0. 90

0.11

All costs in this bill fall within Function 300.

5. Basis of Estimate : Tlie Office of Toxic Substances in EPA, which
will implement this bill, estimates that general abatement and con-
trol activities (e.g., promulgating testing guidelines and monitoring
new chemical introductions) will require seventy-five percent of the
authorized amounts. Research projects are estimated to require twenty
percent of the funds, and enforcement efforts, five percent. EPA antic-
ipates the following spending rates for these types of accounts.

PERCENTAGE OUTLAY DISTRIBUTION

Year 1

Year 2

Year 3

Year 4

Abatement and control

Research

Enforcement . _ .

6. Estimate Comparison : None.

7. Previous CBO Estimate : None.

8. Estimate Prepared By: Leo J. Corbett (225-5275)

9. Estimate Approved By :

James L. Blum,
Assistant Director for Budget Analysis.

Agency Reports . ;

Enviroxmextal Protection Agexcy,

Washington, D.C., June 27, 1975.

Hon. Harley O. Staggers,

Chairm-an, Comm ittee on Interstate and Foreign Commerce, Home of
Representatives, Washington, D.C.

Dear Mr. Chairman : This is in response to your requests of June 3.
1975 and June 17, 1975, for the views of the Environmental Protection
Agency on H.R. 7229 and H.R. 7664. similar versions of the "Toxic
Substances Control Act,'' pending before your Committee.

This Agency and otlier concerned Federal departments and agenciefi
liave just recently completed the development of the Administration'?
position on S. 776, a similar version of the Toxic Substances Control;
Act that is pending befoi-e the Senate Commerce Committee. Because
many of the provisions in the House bills are identical or similar tc
provisions in the Senate bill, and in order to expedite our commentsi
to you with legard to this legislation, we are submitting our detailedi
comments on the Senate bill to you. These comments on the similat :
Senate legislation and our testimony now scheduled to be presented!

473

before your Subcommittee on Consumer Protection and Finance on
July 10. 1975. will constitute our report to you on the toxic substances
control lejrislation.

Subject to adoption of the Administration's recommendations on
this le^rislation as set out in our attached repoil on S. 776, and as will
be included in our testimony before the Subcommittee, we would urge
enactment of the Toxic Substances Control Act.

Mv staff and I stand ready to assist your Committee in any way
possible toward the enactment of satisfactory legislation to control
ha7ardous substau'^es.

AVe are advised by the Office of Management and Budget that there
is no ob^"ection to tbp submission of this report from the standpoint of
the proirram of the President.
Sincerely yours,

John R. Quarles, Jr.,
A cting A d imnistrato r.

Enclosure.

Environmfa'tat, Protection Agency,

Washington, June 2S, 1975.

Hon. AVarrfn G. Magnuson,
Chainnan^ Comm ittee on Commerce,
U.S. Senate, Washington, B.C.

Dear Mr. Chairman : This is in response to your request of March 6,
1975, for the views of the Environmental Protection Agency on S. 776,
the "Toxic Substances Control Act."

We are in accord with the obiectives of S. 776 and the general
approach taken in the bill to control toxic substances. As we testified
before your Subcommittee on the Environment on March 10, 1975,
the bill contains the authorities which we believe are essential for
effective toxic substances control legislation. We urged the enactment
of toxic substances control legislation and indicated that we would
have suggestions on some of the specific provisions of S. 776 when we
submitted our report.

We note that S. 776 contains significant improvements over some
of the toxic substances control bills that have been l)efore the Commit-
tee the past four years. Many of these improvements are consistent
with past EPA recommendations. It is not our intention in our report
by concentrating on suggested revisions to the bill to detract from or
fail to recognize the effort and improvements already evident in S. 776.

We have already stated in our testimony our objection to the pro-
vision that would preclude the Administrator from forwarding any
budget estimates, legislative proposals, comments on legislation, or
testimony to the Office of Management and Budget prior to the trans-
mission of these same materials to the Congress. We also stated in our
testimony that to designate by statute the specific responsibility of an
Assistant Administrator may tend to create a problem of internal
management.

We will discuss below a number of additional areas in S. 776 where
we have particular problems and where we believe amendments are
in order. Theses proposed amendments are set out in an attachment
to this letter along with a number of important additional amend-
ments and brief explanations of each. We urge that all of these amend-
ments be favorably considered by the Committee.

79-313 O - 77 - 31

474

POLICY OF ADMINISTRATION

AVe are proposing that the "Declaration of Policy" section of the bill
include recognition of the role of this legislation in complementing
and supplementing a number of present Federal programs that deal
with various aspects of toxic substance control. We are also proposing
that the general requirement of the bill for consultation and coordi-
nation make specific reference to this policy statement. Such amend-
ments would be of great assistance in the day to day administration
of this legislation, both by assuring due regard for the responsibilities
of other agencies, and by helping to establish the atmosphere of co-
operation and interchange which is vital to the successful operation
of comprehensive toxic substances legislation.

In line with this policy, and because of the special role of the Occu-
pational Safety and Health Act of 1970 in providing workers with
protection from unsafe or unhealthful working conditions which may
be created through the manufacture, distribution or use of toxic sub-
stances, we are also proposing some language for the bill and some
language for the Committee report to assure that there will be no
question about the respective regulatory jurisdictions of EPA and the
Department of Labor.

DEFINITIONS

We are proposing that the definition of "chemical substance" be
amended to provide the Administrator with some flexibility to ex-
clude, in appropriate situations, certain substances from the defini-
tions and thus from the requirements of the Act or from particular
provisions of the Act. It would be almost impossible to draft the bills
to exempt certain substances from the Act or, as more likely the case,
from certain provisions of the Act in each situation where such is
necessary. Scientific laboratory reagents are an example. Here it may
very well be appropriate to exclude such products from the testing
and regulatory provisions, but not necessarily the reporting and ad-
verse effects provisions when they are used by certain research or sci-
entific laboratories; on the other hand, we would not likely wish to
exclude high school laboratories from any labeling requirements. An
exclusion may also be in order for a substance not manufactured in
commercial quantities. An excessive burden and inconvenience to the
industry or the user would be averted Avith this flexibility in the Act.

We anticipate that the Administrator would exercise his discretion
to exclude from the definition of chemical substances most substances
manufactured in less than commercial quantities for the purpose of
testing. Thus, most substances manufactured in less than commercial
quantities would be exempt from the testing provisions of the bill.
The proposed amendment Avould however enable EPA to require test-
ing in those cases where the potential threat to health and the envir-
onment showed such testing to be necessary.

We are also proposing to add to the Act a definition for a "new
chemical substance." This is necessary in order that chemical sub-
stances which were used in previous years for some purpose, and such

475

6iS

use discontinued, do not become classified as existing chemicals, and
thus exempt from certain requirements relating to new substances.

TESTING

The testing provisions provide that standards for test protocols
would be promulgated, rather than the test protocol itself. Testing
would be required only for substances which the Administrator deter-
mines may present an unreasonable risk to health or the environment,
where there are insufficient data to conclude that such a risk does or
does not exist, and where testing would assist in making such a
determination.

There is a provision in the testing requirement of the bill that we
foresee as an undue burden upon the Administrator. While we agree
that provision should be made for the sharing of testing costs in the
event that there is more than one manufacturer of a substance for
w^hich testing is required, we are vei'y reluctant to become involved
in designating which manufacturer (or possibly a third party) should
conduct the tests if the parties cannot reach an agreement. We are
therefore recommending deletion of the provisions authorizing the
Administrator to designate which party should do the testing.

A further amendment we are proposing with regard to the testing
provisions is a specific requirement that the Administrator nmst con-
sider alternative methods for meeting the standards for test protocols
proposed by a manufacturer, such as one that might be less costly or
more effective. This would insure that industry is allowed to use the
best test protocols in meeting the testing standards.

PREMARKET SCREENING

We are proposing an amendment which will delete the authority in
i the bill to treat a rule proposed under section 6 during the premarket
review period of a product as a final rule. Thus a chemical substance
or product may be manufactured and distributed after the premarket
review period unless a restriction is obtained under the imminent
hazard provision of the Act. The substance or product, however, re-
mains subject to all other provisions of the Act and a rule prop<)sing
restrictions on the substance or product may be proposed immediately
during the premarket review period under section 6 and the rulemaking
i proceedings initiated at that time.

If it appears that the manufacture, processing, or distribution of a
chemical substance or product will result in any unreasonable threat
to human health or the environment prior to the completion of the
rulemaking proceedings, action may be taken to restrict or ban it
under the imminent hazard provisions of the bill, thus preventing it
from becoming a threat to health or the environment.

QUOTAS

Another difficulty we have with S. 776 concerns the requirement that
I the Administrator provide for the assignment of quotas in any regu-
1 lation limiting the amount of a substance which may be manufactured,
n imported, or distributed. The manda-tory requirement of a quota sys-

476

tern would make the regulatory process vastly more cumbersome and
difficult to administer. Thus, we recommend that the quota provision
be deleted. The Act already provides that when it is necessary to
adopt a rule with respect to a chemical substance to protect against an
unreasonable risk, the Administrator shall select the least stringent
requirement practicable consistent with protection of health and the
environment. In our view, restrictions limiting the amount of a sub-
stance that may be manufactured Avould be the most stringent require-
ment, other than a total ban, and the establishment of quotas would
seldom be necessary. Nevertheless, we strongly recommend against be-
coming involved in the establishment of quotas for various manufac-
turers, even in such limited situations.

ECONOMIC IMPACT

S. 776 would require that the Administrator consider a number of
relevant factors in promulgating rules with respect to a chemical
substance. We are proposing that a specific provision be added that
he also must consider the economic impact of such action, including,
but not limited to, consideration of the effects on business, employ-
ment, and the national economy. Consideration of these factors are
already inherent in the requirement that he consider all relevant fac-
tors. This amendment is submitted in lieu of other proposals that have
already been made for the mandatory preparation of detailed eco-
nomic impact statements at the time a regulation is promulgated.

HEALTH AND SAFETY STUDIES

We are proposing a revision of the requirement for the submission
of health and safety studies, or lists of such studies, in order to pro-
vide some flexibility in this requirement. This should lessen the burden
to industry in compiling the lists or submitting the studies, and to
EPA in not being overburdened with information it does not need or
cannot effectively use. The amendment would require submission of
lists of on-going and new studies, rather than the study, with a right
to require the submission of a given study. It would authorize the
Administrator to provide by regulation the types of studies to be
included on the lists and the number of years for which prior studies
must be listed. The amendment would also provide that a person
would list studies which he knows are being made or have been made.

CONFIDENTIAL INFORMATION

We are recommending that the confidentiality provision, section
15 of S. 776, be amended in several respects. First, the substantive
criterion for withholding data as confidential should be the test es-
tablished bv the Freedom of Information Act, 5 U.S.C. 552(b)(4).
Our proposed amendment would have the effect of requiring nondis-
closure of information obtained under the Toxic Substances Control
Act which may be withheld under 5 U.S.C. 552(b) (4), i.e., "trade
secrets and commercial or financial information obtained from a per-
son and pi-ivileged or confidential." This will make the confidentiality
standard more definite (because there exists a body of case law inter-
preting 5 U.S.C. 552(b) (4) ) , and will promote uniformity.

477

In addition to the exemption for disclosure to Federal officers and
employees, a separate provision should allow disclosure to EPA con-
tractors and their employees, under appropriate safeguards and after
appropriate EPA findings that disclosure is necessary. EPA accom-
plishes a great deal of its Investigatory and analytical tasks by con-
tract. If contractors are not allowed access to information under this
bill. EPA could not perform its duties satisfactorily without substan-
tial manpower increases. The recently-enacted Privacy Act, 5 U.S.C.
552a. provides that, for purposes of the section of the Privacy Act
which imposes penalties on Government employees for wrongful use
or disclosure of information entitled to confidentiality. Government
contractors and their employees are to be considered Government em-
ployees (5 U.S.C. 552a (m) ). AVe recommend inclusion of such a pro-
vision in the toxic substances bill. Our proposed amendments allow
disclosure to contractors, and include a penalty for wrongful disclos-
ure of information by Government employees (including contractors
and their employees).

AVe also believe that the provisions relating to qualified scientists
and individual names are not necessary. The term ''qualified scien-
tists'' would be difficult to interpret, and in any event a scientist
would have no greater rights under the subsection than would any
person under our (proposed) basic confidentiality criterion. We be-
lieve that the Federal Privacy Act and the Freedom of Information
Act provide ample i)rotection of the rights of individuals whose names
appear in health and safety records.

Finally, w^th regard to access of information by Congress, we be-
lieve that such confidential information should be made available upon
written request.

EXEMPnOX FROM FEDERAL PREEMPTION

We do not recommend the provisions of S. 776 which would allow
State and local agencies to petition the Administrator for exemption
from the I^ederal preemption requirements. State and local agencies
would be allowed to regulate any toxic substance until such time as
the Administrator puts into effect regulations for testing or restricting
a substance. Thereafter, they could impose only a total ban on a
substance. In view of the fact that the bill authorizes the Adminis-
trator to regulate with respect to geographic areas there would appear
to be no need for a State or local agency to duplicate any regulations
with respect to a substance after Federal regulations are in effect.

INTERAGENCY COOPERATION AND COORDINATION

Several amendments are being proposed to the Act to provide for
the maximum cooperation and coordination among the several agen-
cies of the Federal Government which have programs and responsi-
bilities concerned with toxic substances. These amendments also would
clarify that the Act is intended to complement and supplement exist-
ing laws and regulations such as the occupational health and safety
requirements.

A number of Federal agencies, particularly the Department of
Health, Education, and Welfare and the Occupational Health and
Safety Administration of the Department of Labor have extensive

478

responsibilities relating to toxic substances and human health and
would stand to benefit from various provisions of the Act. For ex-
ample, test results and other data generated in this area would, of
course, be valuable to them and should be made available to all agen-
cies concerned.

We are also recommending that the provision contained in previous
bills before the Congress directing the Council on Environmental
Quality to coordinate a study on the feasibility of establishing a stand-
ard classification system for chemical compounds and means of obtain-
ing rapid access to information on such substances be restored to the
Act. This section provides CP^Q the lead in establishing information
systems in a manner currently being initiated. This is being done in
conjunction with the agencies that would have been represented on the
interagency committee as set out in the provision proposed to be
deleted.

APPROPRIATIONS

We wish to make clear that our budget requests over the past several
years have included funds to handle work anticipated to be required
under toxic substances legislation, in the expectation that it would by
now have been a reality. Consequently, considerable ground work has
been laid and we anticipate that activities during fiscal year 1976 can
be met within the $8 million requested in the President's budget.
Furthermore, we would point out that EPA wishes to remain in accord
with the President's stated policy of holding new spending to an ab-
solute minimum. Consequently we would point out that the authoriza-
tion levels in S. 776 are in excess of amounts required to implement its
provisions.

We have outlined above in our letter a number of the proposed
amendments to the Act which we consider important; the attachment
contains both these and additional amendments which we believe are
of equal importance. We strongly believe that the adoption of these
amendments would iiviprove and strengthen the legislation and enable
EPA to protect the health and the environment to the greatest prac-
tical extent while at the same time relieving the industry as well as
the Government of some burdensome requirements.

With the favorable consideration of these proposed amendments,
we would urge the ejiactment of S. 776.

My staff and I stand ready to assist your Committee in any way
possible.

We are advised by the Office of Management and Budget that there
is no objection to the submission of this report from the standpoint of
the program of the President.
Sincerely yours,

John R. Quarles, Jr.,
Acting Administrator.

Toxic Substances Control Act

PROPOSED AMENDMENTS BY EPA AND OTHER FEDERAL AGENCIES TO S. 7 7G

7. Definitions

a. Page 4, lines 1 and 2, delete the language "or in some other way
suitable for formation of a group for the purposes of this Act".

479

Explanation. — This amendment would delete the open-ended au-
thority to designate almost- any grouping as a "category of chemical
substances".

b. Page 4, line 5, delete paragraph (3) and insert new paragraph
(3).

"(3) 'Chemical substance' means any chemical substance which
(A) has an organic or inorganic particular molecular identify; (B)
is any combined or uncombined radical or element; or (C) is any
mixture; Provided, however, the Administrator may by regulation
exclude from this definition as it applies to this Act, or to any provision
of this Act, certain categories of chemical substances such as scientific
laboratory reagents and samples, or chemical substances not manufac-
tured in commercial quantities."

Explaiiotiori. — This amended definition of a "chemical substance"
would provide the Administrator with flexibility to exclude, in ap-
propriate cases, substances from the requirements of the Act, or a
particular provision, where it does not need to be regulated, cannot
be effectively regulated, or where meeting the requirements might be
an undue burden. Scientific laboratory reagents, samples, and other
chemical substances manufactured in less than commercial quantities
are examples.

We urge the following language be included in the committee re-
port with respect to this definition :

"Chemical substance would be defined to permit the Administrator
The flexibility to provide by regulation for exempting chemical sub-
stances in certain categories or in less than commercial quantities from
certain provisions of the bill. With respect to those chemical sub-
stances, it is anticipated that the Administrator will exercise his dis-
cretion to exclude, and thereby exempt, most of them from the testing
provisions of the bill. The Administrator retains the authority to re-
quire testing in those cases where he finds a potential threat to health
and the environment wliich indicates that such testing is necessary."

c. Page 5, line 2, delete the period and insert a semicolon after
"studies" and delete remainder of paragraph; and on line 12, delete
"study" and inspj-f stuHv, including health and safety data developed
pursuant to such study,".

Explanation. — Correspondence relating to alleged adverse effects
on health and similar reports are already required to be maintained in
the section SCd) regarding records, and an amendment is proposed
to authorize the Administrator to require submission of such records.
There is no need to include unconfirmed complaints and notices in the
definition of health and safety data and confusion results when this
is attempted. It is also proposed to specifically provide that a health
and safety "study" includes health and safety data developed pursuant
to such a study.

d. Page 6, iT-'sert after line 14 the following and renumber other
paragraphs accordingly.

"(15) 'new chemical substance' means any chemical substance which
has not been manufactured or imported in commercial quantities into
tlie Ignited States during the 18-month period immediatelv prior to
the effective date of this Act, regardless of its commercial production
or importation in the United States prior to such time."

480

Explanation. — A definition of "new chemical substance" is necessary
in order that chemical substances that were used in prior years and
were discontinued do not become classified as existing chemicals for
purposes of the Act.

2. Testing

a. Page 9, after Une 8, insert new paragraph (4) as follows :

"(4) The Administrator will consider alternative methods for meet-
ing the standards for test protocols proposed by any person or gov-
ernmental entity which is a manufacturer, processor, or importer of
such chemical substance."

Explanation. — This amendment would specifically direct the Ad-
ministrator to consider alternative methods for meeting the standards
for test protocols proposed by a manufacturer, such as less costly or
more effective test protocols.

Explanation. — We do not believe that the Administrator should be-
come involved in designating which party (or a third party) should
perform tests if tl e parties cannot agree among themselves. If a cost-
sharing arrangement is made for one of the parties to do the testing,
however, provision should be made to exempt the other parties from
the testing requirements.

c. Page 11, line 15, insert after "argi:ments," the following: "and
permit cross-examination to such extent and in such manner as in his
discretion he determines is necessary and appropriate in view of the
nature of the issue involved, the number of the participants and the
nature of the interests of sucli participants,''.

Explanation. — This amendment would permit limited cross-exami-
nation as is provided in the section 6 rulemaking procedures to restrict
toxic chemicals.

3. PremarJcet screening; imminent hazard

a. Page 12, line 3, after "substance" add the following sentence:
"Subsequent submission or request for submission of additional in-
formation shall not be regarded as changing the date of such notice."

Page 13, line 4, delete entire subsection (c) ; on line 25, delete begin-
ning with "Unless" through "90 days" on line 2, page 14, and insert
in lieu thereof "Ninety days"; renumber following subsections ac-
cordingly.

Page 14, line 10. after "substance" insert "before or,"
Page 22, line 13, after "environment," insert "that should be cor-
rected immediately, and".

Explanation. — These amendments will delete the authority in the
bill to treat a I'ule proposed under section 6 during the pT-emarket re-
view ]>oriod of a product as a final rule. Thus a chemical substance
or product may be manufactured and distributed after tlie premai-ket
review period unless a restriction is obtained under the imminent
hazard provision of the Act. The substance or pi-oduct, however, re-
mains subject to all other provisions of the Act and a rule proi)Osing

481

restrictions on the substance or product may be proposed immediately
during the premarket review period under section 6 and the rule-
making proceedings initiated at that time.

If it appears that the manufacture, processing, or distribution of a
chemical substance or product will result in any unreasonable threat
to human health or the environment prior to the completion of the
rule-making proceedings, action may be taken to restrict or ban it
under the imminent hazard provisions of the bill, thus preventing it
from becoming a threat to health or the environment.

The other amendments would clarify the date premarket notice
commences, that restrictive rules under section 6 may be promulgated
before or after manufacture or distribution of a substance, and that
an imminent hazard is a risk that should be corrected immediately.

4. Restrictions on hazardous chemical substances

a. Page 17, line 23, delete '^condition" and insert in lieu thereof
"circumstances", and insert the following language in the committee
report with respect to section 6 of the bill :

''The provisions of section 6 of S. 776 provide EPA with regu-
latory authority which will complement and supplement existing au-
thority to control hazardous substances but not to preempt autliority
already vested by statute in other Federal depai-tments or agencies.
Proposed new section 9(b) would preclude EPA from taking action
under sections 6 and 7 which the Secretary of Labor could take under
the Occupational Safety and Health Act. Thus, foi- example, the Ad-
ministrator of EPA could not, under section 6(a)(8) require that
a substance be labeled so as to prescribe requirements for its safe
and healthful use which apply solely to workers in their place of
employment. The Department of Labor, pursuant to tlie Occupational
Safety and Health Act of 1970, already has autliority to prescribe
safe and healthful working conditions. Similarly, section 6(b)(2)
shall not be construed to allow the Administrator of EPA to establish
occupational safety and health standards.'*

KsrpJanation. — The clarification to paragraph 6(a)(2), together
with the addition of legislative history with respect to paragraphs
6(a) (3) and 6(b) (2), will assist in implementation of the bills policy
to "complement and supplement'' existing authority. These changes
will assist in avoidin£T overlap between EPA and the Department of
Labor's workplace safety and health authority.

b. Page 18. line 17. page 20, line 23, page 21. lines 6 and 12, delete
"adulterated" (or "adulteration") and insert in lieu thereof "con-
taminated" (or "contamination'').

Explanation. — AVe belicA'e that the term "contaminated" (or "con-
tamination") would more clearly express the intent of these provi-
sions instead of "adulterated" which is often understood or defined as
an intentional act.

c. Page 19, lino 1 1. delete entire paragraph (3).

Explanation. — AVe believe that the Administrator should not be-
come involved in assigning quotas to industry. The mandatory require-
ment of a quota system would make the reo:ulatory process vastl / more
CTunbei'some and difficult to administer. The Act already provides that
when it is necessary to adopt a rule with respect to a chemical sub-

482

stance to protect against an unreasonable risk, the Administrator shall
select the least stringent requirement practicable consistent with pro-
tection of the health and the environment. It is expected that the es-
tablishment of quotas would seldom, if ever, be necessary as such
would be a most stringent requirement. Nevertheless, we strongly rec-
ommend against becoming involved in the establishment of quotas,
d. Page 20, after line 15, insert the following :

"(4) the economic impact of such action, including, but not limited
to. consideration of the effects on business, employment, and the na-
tional economy.'"

Explanation. — This amendment would specifically require the Ad-
ministrator to consider economic impact in promulgating regulations,
already inherent in the requirement that he consider all relevant fac-
tors. This would be in lieu of proposals that have been made for the
mandatory preparation of detailed economic impact statements for
issuance at the time any regulation is promulgated.

5. Suits hy U.S. attorneys instead of hy Achninistrator

Page 22, line 17, delete all after "may" through "so,", line 19 and
insert in lieu thereof :

"request a United States Attorney to petition an appropriate dis-
trict court of the United States".

Page 39, line 3, delete "Administrator or the".

Page 46, line 7, delete "Administrator (or Attorney General on his
behalf) " and insert in lieu thereof "Attorney General".

Page 46, line 8, after "commenced" delete "and is diligently prose-
cuting" on lines 8 and 9.

Explanation. — These amendments would carry out the long-time
policy of having the Justice Department responsible foi- litigation in-
stead of each Agency. In the citizen suit provisions, we believe that it
is sufficient if the Attorney General has commenced an action and that
it is not necessary to impose a further requirement that he be dili-
gently prosecuting it, a concept which is at best difficult to litigate and
at worst could lead to counter-productive court action.

6. Submission of records; health and safety studies

a. Page 25, line 3, add at end of sentence :

"The Administrator may require copies of such records pursuant to
his responsibilities under sections 4, 5, 6, and 7 of this Act."

Explanation. — While the bill provides that records of adverse
health effects caused by chemical substances are required to be main-
tained, no provision is made to require submission of such records.
This amendment would correct that omission.

b. Page 25, line 4, delete subsection (e) and insert in lieu thereof:
"(e) Healtli and Safety Studies. The Administrator shall promul-
gate regulations undei- whirh he may require any person who manu-
factures, processes, or distributes in commerce any chemical substance
(or with respect to paragraph (3), any person who has possession of
a study) to submit to him —

"(1) Lists of health and safety studies in })io<rress on or ini- ,
tiated after the date of enactment of this Act, conducted by or '
for such person, or known to such person ;

483

" (2) Lists of health and safety studies conducted by or for such
person, or known to have been made by any person, prior to the
date of enactment of this Act ;

"(3) Copies of any such studies appearing on a list submitted
pursuant to paragraphs (1) or (2), or otherwise known by him."
Explaimtion. — This amendment would revise the provision requir-
ing industry to report on or submit all health and safety studies. It
would require submission of lists of on-going and new studies rather
than the study, witli a right to require submission of studies. It
would authorize the Administrator to nrovide by regulation for the
types of studies to be included on the lists, and the number of years of
prior studies for particular types of studies; and would require a per-
son to also list studies which he knows are being made or have been
made.

7. Additional exem'ptioiis ; additional limitation cm authority

a. Page 26, line 8, delete "or"; line 10, after "Act)" insert a comma
and add "cosmetics (as such term is defined in section 201 (i) of the
Federal Food, Drug, and Cosmetic Act),"; line 18, replace the period
with a semicolon, and add the following :

"(3) any source material, special nuclear material or byproduct
material as defined in the Atomic Ener^irv Act of 1^54 (42 U.S.C.
2011), as amended, and regulations issued pursuant thereto; or

"(4) tobacco and tobacco products."

Explanation. — We believe that cosmetics should also be exempted
and materials regulated under the AEC Act, and do not believe that
tobacco and tobacco products should be regulated under the Toxic
Substances Control Act.

b. Pasfe 26, after line 18, add new subsection (b) as follows, and
renumber other subsections accordingly :

"(I)) Notwithstanding any provision of this Act, the Administrator
shall have no authority under se'^tions 6 and 7 of this Act to take any
action which the Secretary of Labor is authorized to take pursuant
to the Occupational Safety and Health Act. In exercisinir authority
pursuant to this Act, the Administrator shall not, for the purnoses
of applying section 4(b)(1) of the Occupational Safety and Health
Act, be deemed to be exercising statutory authority to prescribe or
enforce standards or regulations affecting occupational safety and
health."

Explanatloi-i. — The purpose of these changes is to eliminate the
possibility of jurisdictional conflicts between EPA and the Depart-
• ment of Labor where actions taken by one authority might otherwise
preclude or duplicate action of the other.

S. Interagency cooperation, and coordination

Paofe 3. after line 17, add the following new paragraph :
. "(5) such authority over chemicals be exercised in such a manner
I as to complement and supplement existing Federal policies, regula-
tions, and public laws regarding the protection of health and the en-
vironment, including occupational health, consumer safety, food, drug,
and cosmetic authorities."

Page 28, line 3, delete the sentence after "coordination. — " and
insert in lieu thereof :

484

"In administering the provisions of this Act, the Administrator shall
consult and coordinate with the relevant aj^encies and instrumentali-
ties of the Federal Government in accordance with the policies set
forth in section 2 (b) of this Act."

Pa^e 80, line 2, delete the last sentence of subsection (a) and insert
in lieu thereof :

"The Administrator is authorized to make contracts and grants for
research and monitoring as necessary to carry out the purposes of this
Act in consultation with the Secretary of Health, Education, and Wel-
fare on such contract and grant programs."

Page 30, line 7, delete entire subsection (b) and insert new sub-
section (b) as follows :

"(b) The Council on Environmental Quality in consultation with
the Administrator, the Secretary of Health, Education, and Welfare,
the Secretary of Commerce, and the heads of other appropriate de-
partments or agencies, shall coordinate a study of the feasibility of
establishing (1) a standard classification system for chemical com-
pounds and related substances, and (2) a standard means for storing
and for obtaining rapid access to information respecting such mate-
rails. A report on such study shall be published within 18 months after
enactment of this Act."

Explanation. — These proposed amendments are intended to clearly
set forth that it is the policy of the Act that there be the maximum
cooperation and coordination among the several agencies of the Fed-
eral Government which have programs and responsibilities concerned
with toxic substances; that the Act is intended to complement and
supplement existing laws and regulations such as the Federal occupa-
tional health and safety requirements ; and that appropriate provisions
are made to establish and to have access to information relating to
chemical compounds.

A number of Federal agencies, particularly the Occupational Health
and Safety Administration of the Department of Labor have exten-
sive responsibilities relating to toxic substances and human health and
would stand to benefit from various provisions of the Act. The testing
of chemicals as they relate to the programs of these agencies and the
test results and other information and data generated by the legisla-
tion would, of course, be valuable to them and must be made available.

One of these amendments specifically provides that the EPA Ad-
ministrator will consult with the Secretary of Health, Education, and
Welfare on any contract and grant programs for carrying out the re-
search and monitoring activities under the Act, but not necessarily
on each individual contract or grant.

We are also recommending that the provision contained in the previ-
ous bills before the Congress directing the Council on Environmental
Quality to coordinate a study on the feasibility of establishing a stand-
ard classification system for chemical compounds and means of ob-
taining rapid access to the information on such substances be restored
to the Act. This section provides CEQ to have the lead in establishing
information systems in a manner currently being initiated. This is
beins: done in conjunction with the agencies that would have been
represented on the interagency committee as set out in the provision
proposed to be deleted.

485

9. Additional assistant administrator

Page 28, line 15, delete subsection (a), renumber subsections (b)
and (c) accordingly.

Explanation. — This amendment would delete the provision for a
special category Assistant Administrator for Toxic Substances.

10. Administrative inspections

Page 31, line 6, insert "(a)" after "Sec. 12", and after line 21 insert
new subsection (b) :

"(b) Notwithstanding the provisions of subsection (a), the Ad-
ministrator shall have authority to inspect financial data records per-
taining to testing costs when he orders contribution or reimbursement
for the costs of performing tests in connection with the provisions of
sections 4(c) and 5(f)."

Explanation. — Sections 4(c) and 5(f) authorize the Administrator
to determine the equitable contribution or reimbursement of testing
costs where more than one person benefits from the testing. This
amendment would authorize access to financial data on testing costs in
order for the Administrator to carry out the requirement to apportion
the costs among those benefiting from the testing.

11. Disclosure of confidential information

Page 34, line 18, delete entire section 15 and insert in lieu thereof
the following revised section :

"confidentiality

"Sec. 15. (a) General. — Any information reported to, or otherwise
obtained by, the Administrator or his representative under this Act,
which is exempt from mandatory disclosure by reason of section 552
(b) (4) of title 5, United States Code, shall be entitled to confidential
treatment and shall not be disclosed by the Administrator or by any
officer or employee of the United States, except that such information
may be disclosed —

"(1) to officers and employees of the United States in connec-
tion with their official duties ;

"(2) to contractors with the United States and employees of
such contractors, if in the opinion of the Administrator such
disclosure is necessary for the satisfactory performance by the
contractor of a contract with the United States entered into on
or after the effective date of this Act for the performance of work
in connection with this Act ;

"(3) when relevant in any proceeding under this Act, except
that disclosure in such a proceeding shall be made in such manner
as to preserve confidentiality to the extent practicable without
impairing the proceeding; or

"(4) to the extent that the Administrator determines it is nec-
essary to protect health or the environment.
"(b) Access by Congress. — Notwithstanding any limitation con-
tained in subsection (a) or any other provision of Jaw, all information
reported to or otherwise obtained by the Administrator or his repre-
sentative under this Act shall be made available upon written request
of any duly authorized committee of the Congress.

486

719

"(c) Criminal Penalty for Wrongful Disclosure. — (1) Any offi-
cer or employee of the United States, or former officer or employee of
the United States, who by virtue of his employment or official posi-
tion has obtained possession of, or has access to, material which is
entitled to confidential treatment under subsection (a), and who
knowing that disclosure of the specific material is prohibited by this
section, willfully discloses the material in any manner to any person
not entitled to receive it, shall be guilty of a misdemeanor and fined
not more than $5,000.

"(2) For the purposes of this subsection (c), any contractor with
the United States who is furnished information pursuant to subsec-
tion (a) (2), and any employee of any such contractor, shall be con-
sidered to be an employee of the United States."

Explanation. — This section should be amended in several respects.
First, the substantive criterion for withholding data as confidential
should be the test established by the Freedom of Information Act,
5 U.S.C. 552(b) (4). Our proposed amendment would have the effect
of requiring nondisclosure of information obtained under the Toxic
Substances Control Act which may be withheld under 5 U.S.C. 552
(b)(4), i.e., "trade secrets and commercial or financial information
obtained from a person and privileged or confidential." This will
make the confidentiality standard more definite (because there exists
a body of case law interpreting 5 U.S.C. 552(b) (4)), and will pro-
mote uniformity.

In addition to the exemption for disclosure to Federal officers and
employees, a separate provision should allow disclosure to EPA con-
tractors and their employees, under appropriate safeguards and after
appropriate EPA findings that disclosure is necessary. EPA accom-
plishes a great deal of its investigatory and analytical tasks by con-
tract. If contractors are not allowed access to information under this
bill, EPA could not perform its duties satisfactorily without sub-
stantial manpower increases. The recently-enacted Privacy Act, 5
U.S.C. 552a, provides that, for purposes of the section of the Privacy
Act which imposes penalties on Government employees for wrongful
use or disclosure of information entitled to confidentiality. Govern-
ment contractors and their employees are to be considered Government
employees (5 U.S.C. 552a (m)). We recommend inclusion of such a
provision in the toxic substances proposed bill. Our amendments allow
disclosure to contractors, and include a penalty for wrongful disclo-
sure of information by Government employees (including contractors
and their employees) .

We also believe that the provisions relating to qualified scientists
and individual names are not necessary. The term "qualified scientists"
would be difficult to interpret, and in any event a scientist would have
no greater rights under the subsection than would any person under
our (proposed) bavsic confidentiality criterion. We believe that the
Federal Privacy Act and the Freedom of Information Act provide
ample protection of the rights of individuals whose names appear in
health and safety records.

Finally, with regard to access of information by Congress, we be-
lieve that release of such confidential information should be upon
written request.

487

12, State exemption from Federal preemption
Page 42, line 14, delete subsection (b) .

Explanation. — This amendment would delete the provision that
would allow State and local governments to petition to be exempted
from Federal preemption requirements.

13. Citizen suits for discretionary action

Page 45, line 13, delete language after "Act" through line 16, and
insert in lieu thereof :

"which is not discretionary with the Administrator.".

Explanation. — This amendment would make the provision conform
with the usual citizen suit provision and not authorize suits against
the Administrator for discretionary acts. It would thus prevent the
possibility of every decision of the Administrator from being re-
decided in tlie district courts.

H, Indemnification study

Page 52, line 17, delete all of section 25 and renumber section 26
accordingly.

Explanation. — This amendment would delete the requirement for
a study on Federal indemnification under laws administered by EPA.
AVe believe sufficient information already exists to recommend against
indemnification under programs administered by EPA.

15. /Submissions of budgets and testimony to Co^igi^ess
Page 54, line 15, delete all of subsection (c).

Explanation. — This amendment would delete the requirement ihat
Agency budget letjuests, testimony and comments on legislation must
not be submitted to OMB prior to submission to Congress. We con-
tinue to object to this provision.

IG. Additional miscellaneovs amendments

Page 2, line 16, add after "substances": "which may present an
unreasonable risk to health or the environment".

Page 3, line 8, insert after "to" the following: "ensure that adequate
testing is conducted by those persons who manufacture, import or
process, too".

Page 5, line 17, after "ecological studies" insert "monitoring
studies,".

Page 8, line 4, delete "proscribed" and insert "prescribed".
Page 8, line 20, insert after "that" "one or more of the following".
Page 8, line 24, insert after "synergistic properties," "persistence,".
Page 10, line 6, delete "section 5(g)" and insert "section 5(f)".
Page 22, line 12, delete "any".

Page 22, line 13, delete "threat" and insert in lieu thereof "risk".

Page 29, line 15, delete the period and add "if appropriate.".

Page 33, line 20, delete "delivery" and insert in lieu thereof "re-
lease"; line 22, delete "three months" and insert in lieu thereof "90
days"; and on line 25, delete "delivery" and insert in lieu thereof
"release".

Page 34, line 1, after "decision" insert "by the Administrator"; line
4, delete "article, together with the" and insert in lieu thereof "article
as set forth in the Customs entry plus the estimated" ; line 5, delete

488

"forfeiture of" and insert in lieu thereof "liability for assessment of
liquidated damages equal to"; line 6, delete "refusal" and insert in
lieu thereof "failure"; line 10, delete "delivery" and insert in lieu
thereof "release"; line 11, insert a comma after "payment" and delete
"of" and the comma after "charges" ; and on line 16, delete "of sub-
section (a)".

Page 39, line 5, "section 17," should read "section 16,".
Explanatimi. — These amendments are technical corrections or are
otherwise self-explanatory.

U.S. Environmental Protection Agency,

Washington^ D.C.^ February 5, 1976.

Hon. Harley O. Staggers,

Chairman^ Committee on Interstate and Foreign Commerce^ House
of Representatives^ Washington^ B.C.

Dear Mr. Chairman : On November 13, 1975, Mr. James T. Lynn,
Director, Office of Management of Budget advised Congressman
McCollister of your Subcommittee on Consumer Protection and Fi-
nance that the Administration had reassessed its previous position
with regard to the toxic substances control legislation and would sup-
port H.R. 7664 with some modification.

Enclosed are the Administration's proposed amendments for modi-
fying H.R. 7664. The enclosure summarizes several of the more sig-
nificant proposals to amend H.R. 7664 and contains all of the proposed
amendments and a brief explanation of each.

These proposed amendments to H.R. 7664 were jointly developed
with the other concerned Federal departments and agencies and rep-
resent the views of the Administration on the toxic substances con-
trol legislation.

With the favorable consideration of these proposed amendments we
would urge the enactment of H.R. 7664.
Sincerely yours,

Russell E. Train, Administrator.

Enclosure.

Proposed Amendments to H.R. 7664, the "Toxic Substances
Control Act of 1975" by Mr. McCollister

Summarized below are several of the significant proposals to amend
H.R. 7664. A number of other amendments have also been developed
which would improve the effectiveness of the bill. All of the proposed
amendments are set out and explained in the pages following this
summary.

definitions

We are proposing that the definition of "chemical substance" be
amended to provide the Administrator with some flexibility to exclude,
in appropriate situations, certain substances from the definitions and
thus from the requirements of the Act or from particular provisions of
the Act, It would be almost impossible to draft the bill to exempt
certain substances from the Act or, as more likely the case, from cer-
tain provisions of the Act in each situation where such is appropriate.

489

Scientific laboratory reagents are an example. Here it may Very well
be appropriate to exclude such products from the testing and regula-
tory provisions, but not necessarily the reporting and adverse effects
provisions when they are used by certain research or scientific labora-
tories; on the other hand, we would not likely wish to exclude high
school laboratories from any labeling requirements. An exclusion may
also be in order for a substance not manufactured in commercial quan-
tities. An excessive burden and inconvenience to the industry or the
user would be averted with this flexibility in the Act.

TESTING

There is a provision in the testing requirement of the bill that we
foresee as an undue burden upon the Administrator. AVhile we agree
that provision should be made for the sharing of testing costs in the
event that there is more than one manufacturer of a substance for
which testing is required, we are very reluctant to become involved in
designating which manufacturer (or possibly a third party) should
conduct the tests if the parties cannot reach an agreement. We are
therefore recommending deletion of the provisions authorizing the
Administrator to designate which party should do the testing.

We are also proposing: that tlie criterion by which the Administrator
would require testing be revised so as to authorize the requirement
when a chemical mav pose an unreasonable risk to health or the
environment, rather than when "necessarv to protect against unrea-
sonable risk to health or the environment''. When the latter positive
situation occurs, presumably the Administrator would take action
under section 6.

PREMARKET NOTIEICATION

Section 5 of H.K. 7664 provides that within eighteen months after
enactment of the Act the Administrator shall by rule compile a list
of chemical substances (or chemical substances with respect to a par-
ticular use or uses) which the Administrator finds are likely to pose
substantial danger to health or environment. Substantial danger to
health or the environment is defined to mean an unreasonable risk of
death, or widespread or severe personal iniury or illness, or of wide-
spread or severe harm to the environment. If a new chemical substance
or a significant new use of a chemical substance is on the list, the Ad-
ministrator would receive 90 days premarket notification from the
manufacturer or processor. The substantial danger test above is so
strict that it would place an impossible burden on the Administrator
to know or predict in advance when such a new chemical or new use
will come about, and any substance placed on the list would almost
certainly be subject to the imminent hazard prov^isions of section 7
upon manufacture. We are proposing instead an "unreasonable risk"
standard for promulgating the list. This would not have the defects
outlined above and would focus premarket notification on harmful
chemicals and not require notification on all new substances.

QUOTAS

An amendment is being proposed to the quota provisions of H.R.
7664 to provide cooperative action with the Secretary of Commerce

79-313 0 - 77 - 32

490

«3

where quotas have to be established. The Act provides that when it is
necessary to adopt a rule with respect to a chemical substance to pro-
tect against an unreasonable risk, the Administrator shall select the
least stringent requirement practicable consistent with protection of
health and the environment. Restrictions limiting the amount of a sub-
stance that may be manufactured would be the most stringent require-
ment, other than a total ban, and the establishment of quotas would
seldom be necessary. However, in the event quotas have to be estab-
lished we recommend that the Secretary of Commerce be involved in
setting them.

ECONOMIC IMPACT

H.R. 7664 would require that the Administrator consider a number
of relevant factors in promulgating rules with respect to a chemical
substance. We are proposing that a specific provision be added that
he also must consider the economic impact of such action, including,
but not limited to, consideration of the effects on business, employ-
ment, and the national economy. Consideration of these factors is
already inherent in the requirement that he consider all relevant
factors. We suggest this amendment in lieu of the mandatory prepara-
tion of detailed economic impact statements at the time a regulation
is promulgated and suggest the economic impact statement provision
be deletedc

REPORTIXG INITIAL MANUFACTURE

We propose to amend the provisions requiring manufacturers, im-
porters, and processors to make reports to the Administrator so as to
give the Administrator the authority to require when appropriate
that the manufacturer of a new chemical substance submit a report on
that substance on the day its manufacture for commercial purposes
begins. Only by this means will the Administrator be able to maintain
a complete inventory of chemical substances. An inventory^ is necessary
if the Administrator is to have any idea what chemicals are being
marketed and which may need to be regulated.

HEALTH AND SAFETY STUDIES; ADVERSE REACTIONS

We are proposing that a provision be added to the reporting section
requiring the submission of lists of health and safety studies. The
amendment would require submission of lists of on-going and new
studies, rather than the study, with a right to require the submission
of a given study. It would authorize the Administrator to provide by
regulation the types of studies to be includued on the lists and the
number of years for which prior studies must be listed. The amend-
ment would also provide that a person would list studies which he
knows are being made or have been made. We are also suggesting a
provision be added to the reporting section requiring records of ad-
verse reactions to human health or the environment be available for
submission to the Administrator at his request.

SMALL BUSINESS EXEMPTION

We recognize that there may be a need due to a financial burden
for exempting some small businesses from some of the reporting re-

491

quirements of the Act. At the same time, some businesses manufac-
ture such toxic substances that they need to be regulated no matter
how small they are. Therefore, we propose an amendment which pro-
vides the Administrator with authority to exempt a small business
concern from the reporting provisions for reasons of undue financial
burden but requires the report of initial manufacture and prohibits
exemption where a chemical substance may present an unreasonable
risk to health or the environment, making it subject to sections 4(a)
(testing), 5(a) (list of "risk'' chemicals), or 6(a) (regulation of
"risk" chemicals). The Administrator is required to consult with the
Administrator of the Small Business Administration in defining
"small business concern''.

RELATIONSHIP OF OTHER LAWS

The bill would in some instances provide authority to regulate
toxic chemical substances which it may be possible to regulate under
a law administered by another agency. When this occurs, there is
the question of which authority should govern. We propose that au-
thority not be exercised under section 6 (regulation of chemicals)
and section 7 (imminent hazards) where action is more appropriate
under the law of some other agency. Other agencies would be re-
quested by the Administrator to determine if a risk is presented or is
likely to be presented by a chemical substance or mixture, and if such
risk can be prevented or reduced to a sufficient extent by actions under
their law. The agencies would then either determine that the substance
or mixture does not pose or is not likely to pose an unreasonable risk
to health or the environment or initiate action to protect against such
a risk.

Questions which could occur over the validity of actions taken
under the Toxic Substances Control Act where other authorities
exist would be avoided under this amendment.

EXEMPTIOX FROM FEDERAL PREEMPTI(>X

We do not recommend the provisions of H.E. 7664 which would
allow State and local agencies to petition the Administrator for exemp-
tion from the Federal preemption requirements. State and local agen-
cies would be allowed to. regulate any toxic substance until such time
as the Administrator puts into effect regulations for testing or re-
stricting a substance. Thereafter, they could impose only a total ban
on a substance. In view of the fact that the bill authorizes the Ad-
ministrator to regulate with respect to geographic areas there would
appear to be no need for a State or local agency to duplicate any
regulations with respect to a substance after Federal regulations are
in effect.

Proposed Amendments to H.R. 7664, the Toxic Substances Control

Act

AUTHORiry to exempt IN DEFINITION

Page 4, line 2, delete the period after "mixture" and insert a semi-
colon and the following :

492

"Provided, however, the Administrator may by regulation exclude
from this definition as it applies to this Act, or to any provision of
this Act, certain categories of chemical substances, including laboratory
reagents, catalysts, selected mixtures, and chemical substances not
manufactured in commercial quantities."

Explanation. — This amended definition of a "chemical substance"
would provide the Administrator with flexibility to exclude, in ap-
propriate cases, a substance from the requirements of the Act, or
from a particular provision (not already excluded) where such sub-
stance does not need to be regulated, cannot be effectively regulated,
or where meeting the requirements might be an undue burden.

NEW CHEMICAL SUBSTANCES

Page 4, after line 19, insert the following as paragraph (8) and
renumber paragraph (8) as paragraph (9).

"(8) The term "new chemical substance" means any chemical sub-
stance not included in the inventory of chemical substances compiled
and published under section 8(b)."

Explanation. — H.R. 7664 needs to be modified to ensure that the
Administrator may issue a requirement for rej)ortingof "new chemical
substances" at the time of manufacture. A "new chemical substance"
can be defined by reference to the inventory of all existing chemical
substances to be published by EPA according to section 8(b) as
amended.

TESTING SECTION 4

1. Standards for Test Protocols

a. Page 6, line 17, change title of section 4 to "STANDARDS
FOR TEST PROTOCOLS"

Expla7iatioii. Conforming amendment (see Explanation in b.
below).

b. Page 6, lines 18-25, delete all of subsection (a) and insert in lieu
thereof the following:

Section 4. (a) If the Administrator determines that —

(1) the manufacture, distribution in commerce, process-
ing, use or disposal of a chemical substance may pose an un-
reasonable risk to health or the environment ; and

(2) that testing such chemical substance is necessary to
detremine whether an unreasonable risk to human health
and the environment does or does not exist; then he may,
by rule, prescribe standards for a test protocol for such sub-
stance, and require, in accordance with subsection (d), that
one or more persons formulate a test protocol for such sub-
stance in accordance with such standards, and perform the
tests required by such protocol.

Explanation. — If the Administrator could demonstrate that test-
ing is "necessary to protect against unreasonable risk to health or
the environment" (H.R. 7664), presumably he could take restrictive
action under section 6. The revised section 4(a) is a far more appro-
priate^ determination for issuing a testjjig requirement in that it

493

reflects the unceitainty of the risk that would prompt the Adminis-
trator to require testing.

The revised language permits the Administrator to prescribe the
standards for a test protocol rather than the protocol itself, which
would be developed by the affected manufacturer in accordance with
the standards. The advantage is flexibility, in that the protocol can
be more closely tailored to the chemical substance and the questions it
poses; and through standards the Agency can require results of test-
ing rather than specific testing methods.

In addition, instead of being required in each instance to follow
narrowly defined procedures for testing, the industry should have
the flexibility when appropriate to develop efficient test protocols
in accordance with the Administrator's standards.

c. Page 7, line 9 to 14. Delete lines 9 to 14 and insert in lieu thereof
the following:

(3) the extent to which testing of such substance may re-
sult in the & ^lopment of data upon which the effects of
such substance or mixture on health or the environment can
reasonably be determined or predicted:

(4) the existence of data concerning the effects of the
chemical substance or mixture on health or the environment ;
and

Explanatio)!. — These two amendments do not alter the intent of the
original provisions but conform the language to the use of "standards
for tCvSt protocols" instead of "test protocols."

d. Page 7, line 21. Delete line 21 through "tests" and substitute
the following:

PJorpJanation. — It is necessary to make clear that standards for
test protocols do not necessarily entail development of specific test
protocols but rather methodologies or guidelines for development of
test protocols. It is also necessary to make clear that the test protocol
is not limited to those tests specifically named.

e. Additional confoi-ming amendments to sections 5 and 8.

Page 11, line 14: delete "in accordance with a test protocol" and
insert in lieu thereof "under a test protocol, in accordance with
standards".

Page 11, line 15: insert a comma after "4".

Page 12, line 1: delete "in accordance with a test protocol" and
insert in lieu thereof "under a test protocol, in accordance with
standards".

Page 12, line 2 : insert a comma after "4".

Page 12, line 11: insert "standards for a" after "applicable".

Page 12, line 12: delete "has" and insert in lieu thereof "have".

Page 12, lines 13 and 17-18: insert "standards for" before "a test
protocol".

f. Additional conforming amendments to section 3, DEFINI-
TIONS :

Page 5. lines 3-16, definition of "test protocol": delete the dash on
hne 3 and subparagraph heading "(A)" on line 5; delete the comma

494

at the end of line 9 and insert in lieu thereof a period ; and delete lines
10-16.

Page 4, line 23 : insert a new paragraph after new paragraph (9)
as follows and renumber subsequent paragraphs accordingl Vi :

(10) the term "standards for a test protocol" means stand-
ards prescribing the nature and quality of a test protocol,
including :

(A) the manner in which test protocols are to be developed
to determine the human health and environmental effects of a
chemical substance,

(B) any analysis that is to be performed on test data de-
veloped, and

(C) any requirements to be met in the design of any test
protocol necessary to insure the reliability and adequacy of
test data developed.

2. Designating who should perform testing

Page 8, line 11, delete the last sentence in paragraph (d) beginning
with "If" through line 21, and insert in lieu thereof :

If such an arrangement is made the Administrator shall be
notified and the remaining such persons shall be exempted
from requirements to perform tests.

Explanation. — AVe do not believe that the Administrator should be-
come involved in designating which party (or a third party) should
perform tests if the parties cannot agree among themselves. If a cost-
sharing arrangement is made for one of the parties to do the testing,
however, provision should be made to exempt the other parties from
the testing requirements.

S. Timely submission of test data.

Page 8, line 22: delete section (e) and insert in lieu thereof:

(e) Any manufacturer, processor, or importer who is re-
quired to perform the tests called for in a test protocol under
this section shall promptly transmit to the Administrator
the test data developed pursuant to such test protocol.

Explanation. — This amendment Avill ensure that the test data shall
be promptly transmitted to the Administrator after completion.

PREMARKET NOTIFICATION LIST

a. Page 10, line 1, Section title, after "SCREENING", delete re-
mainder of section title.

b. Page 10, line 8, after "finds", delete remainder of paragraph
through line 13, and add in lieu thereof the following :

may pose an unreasonable risk to health or the environment.

c. Page 15, line 13, after "substances", delete "as likely to pose sub-
stantial danger" and add in lieu thereof "which may pose an unreason-
able risk".

Explanation. — The substantial danger test in the current provision
is so strict that no substance would be placed on the list unless at the
same time it was subject to regulations applicable to a Hazardous

495

Chemical Substance under section 6 and an Imminent Hazard under
section 7. The proposed "unreasonable risk" standard for the list
would focus premarket notification on harmful chemicals and not re-
quire notification on all new substances.

AMENDMENTS TO SECTION 6 — REGULATIONS

1. Assigning Quotas

Page 18, line 13, delete "uses, shall include provision for" and insert
in lieu thereof "uses shall be prescribed by the Administrator in con-
sultation with the Secretary of Commerce. The Secretary of Com-
merce in consultation with the Administrator shall by rule provide
for".

Page 18, line 14, after "quotas" add "to the extent necsssary".

Page 18, line 19 and 20, delete "The Administrator shall by rule pre-
scribe criteria which" and insert "Such criteria".

Page 18, line 22, after "the" delete "market shares, productive ca-
pacity," and insert "current and past market shares, productive ca-
pacity, captive consumption,".

Explanafio)}. — This amendment is being proposed to the quotas
provisions of H.R. 76fU to provide cooperative action with the Secre-
tary of Commerce where quotas have to be established. The Act pro-
vides that when it is necessary to adopt a rule with respect to
a. chemical substance to protect against an unreasonable risk, the
Administratoi- shall select the least stringent requirement practicable
consistent with protection of health and the environment. Restrictions
limiting the amount of a substance that may be manufactured would
be the most stringent requirement, other than a total ban, and the
establishment of quotas would seldom be necessary. However, in the
event quotas have to be established we recommend that the Secretary
of Commerce be involved in setting them.

2. Economic Imjyact Analysis

Page 19, line 11: delete "and"; Page 19, line 13: delete the period
and insert in lieu thereof: "; and"; Page 19, after line 13: add a new
subparagraph 4 as follows:

(4) the economic impact of such action, including but not
limited to, consideration of effects on business, employment,
and the national economy.

Page 21, line 21 : delete all of subsection (g) .

ExpJanatio)i. — This amendment would specifically require the Ad-
ministrator to consider economic impact in promulgating regulations,
already inherent in tlie requirement that he consider all relevant fac-
tors. This would be in lieu of the mandatory preparation of detailed
economic impact statements for issuance at the time any regulation is
required, wliich provision is deleted by the amendment.

AMENDMENTS TO SECTION 8, REPORTS

/. Reporting Initial Manufacture

a. Page 24, line 23, after "any" insert "person who is a".

b. Page 24, line 25 — page 25, line 1 : delete "and at such more fre-
quent time" and insert in lieu thereof "or such times".

496

Explanation, — Authority should be provided in the legislation en-
abling the Administrator to learn of the existence of a new chemical
substance as soon as manufacture begins. This is minimal authority,
intended to inform him of the initiation of the manufacture of a new-
chemical substance. Therefore, the amendment authorizes the Admin-
istrator to require of a chemical manufacturer that he initially reports
on the day on which manufacture of a new chemical begins and pro-
vides the other specified information. This amendment would also
permit the reporting time in periods useful to the Administrator and
geared to the different types of reports which he has authority to
request. Such periods may be more or less frequent than one year.

2. Reporting Adulteration

Page 25, line 16 : Between lines 16 and 17 insert a new subparagraph
(E) as follows, and renumber subsequent subparagraphs accordingly :

(E) Records pertaining to quality control procedures and
adulteration as defined in subsection 6(e).

Explanation. — While subsection 6 (e) authorizes the Administrator
to require a manufacturer or processor to submit a description of qual-
ity control procedures, there should be additional authority to obtain
records pertinent to such procedures, such as those demonstrating
the procedures are being followed, and to incidents of adulteration.

3. Reporting Health and Safety Studies: Adverse Reactions

Page 25, line 1, after "require," insert "on any chemical substance
manufactured, imported, or processed,".
Page 25, after line 21, insert the following :

(G) Health and safety information including:

(i) lists of health and safety studies in progress on
or initiated after the date of enactment of this Act, con-
ducted by or for such person, or known to such person ;

(ii) lists of health and safety studies conducted by
or for such person, or known to have been made by any
person, prior to the date of enactment of this Act ;

(iii) at the request of the Administrator, copies of
any sucli studies appearing on a list submitted pursuant
to paragraphs (i) or (ii), in the possession or control of
such person.

(H) Records of adverse reactions to human health or the
environment or adverse results in health and safety studies
known or alleged to have been caused by the chemical sub-
stance. Sucli records may consists of, but not be limited to,
consumer allegations of 'personal injury or harm to health,
reports of occupational disease or injury, and reports of com-
plaints of injury to the environment submitted to the person
by individuals or governmental agencies. The Administrator
may require copies of such records pursuant to his responsi-
bilities under sections 4, 5, 6, and 7 of this Act.

Explanation.— The proposed amendment would require the sub-
mission of lists of health and safety studies and would require sub-
mission of lists of on-going and new studies rather than the study
itself with a right to require the submission of a given study. It would
authorize the Administrator to provide by regulation the types of

497

studies to be included on the lists and the number of years for which
prior studies must be listed. The amendment would provide that a per-
son would list studies which he knows are being made or have been
made. The amendment also provides that records of adverse reactions
to human health or the environment be available for submission to the
Administrator at his request.

4. Exemptions from Reporting Requirements

a. Page 24, lines 22 and 23 : delete ''Except as provided in subsections
(b) and (c), the'' and insert in lieu thereof ''The''.

b. Page 26, line 6: after line 6, insert a new paragraph (4) as
follows :

(4) (A) The Administrator may, by rule, exempt from or
modify for any manufacturer, importer, or processor who is
a small business concern all or part of the reporting require-
ments of this section where such requirements would cause
an undue financial burden on such small business; provided,
however, no exemption or modification shall be authorized
until after the initial reporting is made under this section and
such exemption or modification shall discontinue when there is
a significant change in the amount of the substance manufac-
tured, imported or processed from the amount last reported.

(B) No exemption or modification of reporting require-
ments shall be authorized under paragraph (4) (A) with re-
spect to a chemical substance or an article containing such
substances —

(i) for which a testing re([uirement has been pre-
scribed under section 4(a) of this Act ;

(ii) which is contained in the list of chemical sub-
stances which the Administrator has by rule identified
and published in the Federal Kegister under section r)(a)
of this Act ; or

(iii) which is covered by a rule under section 6 of this
Act.

(C) For purposes of this subsection the Administrator shall
define a small, business concern, in consultation with the Ad-
ministrator of the Small Business Administration.

c. Page 27: Delete all of subsection (c) and renumber subsection
(d) as (c).

Explanation. — Subsection (b) of the existing H.I\. 7664 is a small
business reporting exemption provision. The amendment would elimi-
nate that blanket exemption and provide that there is authority to
exempt for reasons of undue financial burden. Subsection (c) of the
existing H.R. 7664 requires the Administrator to make specified ex-
emptions, an authority which is provided for in the amendment to the
definition of "chemical substances" at page 4, line 2.

5. Inventory

a. Page 26, line 7. delete entire section (b) and insert in lieu thereof:

(b) The Administrator shall compile, keep current, and
publish an inventory of each chemical substance which any
person reports under subsection (a) which is manufactured

498

or processed in the United States. A chemical substance shall
be included in such an inventory as of the earliest date (as de-
termined by the Administrator) on which such substance was
manufactured or processed in the United States.

Explanation. — Such an inventory would be useful to the Adminis-
trator in conducting his responsibilties under the Act.

RELATIONSHIP TO OTHER LAAVS

1. Page 28, after line 8 : insert a new paragraph (2) as follows, and
renumber subsequent paragraphs accordingly :

(2) any source material, special nuclear material, or by-
product material as defined in the Atomic Energy Act of
1954 (42 use 2011). as amended, and regulations issued pur-
suant thereto ;

Explanation. — The amendment adds a class of materials to the ex-
emption provision, as those materials are already adequately regu-
lated under existing law.

2. Page 28, line 24: delete all of subsections (b), (c), and (d) and
insert the following subsections in lieu thereof.

(b) Laws Not Administered by the Administrator :

(1) If the Administrator has reason to believe that the
manufacture, processing, distribution in commerce, use, or
disposal of a chemical substance or mixture poses or nmy pose
an unreasonable risk to health or the environment, and if
such risk may be prevented or reduced by action taken under
a law not administered by the Administrator, the Adminis-
trator shall request the agency which administers such law
(A) to determine if there is such a risk and (B) if the agency
determines that there is such risk to determine if such risk
may be prevented or reduced to a sufficient extent by action
taken under such law. Any such request shall be accompanied
by a detailed statement of the information on which it is
based. The agency receiving the request shall make the re-
quested determination within such time as the Administrator
specifies in the request, but such time specified may not be
less than ninety days from the date the request was made.
The report of an agency in response to a request made under
this paragraph shall be accompanied by a detailed statement
of the findings and conclusions of the agency respecting the
determinations requested to be made.

(2) If the Administrator makes a request under para-
graph (1) with respect to a chemical substance or mixture
and the agency to which such request was made either —

(A) determines that such substance or mixture does
not pose or is not likely to pose an unreasonable risk to
health or the environment, or

(B) initiates, within the time specified in the request
under paragraph (1) in response to such request, action
under the law (or laws) administered by such agency to
protect against such a risk,

499

the Administrator may not take any action under section 6 or
7 of this Act with respect to such substance or mixt ure.

(3) If the Administrator has initiated action under section
6 or 7 with respect to a chemical substance or mixture which
was the subject of a request made to an agency under para-
graph (1), such agency shall before taking action under the
law (or laws) administered by it to protect against such risk
to health or the environment associated with such substance
or mixture consult with the Administratoi* for the purpose of
avoiding duplication of Federal action against the risk.

(c) Laws Administered by the Administrator— The Ad-
ministrator shall coordinate actions taken under this Act with
actions taken under other Federal laws administered in whole
or in part by the Administrator. The Administrator shall use
the authorities contained in such other Federal laws to pro-
tect against any risk to health or the envii-onment associated
with a chemical substance or mixture unless the Administra-
tor determines that such risk may be more appropriately pro-
tected against under this Act. This subsection shall not be
construed to relieve the Administrator of any requirement
imposed on the Administrator by such other Federal laws.

(d) Occupatioiuil Safety and Health. — In exercising any
authority under this Act, the Administrator shall not, for
purposes of section 4(b)(1) of the Occupational Safety
and Health Act of 1970, be deemed to be exercising statutory
authority to prescribe or enforce standards or regulations
affecting occupational safety and health.

(e) Coordination. — In administering this Act. the Admin-
istrator shall consult and coordinate with the Secretary of
Health, Education, and Welfare and heads of any other ap-
propriate Federal executive department or agency, any rele-
vant independent regulatory agency, and any other appropri-
ate instrumentality of the Federal Government for the pur-
pose of achieving the maximum enforcement of this Act while
imposing the least burdens of duplication on those subject to
the Act and for other purposes.

Explanation. — The proposed amendment provides that the Admin-
istrator has no authority under section 6 (regulation of chemicals) and
section 7 (imminent hazards) if the following occurs. Other agencies
would be requested bv the Administrator to determine if a risk is pre-
sented or is likely to be presented by a chemical substance or mixture,
and if such risk can be prevented or reduced to a sufficient extent by
actions under another law. The agencies would then either determine
that the substance or mixture does not pose or is not likely to pose an
unreasonable risk to health or the environment or initiate action within
90 days to protect against such a risk. H.R. 7664 could presently be in-
terpreted so as to draw into question manv regulatory actions that
would be taken under the Toxic Substances Control Act. The commit-
ment of resources and protracted delays which could result from liti-
gation could undermine the implementation of this legislation and
seriously detract from effective use of this authority to protect health
and the environment.

500

ADVISORY PANELS |

Page 30, line 9 : delete all of section 10, Chemical Substances Board, i
and renumber subsequent sections accordingly. ;

Explanation. — The section would add a substantial administrative j
step to a comj^licated regulatory procedure, in that all rules to be \
proposed under sections 4, 5, and 6 (except in two specified instances)
would have to be presented to the Board for a scientific report. ;

There is. of course, a need for scientific advice. However EPA al- j
ready has a Hazardous Materials Advisory Committee fully qualified j
and able to advise on matters pertaining to toxic substances. The \
Agency program office would be staffed with a substantial number of •
qualified scientists. As with the Agency's Pesticide Program, the Ad- :
ministrator would draw on the many outside sources of advice in order i
to assure his decisions were soundly based in scientific knowledge, but |
as a matter of course in the normal rule-making process. The academic
community and sucli national groups as XAS, XSF. and XIH are
sources presently relied upon. In addition, EPA will submit its draft
regulations to other concerned agencies as a standard executive branch i
procedure to ensure adequate input botli of a scientific and substantive |
nature.

INSPECTION OF RECORDS FOR REIMBURSEMENT FOR TESTING |

Page 35 after line 2 insert new subsection (b) as folbQws and re-
number existing subsections (b) and (c) accordingly:

(b) Xotwithstanding the provisions of subsection (a), the
Administrator shall have authority to inspect financial data |
records pertaining to testing costs when he orders contribu-
tion or reimbursement for the costs of performing tests in j
connection with the provisions of section 5(f). ,!

Explanation. Section 5(f) authorizes the Administrator to deter- j

mine the equitable contribution or reimbursement of testing costs i!

where more than one person benefits from the testing. This amend- \

ment would authorize access to financial data on testing costs in order li
for the Administrator to carry out the requirement to apportion the
costs among those benefiting from the testing.

DISCLOSURE OF CONFIDENTIAL INFORMATION

Page 40, line 14, delete entire section 15 and insert in lieu thereof the
following revised section :

CONFmENTIALITY

Sec. 15. (a) General. — The use by any person to his own
advantage, or revealing, otlier than to the Administrator or
officers or employees of the Environmental Protection Agency
who have a need to know for the performance of theii- offi- |
cial duties, or to officers or employees of another Federal j:
agencv who have a need to know for the performance of their
official duties, or to the courts when relevant in any judicial

501

proceeding under this Act any information acquired pursuant
to this Act concerning trade secrets, information which is
likely to cause substantial harm to the competitive position
of the person submitting the information, or which would
likely impair the Government's ability to obtain necessary
information in the future is prohibited.

(b) Data from health and safety studies. — Subsection
(a) does not prohibit the disclosure of —

(1) any health and safety study submitted under this
Act with respect to —

(A) any chemical substance or mixture which on the
date the study is to be disclosed has been offered for com-
mercial distribution, or

(B) any chemical substance or mixture for which test-
ing is required under section 4 or for which notification
is required under section 5, and

(2) any data reported to, or otherwise obtained by the
Administrator from such a study.

This subsection does not authorize the release of data which
discloses processes used in the manufacturing or processing
of a chemical substance or mixture, or proprietary
formulations.

(c) Release of ixformatiox to coxtkactors. — (1) Not-
withstanding any limitation in subsection (a) such informa-
tion may be disclosed to contractors with the United States
and employees of such contractors if in the opinon of the Ad-
ministrator such disclosure is necessary for the satisfactory
performance by the contractor of a contract with the United
States entered into on or after the effective date of this Act
for the performance of work in connection with this Act.

(d) Crimixal pexalty for wroxgfil disclosure. — (1)
Any officer or em])loyee of the United States, or former officer
or employee of the United States, who by ])ossession of, or
who has access to, material which is prohibited from release
under subsection (a), and who knowing that disclosure of the
specific material is prohibited by this section, willfully dis-
closes the material in any manner to any person not entitled
to receive it, shall be guilty of a misdemeanor and fined not
more than $5,000.

(2) For the purpose of this subsection, any contractor with
the United States and any employee of any such contractor
who is furnished information pursuant to subsection (c) (1)
shall be considered to be an employee of the United States.

Exjylanation. — This section should be amended in sevei'al respects.
This legislation requires substantial information to be submitted to
the Government upon specific request of the Administrator. In addi-
tion, the legislation does not preclude voluntary submission of informa-
tion prior to or after manufacture. If individuals are not assured that
trade secret and confidential information as outlined in this section
will not be released except to authorized individuals it is highly likely
that information which the Agency could utilize would either be diffi-
cult to obtain in a timely fashion and/or simply not available. It is

502

95'

important, however, that all information obtained pursuant to the
Aa be made available to contractors of the United States if such
disclosure is necessary for the satisfactorv perfoi'mance of the con-
tract. Since much of the Agency's workload undoubtedly will be con-
tractual this provision is vital to the legislation's successful implemen-
tation.

EXVIROXMEXTAL PREDICTIOX AXD ASSESSMEXT

Page 43, line 17 insert after "resources to" "predict and''.

Explatmflon. The content of section 19 should reflect the intention
of the title which is to permit EPA in association with other agencies
to become involved in predicting and assessing the environmental con-
sequences of the introduction of new chemical substances into the en-
vironment.

STATE EXEMPTIOX FROM FEDERAL PREEMPTIOX

Page 45. line 14, delete subsection (b) .

Explanation. — This amendment would delete the provision that
would allow State and local governments to petition to be exempted
from Federal preemption requirements.

JUDICIAL REVIEW

Page 47, line 10: delete "not"; line 11 : insei't "not" after "are".

Explanation. — The amendment would provide that tlie Adminis-
trator's findings shall be affirmed unless not supported by the record.
Thus, the person contesting the rules must show that the record does
not support them, rather than this burden being on the Administra-
tor.

Comptroller Gexeral of the Uxited States.

Washington^ D.C.. July 11. 1975.

Hon. Harley O. Staggers,

Chairman^ Committee on Interstate and Foreign Commerce^ House
of Representatives.
Dear Mr. Chairmax' : This refers to your letter of June 3. 1975, re- j
questing our report on H.R. 7229, 94th Congress, the "Toxic Substances ,
Control Act."

In general, we observe that the objective of the legislation, which
is to regulate the use and dissemination of certain toxic chemicals,
is similar to that of the P>deral Insecticide, Fungicde and Rodenticide
Act (FIFRA), 7 U.S.C. §§ 135 et seq.. (1970) as amended by Pub. L.
No. 92-516, approved October 21, 1972. with respect to basic pesti-
cides. In this connection, we note that Pub. L. No. 94-51. approved
July 2, 1975, provides for the extension of the authorization of ap-
propriations for FIFRA until September 30, 1975. The purpose of
both FIFRA and H.R. 7229 is to protect human healtli and the en-
vironment by requiring adequate testing and other progi-ams and
procedures relatecl to specific dangerous substances. The Administra-
tor of the Environmental Protection Agency (EPA) would be re-
sponsible for execution of the provisions of H.R. 7229 and is also
responsible for administerinir FIFRA. In view of the similarity of
objectives and the responsibility of the EPA Administrator with

503

I 96

respect both to toxic chemicals and to insecticides, funo^icides and ro-
denticides, we believe it desirable that, insofar as possible, the terms
and conditions under which both laws are administered should be
uniform, particularly with respect to certain substances which, under
the respective definitions, could be controlled under the provisions of
either H.R. 7229 or FIFKA.

Therefore, with respect to the following specific provisions of
H.R. 7229, the Committee may wish to consider adopting the sub-
stance of related provisions of FIFRA :

1. In section 3(4) of H.R. 7229 the term ''commerce" is defined
in terms of interstate commerce. Thus only toxic substances involved
in interstate commerce would be covered, unlike pesticides, which are
regulated under FIFRA if disseminated in intrastate commerce as
well. We believe effectiveness of administration of both the toxic
cliemicals control law and FIFRA would be enhanced if this term
is uniformly applied under both laws. Thus, we suggest the defini-
tion of commerce in H.R. 7229 be revised to conform with the con-
cept of intrastate regulation found in FIFRA ])y amending subpara-
graph (B) of section 3(4) to read "within a State." and adding a
new subparagraph (C) to read ''which allects trade, trafhc, transporta-
tion, or exchange described in sub})aragraplis (A) and (1^) of this
paragraph." See 7 I^S.C. § l^Gj, Pub. L. No. 92-r)l(>, section 12. S.
Rep. No. 970, 92nd Cong.. 2n(l Sess. 40 (1972) on H.R. 10729.

2. Section 11 of H.R. 7229 provides for inspections of records and
properties of persons engaged in manufacturing, processing, and dis-
tributing chemical substances controlled under the j)ioposed law by
the Administrator of the EPA or his designee. AA'e believe it would
be advisable, in the interest of uniformity, to auiend section 11 to con-
form with the inspection procedui'es and authorities provided in 7
U.S.C. j< 13()g with respect to pesticides.

3. Subsection 17 (c) of H.R. 7229 provides for seizure of substances
manufactured or distributed in violation of the pioposed law. Again,
in the interest of uniformity in administi-aton of two similar and
related statutes, we suggest amendment of the seizure provision of
H.R. 7229 to conform with the stop sale, use, removal and seizure
provisions of 7 U.S.C. g 136k, Pub. L. No. 92-516, section 13.

Section 9(b)(1) of the bill provides that the Administrator of
EPA would have no authority to act under sections 6 and 7 of the
proposed Act to prevent or reduce an unreasonable risk to health or the
environment if : (A) the entirety of tlie risk involved is designed to be
protected against by another I'ederal law not administered in whole
01' in })art by the Administratoi- : or (B) if the Administrator deter-
mines that the entirety of the risk could be sufficiently prevented or
reduced by action taken undei" such other Federal law.

In the interest of clarity, we believe section 9(b)(1) should be
amended to sj^ecify which other protective laws are meant. We suggest
lanouage alonir the lines of the following as a substitute for section
9(b)(1):

''(b) (1) The Administrator shall have no authority under sections
6 and 7 of this Act to take action to prevent or reduce an unreasonable
risk to health oi- the enviromnent associated with a particular chemi-
cal substance or article containing such substance if such risk to health

504

or the environment could be prevented or reduced to a sufficient extent
by actions taken mider any other Fedei-al law; inchidino^ the Atomic
Energy Act of 1954, the Clean Air Act, the Federal Water Pollution
Conti-ol Act, the Federal Hazardous Substances Act, the Occupational
Safety and Health Act of 1970, the Consumer Product Safety Act, sub-
part 8 of part F of title III of the Public Health Service Act (relating
to electronic product radiation), 42 U.S.C. § 262 ef seq.. Pub. L. No.
90-602, October 18, 1968, and the Acts administered by the Secretary
of Transportation relating to the transportation of hazardous
substances.''.

This was the language included in a similar provision of H.R. 5356,
93d Congress, as passed by the House of Representatives July 23,
1973, and provides a specific statement of the legislative authorities to
be considei ed by the Administrator in determining whether action will
be taken under an act such as that pro]K)sed by H.R. 7229 or another
applicable statute.

Sections 10(a) and 10(b) (3) of the bill Avould authorize the Admin-
istrator of the Environmental Protection Agency to make contracts
and gi-ants for research and monitoring as necessary to carry out the
])urpose of tliis Act and for development of a data retrieval system
suitable for cai'rying out the i)urposes of the Act. In order that this
Office may have access to records connected with such contracts and
giants, and to facilitate our audit of them, we recommend that the
following new section be incorporated in H.R. 7229 :

"Sec. (a) Each recipient of Federal assistance unde^ th^s Act, pui*-
suant to gi'ants, subgrants, conti-acts, subcontracts, loans or other
arrangements, entered into other than by formal advertising, and
Avhich are otherwise authorized by this Act. shall keep such records
as the Administrator shall pi'escribe, includiiig records which fully
disclose tlw amount and disposition by such recipient of the proceeds
of such assistance, the total cost of the project or undertaking in con-
nection with which such assistance is gii^en or used, the amount of
that portion of the cost of the })roject oi- undertaking supplied by
othei- soui'ces, and such other I'ecords as will facilitate an effective
audit.

"(b) The Administrator and the Compti'ollei- General of the United
States, or any of their duly authorized I'epresentatives, shall, until the
expiration of three years after completion of the pi'oject or undertak-
ing referred to in subsection (a) of this section, have access for the
purpose of audit and examination to any books, documents, papers,
and ivcoi'ds of sucli recipients which in the opinion of the Adminis-
tratoi' or the Com])trollei" General may be i-elated or pertinent to the
grants, subgi-ants, conti'acts, subconti acts, loans or other arrangements
i-eferred to in subsection (a)."

Section 25 of the bill would requii'e our Office to make a study of
all Fedei-al laws administered by EPA for the purpose of determining
whethei- and under Avhat conditions, if any. indemnification should be
accoi'ded any person as a lesult of any action taken by the Administra-
tor under any law administered by the Agency. The study, which
would be required to be completed "no less than 2 years from the date
of enactment * * would include an estimate of the probable costs
of any indemnification programs recommended and an examination of

505.

all viable means of financing the cost of any recommended indemni-
fication.

The proposed study would require intimate knowledge not only of
all the laws administered by EPA but also of the manner in which
such laws have been administered. Such a study would be a large and
costly undertaking for our Office that might necessitate the diversion
of some of our limited manpower resources from other important
work. EPA already has most of the knowledge required for such a
study and should be able to make it at substantially less cost than our
Office. We recommend, therefore, that the Committee consider re-
quiring EPA to make the proposed study. If desired, our Office could
review EPA's study and provide a report on its adequacy either to
the Committee or to the Congress.

It should also be noted that there is a provision under FIFRA (sec-
tion 15, Pub. L. Xo. 92-516), 7 U.S.C. § i;^>6m, which authorizes EPA
to indemnify pesticide manufacturers who suffer losses by reason of
suspension or cancellation of their pesticide registrations. EPA'S
Deputy Administrator for Pesticide Programs told us that EPA was
opposed to enactment of this provision into FIFKA and that he had
supported the deletion of this provision from FIFRA in testimony
before the House Committee on Agriculture on June 20' 11)75, in the
course of oversight hearings on the Federal Environmental Pesticide
Control Act, Pub. L. No. 92-516, October 21, 1972, 7 U.S.C. §§ 186
et s('(j. (1970), Supp. III. He also stated that no payments had been
made under the indemnity provision by I^PA since it was enacted on
Octo})er 21, 1972. The EPA position favoring repeal of the indemnity
provision was also stated by the Assistant Admniistrator, Water and
Hazardous Materials at a hearing of the Subconnnittee on the Envi-
ronment, Senate Committee on (^ommerce on May 5, 1975.

Section 26(c) of the bill would require that copies of any budget
requests, legislative reconunendations, and othei- materials submitted
to the President or to the Office of Management and Budget (0MB)
in connection with carrying out the provisions of H.R. 7229 be sub-
mitted concurrently to the Congress.

It is not at all clear that the agency budget submissions, as such,
would be helpful to the Congress. Agency budget submissions to 0MB
are subject to an intensive hearing process, field investigations, and
frequently, resubmissions. In some cases where agency programs in-
volve similar or related programs of. other agencies, there is need for
elimination of duplicative requests and for adjustment of the level
of programs to assure effective interagency collaboration.
The Committee niay wish to consider, as an alternative, making
I arrangements for the advance delivery of ap])roved agency budget
, requests prior to the formal submission of the President's Budget. Ar-
[ rangements along these lines have Iwen made in the past with the
I appropriations committees in order to enable these committees to
undertake hearings at an earlier date. In some cases, it has been pos-
sible to release agency budget justifications as early as the first week
' of December.

In this connection, we note that a similar provision was enacted as
section 27 (k) of the Consumer Product Safety Act, Public Law
92-573, approved October 27, 1972, 15 U.S.C. § 2076 (k). In the light
of experience it now appears that this provision platces an agency ad-

79-313 O - 77 - 33

506

9i9

ministrator in a very difficult position due to the conflict between a
congressional mandate to supply information to the Congress concur-
rently with submissions to the Office of Manao-ement and Budget and
the provisions of 31 U.S.C. § 15 as interpreted by 0MB in its Circu-
lar A-10 which require agencies to (1) prepare budgets within guide-
lines (funding and personnel) provided by 0MB ; (2) submit budget
requests to the Congress through 0MB; and (3) defend budgets pre-
pared under 0MB guidelines in its congressional appropriations
hearings. The problems raised by this conflict were discussed in some
detail by the Chairman of the Consumer Product Safety Commission
at an oversight hearing of the Consumer Subcommittee of the Senate
Committee on Commerce on February 27, 1975. The Chairman sum-
marized his views on the question by stating that "the conflict between
section 27 (k) and the OMB's interpretation of the Chairman's duties
as a member of the executive branch raises some very serious questions
which need resolution."

VCe rec'oniineiul against enactment of tlie proposed provision in sec-
tion 26(c) of H.R. 7229 pending resolution of the conflicts discussed
by the Chairman of the Consumer Products Safety Commission to
Avhich reference is made above.

There is no provision in H.R. 7229 that EPA submit an annual re-
port to the Congress describing its activities under the Act during the
previous fiscal vear. We suggest that such a provision be included in
the bill.

In this regard, consideration should also be given to requiring that
the annual report include an evaluation of EPA's effectiveness in
carrying out its responsibilities under the Act. It is our view that
program evaluation is a fundamental part of effective program ad-
niinistration and the responsibility for evaluations should rest ini-
tially upon the responsible agencies. In line with this concept, we be-
lieve the Congress should attempt to specify the kinds of information
and tests which will enable it to better assess how well programs are
working and whether alternative approaches may offer greater
promise.

Sincerely yours,

Paul G. Dembltng
(For the Corn pf roller General

of the TJ rated States).

The Gexeral Cot^nsel of the Treasury,

Washington.. August 2U 1975.

Hon. Harley O. Staggers,

Chairman. Committee on Interstate and Foreign Commerce^ House of
Representatives^Washington.D.C .
Dear Mr. Ciiatrmax: Reference is made to your request foi- the
views of this De])artment on H.R. 7229, the ''Toxic Subst^mces Control
Act."

The })il] would establish various standards, rules and procedures
under which the Administrator of the Environmental Protection
Agency would control or restrict the use or distribution of certain
chemical substances, in order to protect health and the environment.

507

100

Section 13 of the proposed bill relates to the enforcement responsi-
bility of the Secretary of the Treasury with regard to imports of
chemical substances covered by the Act into the customs territory of
the United States. The Department recommends that section 13 be
amended as follows (language to be added is italic; language to be
deleted is bracketed) :

"Sec. 13(a) ... If a chemical substance or article is refused entry,
hereunder, the Secretary of the Treasury shall refuse [delivery] re-
lease to the consignee and shall cause the disposal or storage of any
substance or article refused [delivery] release which has not been
exported by the consignee within [three months] 90 days from the
date of receipt of notice of such refusal under such regulations as the
Secretary of the TreasuiT may prescribe, except that the Secretary of
the Treasury may [deliver] release to the consignee such substance or
article pending examination and decision hy the Administrator in the
matter on execution of a bond for the amount of the full invoice value
of such substance or article as set forth in the Customs entry
[together with] plus the estimated duty thereon, and providing for
I'fahiUty for assessment of liquidated damages equal to the full amount
of such hond hy the consignee on [refusal] failure to return such sub-
stance or article [for any cause] to the custody of the Secretary of
the Treasury-, when demanded, for the purpose of excluding them
from the country or for any other purpose [such consignee shall for-
feit the full amount of such bond]. All charges for storage, cartage,
and labor on substances or articles which are refused admission or
[delivery] release under this section shall be paid by the owner or
consignee, and in default of such payment shall constitute a lien
against any future entry into the United States made by such owner
or consignee."

The Department has no independent knowledge of the need for the
bill and no comments on its general merits. It is believed that enact-
ment of the proposed legislation would increase Customs workload
to some extent, although no unusual administrative difficulties are
anticipated.

The De])artment has been advised by the Office of Management and
Budget that there is no objection from the standpoint of the Adminis-
tration's program to the submission of this report to your Committee.
Sincerely yours,

Donald L. E. Ritger,
Acting General Cou/nsel.

Committee Amendment

508

SUPPLEMENTAL VIEWS BY CONGRESSMAN
JOHN D. DINGELL

I believe that it is necessary to put a specific requirement into H.R.
14032 to ensure that EPA will take prompt measures to deal with
PCB's. Unfortunately, one of the bill's shortcomings is its failure to
mandate action on hazardous chemicals in a timely fashion. There
is no specific directive for the Administrator to take action to control
the most hazardous chemicals within a certain period of time. All of
the Agency's actions are discretionary, and subject to the viscissitudes
of political pressures and budget starvation. From what we can see of
EPA's past record, we cannot be particularly sanguine about the
Agency's ability to act quickly.

With this knowledge, brought on by retrosj^ective studies on PCB's,
it is clear that steps to control production, use, and disposal are needed,
to protect the health and well-being of human and other life forms. If
Japan, as the largest producer of electronic equipment, can replace
PCB's with some other, more neutral component, then the U.S. can
follow suit. The Toxic Substances Control Act would be considerably
strengthened by providing a means to control PClVs. During the Com-
mittee consideration of H.R. 14032. I offered an amendment — which
was rejected — to prescribe methods for manufacture, use, and disposal,
and eventually phase-out of PCB's. This amendment is sorely needed
to prevent further contamination, death and future PCB incidents.

The problems associated with widespread use and dispersal of
PCB's (Poly chlorinated Biphenyls) are a prime example of the type
of chemical hazard to which the Toxic Substances Control Act should
immediately address itself. PCB's like their chemically similar cohort
DDT, are extremely stable (long-lived) which leads to the risk of bio-
accumulation and concentration in fish and other aquatic animals as
well as in the tissues of man. The dangers involved for man include
numbness and pain in the extremities, reduced sensitivity to pain
and/or heat, slowed nervous reactions, acne-like skin eruption, tempo-
rary failure of eyesight, sense of weakness and cancer of the liver.

In 1968, in Yusho, Japan, PCB's leached into rice oil used for cook-
ing and affected 1,000 people in varying degrees depending upon ex-
posure levels. The intake of 0.5-2 grams by those contaminated resulted
in a wide variety of illnesses, particularly affecting the skin, eyes, and
nervous system. The children bom of pregnant women who ingested
the contaminated oil were also affected with skin disorders and were
smaller in size. Although direct proof was lacking, PCB contamina-
tion was also suspected as, at least, a co-factor in some deaths and still
births.

Percentages of PCB's found in the blood of Americans, both urban
and rural dwellers, have been found to equal those of the Yusho inci-
dent. Disruption of the normal function of the liver from PCB's at
those low^ levels (0.5-2 grams) causes the skin disease named after the

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victims at Yusho. Besides Yusho disease, low exposures can cause
metabolic disturbances, embryo abnormalities, abortions and miscar-
riages. Laboratory experiments document this knowledge. The distri-
bution of PCB is ubiquitous. Xow banned for most uses in Japan,
PCB's still remain in the environment from past uses such as food con-
tainer cardboards and wrappings, boat paints, fireproofing, and textile
coatings.

PCB contamination of waterways is of equal severity throughout
the United States, and especially in the Great Lakes area and the
Northeast. Commercial fishing in Lake Michigan ceased in 1971 due
to pollution from PCB's. and recently it has been feared that all com-
mercial fishing on the Great Lakes — a $95 million annual industry —
could be sliut down because of PCB contamination. In addition, it has
been warned that PCB's could cause the imminent collapse of the $350
million-a-year sportsfishing tourist industry in the Upper Great Lakes.
Early this year the Hudson River was closed as a commercial fishery-
for most species of fish (particularly striped bass) due to high levels
of PCB's which exceed Federal standards. It has been estimated that
22 million pounds of Hudson River striped bass are consumed each
year from both commercial and sport catches.

Air is the major agent of transport for PCB's followed by water.
The leaching and vaporizing of PCB's from materials and dump sites
release from 1-2 thousand tons of the contaminant a year. Industrial
spills have led the FDA to advise the public not to eat the fish from
the Hudson River. Lake Ontario, Lake Michigan, Pensacola Sound
and the Milwaukee and Ohio Rivers where gross contamination with
PCB's has been measured. One hundred gallons of PCB's can contami-
nate 10 trillion gallons of ILO.

My amendment was improperly criticized for singling out one spe-
cific chemical for action when no other hazardous chemicals were
specified for action in the bill. It is entirely proper for Congress to set
priorities for action in any piece of legislation and PCB's have proven
themselves dreadfully toxic and extremely persistent. Because of this,
it is incumbent upon Congress to direct EPA to take prompt action
on PCB's. I urge my colleagues to support my amendment on the
Floor of the Hoilse during consideration of this measure.

John D. Dingell.

510

SUPPLEMENTAL VIEWS OF MESSRS. MOSS, DINGELL,
METCALFE, BRODHEAD, MOFFETT, AND MAGUIRE TO
H.R. 14032, THE TOXIC SUBSTANCES CONTROL ACT OF
1976

In the most routine and necessary activities, the American public
is exposed to thousands of untested chemical substances each day. The
growing body of evidence indicating some of these chemicals for their
damage to human health and the environment leads us to support
sti ong toxic substances control legislation.

H.R. 10432 contains a number of provisions which we expect will
be effective in providing this protection, and we are grateful for the
efforts of those Avho crafted this compromise bill and successful shep-
herded it through the full committee consideration. However, we be-
lieve the compromise falls short in several key areas. The following
provisions need to be strengthened in order to provide adequate pro-
tection for public health.

SECTION 4(E). ACTION BY THE ADMINISTRATOR ON ADVISORY COMMITTEE

PRIORITY LIST

Section 4(e) of H.R. 10318, the bill reported by the Subcommittee
on Consumer Protection and Finance, established an interagency ad-
visory committee to make recommendations to EPA of chemicals
which should be tested. A list of chemicals, ranked in priority for
action, was to be periodically submitted to EPA, and th« complete
list was to be published in the Federal Register. Within 12 months
of receiving the list the Administrator was required to either promul-
gate a rule requiring testing or to publish in the Federal Register the
reasons for not taking action. H.R. 14032 changed the provision in
two important respects: (1) The requirement that the list be published
in the Federal Register was replaced by a requirement that the Admin-
istrator merely make the list available to the public; and (2) the
requirement that the Administrator act on the recommendations within
12 months or publish reasons for not doing so was also deleted.

Removal of the data certain within w^hich the Administrator must
act or explain why he or she is not acting undermines the likelihood
that the agency will deal expeditiously on the interagency advisory
committee recommendations for testing of key toxic chemicals. Pub-
lication of agency decisions to act or not act pursuant to the authori-
ties granted by this bill is also an important oversight tool for Con-
gress and the public to determine whether the agency is properly
carrying out its mission. If a chemical is important enough to be
listed, it is important enough for the Administrator to consider action
on it, either affirmatively or negatively, within one year of being
listed.

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136

SECTIOX 5. IXADEQUATE PREMARKET TESTING AUTHORITY

Section 5 of H.R. 10318 required that a manfactiirer give the En-
vironmental Protection Agency 90-day premarket notification of
intent to begin commercial production. The Administrator was to
review the notice and determine whether or not it contained sufficient
safety information. In cases where safety information was insufficient
and testing would provide that information, the Administrator was
authorized to promulgate regulations to halt manufacture until ade-
quate safety information could be developed. Under the subcommittee
bill, such regulations could be made inunediately effective.

H.R. 14032 changed section 5 to remove this authority to act after
receiving notification. The substitute instead requires the Administra-
tor to petition the U.S. district court to enjoin manufacture of the
chemical or its distribution in commerce before the Administrator can
proceed with a rulemaking under section 5(g) to impose manufactur-
ing limitations or prohibitions.

Requiring EPA to petition the courts to prohibit marketing of a
chemical about which there is inadequate safety information, rather
than allowing the agency to require proper testing prior to marketing,
places an unnecessary burden upon the courts and the agency. Fur-
thermore, it places within the courts the decisionmaking which prop-
erly belongs to the Administrator.

SECTION 5. EXPLANATION BY THE ADMINISTRATOR OF WHY HE OR SHE IS
TAKING ACTION OR NOT TAKING ACTION

At the expiration of the premarket notification period the Admin-
istrator has the option of initiating regulatory action or allowing the
chemical to be marketed with no further action, or in some cases re-
quiring further testing. At this point, the Administrator should give
the public an explanation of what he or she has decided to do and why.
The frequent complaint that Government agencies are impenetrable
bureaucracies is due in part to the absence of provisions such as this
which would require an explanation to the public and the Congress
about a decision not to act under the discretionary provisions of the
bill. It has an additional benefit in that the explanation would enhance
congressional and public oversight of the Agency's decisionmaking
criteria and framework.

SECTION 6. DELEGATION OF THE AUTHORITY TO ISSUE AN IMMEDIATELY

EFFECTIVE RULE

The committee bill inappropriately deleted section 6(d) in H.R.
10318 which permitted the Administrator to declare a proposed ac-
tion prohibiting manufacture, processing or distribution of a chemical
substance or mixture to be immediately effective when such a substance
poses an unreasonable risk. Such a procedure is essential to protect the
public health and environment during the pendency of administrative
decisionmaking. By contrast, H.R. 14032 would allow the public and
the environment to be exposed to potentially lethal chemicals during
agency deliberations which include hearings and limited cross-exami-
nation of witnesses. The bottomline is that lives, not short-term profits,

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137

are at risk during whatever time is required for EPA to act under the
procedures established by H.R. 14032. This is a dramatic concession of
the public interest to private, commercial concern.

Authority for expedited agency action is grounded in the Adminis-
trative Procedure Act, which the courts have routinely held gives an
agency needed discretion to act quickly. The deleted section was more
cautious than the APA required in that it mandated that the agency
provide an opportunity for oral presentations expeditiously after the
Administrator has acted.

A common theme in recent calls for regulatory reform is complaint
about cumbersome procedures. The change in this section removes the
Administrator's authority to move quickly when circumstances re-
(juire.

SECTIOX 6. CUMBERSOME FINDINGS WILL DELAY PROMPT AND EFFECTIVE

ACTION

Section 6(c) of H.R. 14032 requires the Administrator to determine
whether the risk could be eliminated by taking action under another
Federal law administered by the Administrator. If such is the case, the
Administrator must make a complicated finding that it was in the
public interest to regulate under section 6(a) rather than the other law.
The finding has to take into consideration all aspects of the risk, as
well as make comparisons between this law and the other laws of the
costs of complying, and of the "relative efficiency of actions.'^The pro-
cedure established by the committee bill appears likely to delay effec-
tive action by the Administrator because it imposes unnecessary and
time-consuming requirements for findings as to the relative efficiency
of the proceeding under this act or another statute.

SECTION 18. PREEMPTION OF STATE REGULATIONS

Section 18(a) of H.R. 10318 allowed States to ban use of chemical
substances independent of any EPA action. H.R. 14032 in section 18(b)
denies States the authority to regulate a risk associated with a par-
ticular chemical if the Federal Government has already acted with
respect to that risk. A limited exemption to ths preemptive policy is
allowed if EPA determines, after substantial review, to allow a State
to act to protect its citizens.

Traditionally States have been most sensitive to the health concerns
of their citizens. As a consequence. States have been granted wide lati-
tude under the Commerce clause of the Constitution to act on behalf of
their citizens even when those regulated are marketing their products
through the channels of interstate commerce. Congress has also enacted
legislation which liberally defines the role of the States in important
health and safety laws (Clear Air Act, 52 U.S.C. Section 1857(d);
Federal Water Pollution Control Act, 42 U.S.C. section 1376).

Unfortunately, H.R. 14032 imposes on States a substaniial barrier
to action to protect their citizens when EPA has taken limited steps to
regulate a particular chemical. They must apply to the Administrator
for approval of their actions. This clearance can be granted only after
detailed inquiries by the Administrator, inquiries which will be di-
rected to the States with their attendant costs. Finally, both the action

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of the State and the action of the Administrator would be reviewable
in court. Such procedural roadblocks protect manufacturers but do
little to protect the public.

ADDITIONAL RECOMMENDATIONS

Lack of enforcement schedule

One serious inadequacy in the Toxic Substances Control Act is the
lack of any time-phased enforcement requirements. We can look for
models to the air and water pollution control statutes currently in ef-
fect. If this legislation does not have careful deadlines for EPA action,
the likely result will be prolonged delay and repeated postponements.

EPA should be recpiired to publish criteria for identifying those
substances for which regulations would be required, within six months.
One year after publication of the criteria the Agency should be re-
quired to publish a list of all existing substajices which should be regu-
lated and to divide the list into three groups relative to the need for
timely action. EPA should then issue regulations for the highest prior-
ity group within 2 years, the second group within 3 years, and the third
group within 4 years. The Administrator should be required to make
an annual review and revision of the lists. Under such a plan EPA
would be required to issue regulations for all chemicals which were
found to be posing an unreasonable risk to health or the environment
within 71/2 years after enactment of the legislation.

It is essential for the protection of public health and the environ-
ment that the legislation seek to give the EPA a firm mandate for a
comprehensive approach to protection from hazards due to chemical
substances. Such will only be achieved through legislative directives
and adequate financial support. As it stands now, the bill gives the
EPA an imprecise directive and inadequate funding. In light of mul-
tiple hazards the public and the environment face, the lack of a pre-
cise mandated for prompt and comprehensive action renders this
legislation inadequate.

Subpoena power

The committee bill does not provide the agency with subpoena power
for such purposes as gathering information for investigating violations
of the act, for deciding whether to take regulatory action, or for ana-
lyzing information in the agency's possession. It is inconceivable the
agency can operate properly without the authority to demand infor-
mation under traditional appropriate safeguards.

John E. Moss.

John D. Dingel.

Ralph H. Metcalfe.

William M. Brodhead.

Toby Moffett.

Andrew Maguike.

514

MINORITY VIEWS ON H.R. 14032 TOXIC SUBSTANCES

CONTROL

The bill, H.R. 14032, which was reported by the Committee on
Interstate and Foreign Commerce on June 9, would give the Admin-
istrator of the Environmental Protection Agency broad new powers
over this country's chemical industry. In its barest form, the bill
authorizes the EPA to require that manufacturers perform tests pre-
scribed by the Agency, and give the Agency advance notification of
its intent to market new chemicals or existing chemicals for new uses.
Further, EPA is authorized to issue mles regulating the manufac-
turing, processing, use or disposal of a chemical as well as require
that the company maintain records and submit reports as required by
the EPA.

The House has passed Toxic Substances legislation in both the 92d
and 93d Congresses, but this bill goes far beyond anything we have
ever voted on. We are especially disappointed that the committee
abandoned the approach adopted in the 93d Congress with respect
to premarket notification and screening (section 5). In earlier bills,
the Administrator of EPA was authorized to compile a list of those
chemicals which he finds pose a danger to health or the environment
and the manufacturer of a listed chemical must then provide EPA
with notice prior to marketing. In this manner the Administrator's
attention would be focused on those potentially dangerous chemicals.
The bill reported by the committee, on the other hand, would require
that manu,facturers of all new chemicals and new uses of existing
chemicals notify and supply EPA with specified information 90
days prior to manufacture or marketing. EPA could extend that
period another 90 days. This approach is objectionable because EPA
will have to draw upon already limited staff and resources to give
each reported substance or use thorough scrutiny within the time
allotted. Further, we fear that EPA will be able to hold up the manu-
facturing of a chemical for up to 6 months for no better reason than ,
administrative backlog.

We fear that this legislation will prove ruinous for the small com- ;
panies which make up much of this country's chemical industry. |
Industry estimates put the cost of this legislation at between $358
million and $1.3 billion annually. Even the General Accounting,
Office estimated an annual cost of as much as $200 million. Further, it ,
can cost as much as $800,000 to test a single chemical. Although we i
hope that EPA would not be so unreasonable as to routinely require
testing of this magnitude, the costs of testing could be considerable, i
and the costs of testing will fall heaviest on smaller. companies. i

Further, in the more than 100 pages making up this legislation,
there is set out an incredibly complicated regulatory maze which is ,
guaranteed to completely baffle any layman attempting to pick his '

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140

way through it. And the bill Avill be augmented by more rules and
regulations issued by the EPA. As we add these increased layers of
bureaucracy, it Avill become more and more difficult to develop and
process new chemical compounds. This will not present a great prob-
lem to the large chemical companies with their vast legal staffs. But
for the small company, the time and expense of fighting the bureau-
cratic machine, as well as the significant costs of testing, may serve to
discourage him from undertaking the project at all. This is especially
true when he is not able to predict the market a particular chemical
may have.

We fear that the end result of this bill will be a long-range and
insidious effect on inventiveness and innovation in the American
chemical industry. Faced with extensive testing, the burden of pre-
market screening, and the rigors of regulation under this bill, devel-
opment and innovation in the chemical industry will inevitably be
curtailed.

Although the above observations are of a general nature, we are
specifically concerned about sections 20, 21, 23, and 24, and recommend
that they be deleted from the legislation. We do not believe that these
provisions do anything to improve the legislation but, in fact, could
be used to harass companies regulated by EPA.

Section 20 provides that any person may bring a civil action against
a company regulated under this act or against the EPA in order to
enforce the act. Further, the bill specifies that complete costs of the
suit, plus attorneys' and expert witnesses' fees, will be paid. If any
individual has any idea about suing, he will find an eager lawyer who
will bring this case to the already overcrowded judicial docket.

Section 21 provides that any person may petition EPA to issue a
rule requiring testing or regulating of a substance. If EPA denies the
petition and if the petitioner can show, by a preponderance of the
evidence in a de novo proceeding in U.S. district court, that the sub-
stance may cause or contribute to an unreasonable risk, the court must
order EPA to begin the requested proceeding. The citizen petition
provision, with its requirement for a trial de novo, will force the Fed-
eral courts to hear complex, scientific testimony and make technical
decisions more appropriately left to an expert regulatory agency. In
essence, the court will be called upon to second-guess the judgment of
the EPA in areas in which it has no expertise. Requiring that courts
consider and decide technical and scientific factual questions rather
than questions of law, not only places an undue burden on the Federal
courts but also destroys the purpose for creating EPA as an expert
agency. Further, this provision substantially diminishes the agency's
ability to determine its priorities and channel its resources.

Section 23 is entitled "Employee Protection" and would prohibit
an employer from disciplining an employee because that employee
may have or is about to issue a complaint with the EPA. Of course,
this means that any time there is an incompetent employee who has
been put on notice that he is doing a poor job, one can anticipate that
he will commence a proceeding against the company. He will, thereby,
have the Secretary of Labor and the Administrator of the EPA pro-
tecting him until the case is disposed of — possibly years in the future.

This section, along with section 24, which authorizes EPA to con-

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duct investigations, issue subpoenas and hold hearings to determine
the effects on employment from threatened plant closing which might
be brought about by this act, provide so much potential for harass-
ment that we strenuously object to their inclusion in any final legisla-
tion.

Finally, we note that Section 14(e) of the bill provides that in-
formation reported or obtained by the Administrator under this bill
shall be made available upon written request of any duly authorized
Committee of Congress. We firmly believe that such a provision is
needed in that both courts and Attorneys General of the United

gress of "trade secret" infonnation which was statutorily obtained by
agencies of the United States Government would be a breach of con-
fidentiality. A clear example of this position is enunciated in the case
of Hearst v. Bla^k. 87 F. 2d 68 (D.C. 1936). In this case, the Federal
Communications Commission was enjoined from turning over to a
Senate Committee certain material which the agency was statutorily
required to treat as confidential. In the Hearst case there was no pro-
vision similar to section 14(e) ; if there had been Hearst would have
had no case. Our position then is that Congress does have the power
to acquire information of this sort, but not without the benefit of
legislation that specifies that Congress can acquire it. The question of
inherent authority is a matter for the courts to determine.

This provision in the bill raises an equally important question which
the committee chose not to address. That question is: What is Con-
gress' obligation to keep "trade secret" material confidential? This
bill recognizes that there is certain information that should be kept
confidential by the Executive Branch, but then Congress grants itself
access to this information with no restrictions on disclosure. We be-
lieve that if Congress grants itself access to this type of material then
Congress should establish the internal mechanisms that would insure
that "trade secrets" be kept confidential. Bear in mind that Congress
is continually requiring the business community to turn over highly
valuable and sometimes sensitive material to Federal agencies, and the
business community is complying. They are complying because they
understand that their trade secret and proprietary data will not be
disclosed. If it becomes painfully apparent to the business community
that these valuable materials will not be safeguarded, we believe that
this climate of cooperation will seriously deteriorate.

States have traditionally taken

Samuel L. Devine.
James M. Collin.

HOUSE CONSIDERATION OF H.R. 14032

[Excerpt from the Congressional Record, Aug. 23, 1976, House, pp. H8803-SS63]

Toxic Substances Control Act

Mr. Pepper. ^Mr. Speaker, by direction of the Committee on
Rules, I call up House Resolution 1458 and ask for its immediate
consideration.

The Clerk re^d the resolution, as follows :

H. Res. 1458

Resolved, That upon the adoption of this resolution it shall be in order to
move that the House resolve itself into the Committee of the Whole House on
the state of the Union for the consideration of the bill (H.R. 14032) to reflate
commerce and protect health and the environment by requiring? testing? and neces-
sary restrictions on certain chemical substances and mixtures, and for other
purposes. After jjeneral debate, which shall be confined to the bill and shall con-
tinue not to exceed one hour, to be equally divided and controlled by the chair-
man and ranking? minority member of the Committee on Interstate and Forei^
Commerce, the bill shall be read for amendment under the five-minute rule. It
shall be in order to consider the amendment in the nature of a substitute recom-
mended by the Committee on Interstate and Foreigm Commerce now printed in
the bill as an original bill for the purpose of amendment under the five-minute
rule and said substitute shall be read for amendment l>y titles instead of by
sections. At the conclusion of such consideration, the Committee shall rise and
report the bill to the Hou.se with such amendment*? as may have been adopted,
and any Member may demand a separate vote in the House on any amendment
adopted in the Committee of the Whole to the bill or to the committee amend-
ment in the nature of a substitute. The previous question shall be considered as
ordered on the bill and amendments thereto to final passage without intervening
motion except one motion to recommit with or without in.«;tructions. After the
passage of H.R. 14032, it shall be in order to proceed to the consideration of the
bill S. 3149, section 402 of the Congressional Budget Act of 1074 (Public Law
93-344) to the contrary notwithstanding, and it shall be in order in the House to
move to strike out all after the enacting clause of said Senate bill and insert
in lieu thereof the provisions of H.R. 14032 as passed by the House.

Mr. Pepper. Mv. Speaker, House Resolution 1458 provides for the
consideration of H.R. 14082. Toxic Substances Control Act, granting
to the Administrator of the Environmental Protection A^enc}^ regu-
latory' authority to protect public health and the environment from
potentially harmful chemical substances.

The resolution would permit the House to consider the legislation
under an open rule with 1 hour of general debate. The rule makes the
amendment in the nature of a substitute recommended by the Com-
mittee on Interstate and Foreign Commerce now printed in the bill
in order as an original bill for the purpose of amendment.

The rule also makes it in order to call up the bill S. 3149 for the
purpose of substituting the House-passed language, and waives points
of order which could be raised under section 402 of the Congressional
Budget Act— Public Law 93-844.

Se<?tion 402 prohibits consideration of authorization bills for fiscal
year 1977 unless they were reported by May 15, 1976. This bill, S. 8149,

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518

was reported before May 15 in the Senate and thus was not in viola-
tion of the Budofet Act when considered by that body.

H.R. 14032 does not contain authorizations for fiscal year 1977. The
Senate bill does and when it is called up in the House it could be sub-
ject to a poiut of order. However, we are calling up the Senate bill
solely for the purpose of insertino^ the House-passed language and,
therefore, the waiver does not violate the spirit of the Budget Act.
This assurance was given to the Committee on Rulers by the Budget
Committee which has no objection to the waiver.

Mr. Speaker, there are more than 30,000 chemicals on the market
and only a few thousand have been adequately tested to determine if
they are safe. This number grows by about 1,000 each year, and there
is no requirement that these chemicals be evaluated for health and
environmental effects before they are marketed. Moreover, there is
inadequate authority to regulate a chemical once it is discovered to
be hazardous.

Toxic substances control legislation was ])assed in the House and
the Senate in both the 92d and 93d Congresses, but time did not per-
mit the conferees to resolve the differences between the House and Sen-
ate passed bills. This year, I understand the legislation passed by the
Senate and that reported by the House Commerce Committee are
much more similar.

H.R. 14032 has the general support of the major industry trade
groups, enA'ironmental groups, citizens, and labor. I urge adoption
of House Resolution 1458 so that we may proceed to the consideration
of the Toxic Substances Control Act.

Mr. Dei. Claw^sox. Mr. Speaker, as my colleague from Florida has
explained House Resolution 1458 provides for the consideration of
H.R. 14032, the Toxic Substances Control Act — a bill designed to
regulate commerce and protect health and the environment by requir-
ing testing of and restrictions on certain chemical substances and
mixtures, and for other purposes. The resolution furnishes an open
rule with 1 hour of general debate.

Upon the adoption of the resolution, it will be in order to consider
the amendment in the nature of a substitute recommended by the Com-
mittee on Interstate and Foreign Commerce now printed in the bill
as an original bill for the purpose of amendment.

The substitute shall be read for amendment by titles instead of by
sections. Subsequent to the passage of H.R. 14032, it will be in order
to proceed to the consideration of the bill S. 3149, section 402 of the
Congressional Budget Act of 1974 notwithstanding, and to move to
srtrike out everything after the enacting clause of the Senate bill and
insert the provisions of H.R. 14032 in its place.

H.R. 14032 will require manufacturers and processors of potentially
harmful chemical substances and mixtures to test the substances or
mixtures as required by rules issued by the Administrator of the En-
vironmental Protection Agency so that their effect on health and the
environment may be evaluated tSec. 4].

It will require manufacturers of new chemical substances and man-
ufacturers and processors of exi&ting chemical substances for signifi-
cant new uses to notify the Administrator 90 days in advance of com-
mercial production [Sec. 5].

519

The bill will authorize delays or restrictions on the manufacture of
a new chemical substance if there is inadequat-e information to evalu-
ate the health or environmental effects of the substance and if in the
absences of such inforaiation, the substance may cause or significantly
contribute to an unreasonable risk to health or the environment
[Sec. 6].

Further, it will authorize the Administrator to adopt rules to pro-
hibit, the manufacture, processin^r. or distribution of a chemical sub-
stance or mixture, to require labeling, or to regulate the manner of
disposal of a chemical substance or mixture for which there is a rea-
sonable basis to conclude that it causes or significantlv contributes to
an unreasonable risk to health or environment [Sec. 6^.

These provisions, and there are many more, are certainly compre-
hensive, but I wonder if, in our haste to deal with the onerous prob-
lems of toxic substances, if we are not paying too little attention to
the ramifications of the legislation as it relates to the American chemi-
cal industry. In the more than 100 pages of this legislation, an incredi-
bly complicated regulatory maze is mandated which is guaranteed
to completely stymie any layman's attempt to wade through it. And
the bill will be augmented bv additional rules and regulations issued
by the EPA.

As each layer of thick bureaucratic tape is applied over the hands
and tools of American chemical companies, it will become more and
more difficult to develop and procCvSs new chemical compounds, espe-
cially for the smaller companies involved. For them it will virtually
be an impossible task. The larger chemical companies who have the
means to retain vast legal staffs will, of course, be presented with only
a minor problem.

But what of the small chemical companies i What are we forcing on
these companies who are struggling to compete on the market ^ Mr.
Speaker, is it really responsible for us to seek to solve one major prob-
lem at the risk of creating another of similar magnitude i

The House. Mr. Speaker, has passed toxic substances legislation
previously — in both the 92d and 93d Congresses. Xever before has
this House made provision to place such a hea\'y burden on our com-
petitive market where small chemical companies are concerned.

I would ask my colleagues to thoughtfully consider the conse-
quences of the adoption of this legislation and to decide for themselves
whether or not the burden is too heavy.

Mr. Speaker, in order that we may move to answer these (luestions
and debate the provisions of the bill, I ask that the resolution be
adopted.

Mr. Pepper. Mr. Speaker, I move the previous question on the
resolution.

The previous question was ordered.

The resolution was agreed to.

A motion to reconsider was laid on the table.

Mr. Murphy of New York. Mr. Speaker, I move that the House
resolve itself into the Committee of the Whole House on the State of
the Union for the consideration of the bill (H.R. 14032) to regulate
commerce and protect health and the environment by requiring test-
ing and necessary restrictions on certain chemical substances and mix-
tures, and for other purposes.

520

The Speaker. The question is on the motion offered by the gentle-
man from New York (Mr. Murphy).
The motion was agreed to.

IN THE COMMITTEE OF THE WHOLE

Accordingly the House resolved itself into the Committee of the
"Whole House on the State of the Union for the consideration of the
bill H.R. 14032, with Mr. Mann in the chair.

The Clerk read the title of the bill.

By unanimous consent, the first reading of the bill was dispensed
with.

Mr. McCoLLiSTER. Mr. Chairman, H.R. 14032, the Toxic Substances
Control Act, is designed to give the Administrator of the Environ-
mental Protection Agency broad, new authorities to regulate the
chemical industry. That this legislation is before us today in its pres-
ent form is a mark of the fine work done by the gentleman from Texas
and the gentleman from North Carolina who were successful in work-
ing out many of the problems which have surrounded this bill. On two
previous occasions, this body has passed similar legislation only to
have the bills die in conference. I will admit that the bill leaves unad-
dressed some of the issues voiced by both sides to the controversy sur-
rounding this bill, that is the environmentalists and the affected
industries. Indeed, as I will discuss in a moment, I still have questions
about several provisions. But, on a whole, I believe that the legislation
presents a fairly well-balanced regulatory scheme which, if imple-
mented in a reasonable fashion, will not prove to be unduly burden-
some on those regulated. Therefore. I hope that we can pass this legis-
lation and send it on to the White House in its present form.

In general, the bill would give EPA the authority to promulgate
testing standards for chemical substances and mixtures, require a 90-
day premarket notification period for all new^ chemical substances,
and presribe various regulations whicli the chemical industry would
have to meet. I want to take a moment to discuss the premarket
notification provision of the legislation [Sec. 5], since this provision
has been one of the most controversial sections of the bill. The bill
would require manufacturers of all new chemical substanecs to notify
EPA and provide certain specified information at least 90 days prior
to manufacture or marketing. This approach of requirinof premarket
notification for all new substances represents, in my view, quite a
departure from previous House-passed bills which would have limited
])remarket scrutiny to substances which EPA found posed a danger
to health or the environment. I believe that the more limited approach
found in earlier House bills would serve to better focus EPA's atten-
tion and limited resources on the potentially dangerous chemicals, and
I regret that we have decided to reject this more limited approach
Avhich the House did adopt in both the 92d and 93d Congresses.

Section 5 is probablv one of the most onerous provisions of the
legislation with its requirement for premarket notification of all new
chemical substances. However, this section does contain exemptions.
For example, chemicals which are manufactured in small quantities
for sale to laboratories foi- research purposes would not be subject to

521

the premarket notification provisions of the bill. Further, research
and analysis being performed during the developmental stages of
chemicals which may ultimatley be produced commercially would also
be exempt from the premarket notification provisions of the bill. This
exception for research and analysis related^ to product development
would exist regardless of whether the manufacturer were evaluating
the product within its own plant or had made the product available
to a potential customer with or without the pa3'ment of a foe. Section
5 must not be interpreted in such a way as to stifle product develop-
ment and innovation, and we expect that EPA will implement Section
5 and the other provisions of the bill so that this result will not occur.

Section 6 of the bill gives EPA the authority to promulgate rules
regulating the manufacture, processing, use and disposal of chemical
substances and mixtures. At the outset, EPA is directed to issue the
least burdensome requirement possible. For example, EPA could not
ban a substance for a particular use if a labeling requirement would
provided adequate protection. We have followed past practice in estab-
lishing a fairly formal rulemaking procedure, including opportunity
for an oral hearing, a limited right to cross-examination, and judical
review based on the substantial evidence test. Further, EPA would
be required to make certain findings before issuing a rule, including a
finding as to the economic consequences of the rule taking into account
the impact of the rule on small business.

The legislation does give the EPA authority to require that manu-
facturers maintain records and periodically submit reports. [Sec. 8]
However, we also recognize that such recordkeeping can be unduly
burdensome. Consequently, the legislation directs the agency to require
the maintenance of reports that are nonduplicative of those required
by other Federal Government agencies. Further, the legislation con-
tains a partial exemption for small businesses from the recordkeeping
requirement.

Even though, as a whole, I believe that H.R. 14032 is a well-honed
piece of legislation, it does contain what I believe to be a very trouble-
some provision in section 21 dealing with citizens' petitions. This
section would allow a private citizen to petition the YjPA to promul-
gate a rule requiring testing or the regulation of a particular chemical
substance. Should EPA deny the petition or not act on the petition,
the citizen could go to Federal court and, if he could show in a de novo
proceeding that the substance could possibly pose a risk, then the
court would direct the agency to initiate the rulemaking proceeding
as requested by the petitioner. A provision such as this was first in-
serted in the Consumer Product Safety Act and became effective in
late October of 1975, with respect to the Consumer Product Safety
Commission. This provision was inserted in the Product Safety Act
as an experiment, and I believe that it is too soon to determine what
effect, if any, the citizens' petition provision will have, not only on
the workload of the agencies, but also on the caseload of the Federal
courts. I believe that we should resist the temptation to insert this
provision in other legislation until we have more closely examined the
experience of the Consumer Product Safety Commission over a par
ticular period of time.

79-313 O - 77 - 34

522

Further, I think it is inappropriate to insert this pro^dsion piece-
meal into different bills. It may be that a citizens' petition provision
is indeed a desirable concept and, if so, it should be made applicable
to all regulatory agencies. If not, the concept should be dropped once
and for all. To insert it in A'arious bills in such a crazy-quilt fashion
makes little sense, and I regret that the provision has found its way
into the bill before us today.

Finally, I want to say a few words about the impact which this
bill could have on small businesses. Certainly all Federal legislation
falls more harshly on small businesses than on large companies who,
as a rule, are better able to hire the legion of attorneys and accountants
needed to cope with the myriad rules and regulations that some agen-
cies hand down. However, we have, in this bill, made a genuine effort
to deal with some of the unique problems that small businesses face.
Further, we expect that EPA in implementing this bill, will pay spe-
cial attention to the particular needs of small businesses. For example,
in section 27 of the bill, we give EPA the authority to collect filing
fees of up to $2,500 to defray the cost of administering the act. How-
ever, these fees are to be based on ability to pay and we expect that
EPA would impost lower fees, if any at all, on small companies.

Finally, we expect that EPA will establish close contact with the
Small Business Administration so that EPA can more adequately
inform itself as to the particular problems faced by the small business
community. Franldy, I have found that the small business community
has little confidence in EPA's ability to issue sensible rules and regula-
tions. This lack of confidence is based on EPA's past track record. If
EPA will counsel with the Small Business Administration, to deter-
mine what effect its regulations will have on small companies, then
this act need not have the harsh consequences that some are presently
predicting. I, for one, will be closely watching EPA's performance in
this regard.

Mr. Chairman, I think it probably should be said also that on both
sides in the committee there was an effort made to hold to the language
of the bill. I know that the conversations between the gentleman from
N'orth Carolina (Mr. Broyhill) and the gentleman from Texas
(Mr. Eckhardt) will indeed be tested here and there, and some of the
amendments offered may well seem to be very attractive. But I think
we are obligated — we who have worked out the compromise — to hold
to the language of the bill. I should have much preferred that the bill
which I introduced originally would be the vehicle before us today. I
regret that it is not. In am^* case, H.R. 14032 is the product of that
labor before the Committee of the Whole today, and I hope that it
passes in its present form.

I think that the distinguislied gentleman in the well has underesti-
mated his influence with respect to this bill in his very generous state-
ment concerning myself and the gentleman from Xorth Carolina
(Mr. Broyhill). Actually he has, I think, devised many of the provi-
sions that afford protection to small business. Perhaps we have not
adopted enough to totally suit him. I suspect that that is true. Because
he has been such a stalwart defender of the interests of independent
small businesses on our committee, it might be difficult for us ever
totally to suit him on that matter. But I think great credit must be
given to the gentleman in this regard.

523

There is one thing that I would like to bring out in this colloquy.
The gentleman from Nebraska had referred to the premarket notifi-
cation section of the bill [Sec. 5] and indeed that is perhaps the most
controversial portion. He did mention cetraiii exemptions and per-
haps one other thing needs pointing out. This is on page 163 with
respect to the administrative authority in identifying a chemical sub-
stance. It states ;

[Sec. 8(b)] (2) To the extent consistent witli the purposes of this Act
the Administrator may, in lieu of listing, pursuant to paragraph (1), a chem-
ical substance individually, list a category- of chemical substances in which such
substance is included.

I may say to the gentleman, I tliink tliis is an extremely important
leeway to the Administrator. Say for instance a chemical substance
is manufactured and produced inliouse in an oil and chemical refinery.
That chemical substance may be a catalyst that undergoes successive
changes. Under these provisions we felt that instead of requiring a 90-
day notice every time a change was made that had the result of chang-
ing the chemical constituency of the substance, the single category
conmient.

I think that the gentleman will agree with me this is one of of the
provisions in which we carefully examined difficulties which could
result from too rigid an act and met those possible objections.

Mr. McCoLLisTER. I do agree and I am grateful for the gentleman's
could be mentioned and changes could be made within that category.

Mr. McGuiRE. Mr. Chairman, I rise in support of this landmark
legislation. Everyone will agree that in considering legislation to pro-
tect the environment Congress must achieve a sensible balance between
the needs of the economy and the need to protect the public health and
welfare. Xo one will advocate shutting down the economy in order to
protect the environment. And no one will advocate destroying the en-
vironment in order to protect the economy. Too often, however, the de-
only satisfy one heed or the other need, but not both. I strongly dis-
agree. I believe that both needs can, should, and must be met. The
fact is that society cannot live long without either. This is not to imply
that satisfying lx)th needs is an easy task. It requires difficult deci-
sions. It also requires a strong desire to work for and to achieve mod-
erate resolutions of competing interests.

Faced with this task of resolving the conflicting needs of the econ-
omy and the environment I undertook to bring a measure a balance
to the Toxic Substances Control Act. The concerns expressed by the
chemical companies in New Jersey as well as those of the citizens and
workers of my State, who daily face living in environment which
continues to deteriorate, had to bo weighed and i-econciled.

My efforts in the full Commerce Committee markup of this bill were
aimed at developing new approaches which sought to alleviate the
costs of compliance to chemic^il manufacturers and processors, espe-
cially those small and medium size companies to whom the additional
costs of regulation might prove prohibitive without some kind of
relief.

I sponsored three amendments to the bill in committee which were
designed to approach this needed balance. All were approved. My first
amendment, which redefines "mixtures'' to include a broader range
of fonnulations than did H.K. 10818, was incorporated in the drafting
of the compromise bill, H.R. 14032 [Sec. 3(8)], which we are now

524

considering. By redefining the mixture definition, to include certain
kinds of reactive mixtures, it now more accurately difi'erentiates be-
tween those mixtures to which the premarket notification requirements
of section 5 would apply and tliose mixtures for which premarket
notification would not be necessary. This has the efi'ect of eliminating
what would have been unnecessary regulation for a special class of
mixture products which are generally produced by smaller chemical
companies.

Two other amendments which I developed were unanimously ap-
]n-oved in committee action.

The first [Sec. 26(d)] requires the Environmental Protection
Agency — EPA — to establish an identifiable office to provide technical,
referral and other nonfinancial assistance to chemical manufacturers
and processors. In the accompanying report language it is clearly
stated that this office shall concentrate its efforts on reaching oui to the
small and medium size chemical companies who will benefit in a great
way from such an office. Details as to the status of standing regula-
tions, outstanding public comment ])eriods, legal assistance made avail-
able for cei-tain provisions of the bilL shared-cost testing arrange-
ments, and so foilli, will all be available to companies through this
office. Another important function of the office would l)e to refer
com]:>anies to the ]:)roper authorities in the regular Office of Toxic
Substances who can handle specific problems. This concept of an iden-
tifiable office to assist small businesses may lead the way toward
chancres in other regulatory agencies where small businesses seem to
l)e given less than adequate attention when regulations are proposed
and implemented.

My final amendment addressed the question of which t/jsts. from
among available test methods, might be ordered by the Administrator
under section 4 authority. Recent developments in the field of toxi-
cological testing have centered on the emergence of low-cost, short-
term bacteriological and mammalian cell te^ts for mutaofenicity. These
tests show great ]:)otential for cutting down on the cost to all com-
panies of testing their products to show what degree of hazard, if
any, may be Dosed by their ]:>roducts. These test methods are in need
of further i-efinements and the National Cancer Tnstiute is conducting
a research Di'0<xram into this area. Mv amendment authorizes the Sec-
retary of Health, Education, and Welfare, in consultation Avith the
EPiA Administrator and acting through the Assistant Secretary for
Health, to conduct and make grants and contracts for continued
research into the field of low-cost and efficient test methodologies
[Sec. 271.

Since the committee considered this bill the HEW appropriation for
fiscal year 1077 ha> been announced and it directs that $3 million be
included in the budget for the National Institute for Environmental
Health Sciences to expand its programs for short-term testing research
and the carcinoirenesis bioassay program being conducted in collabora-
tion with the National Cancer Institute. It appears from correspond-
ence which I have conducted with the Assistant Secretai-y for Health
that added funds will not be needed at this time. Even so, the Assistant
Secietary^ in his response to my inquiry on current testing programs,
assured me that my amendment, in the context of this new reo^ulatorv
bill, stands as an important statement of national policy that such

525

test methods shall be considered, wherever feasible, for use in place of
whole animal tests. The presence of grant and contract authority may
yet prove significant for the purposes of this legislation. I am
presenting the text of this letter for inclusion in the Record :

Department of Health, Education, and Welfare,

Washington, D.C., August 19, 1916.

Hon. Andrew Maguire,
House of Representatives,
Washington, B.C.

Dear Mr. Maguire : Thank you for your letter of July 27 concerning the current
status of research in the development and validation of short-term toxicity tests
in the Department of Health, Education, and Welfare laboratories. We share
your view that establishing the reliability of rapid bioassay tests is very likely
to have far-reaching impact on future regulatory decisions.

In addition to a wide variety of ongoing research activities in this area, the
Department is presently developing a document on methods for determining
mutagenic proi^erties of chemicals which addresses the current utility of short-
term tests for the identification of mutagens in the environment. This activity is
under the direction of the Department's Committee to Coordinate Toxicology and
Related Programs, chaired by the Director of the National Institute of Environ-
mental Health Sciences (NIEHS).

As indicated by your letter, within the Department the NIEHS and the
National Cancer Institute (NCI) are conducting and supporting most of the
research and development in this area. These Institutes, beginning in the mid-to-
late 1960's. pioneered in the development of short-term tests as a means of rapidly
identifying chemicals having potential to cause either cancer or genetic defects.
Since 1974 there has been considerable expansion of both Institutes' programs
in this area utilizing grants, contracts, and, of course, intramural research to
develop and evaluate inexpensive and efficient methods for assessing the health
and environmental effects of chemicals.

As you may know, the Committee on Appropriations for the Department of
Labor and the Department of Health. Education, and Welfare in its Report on
the FY 1977 Appropriation directed that an additional $3 million be included in
the budget for NIEHS to expand short-term testing and for collaborative activi-
ties with NCI concerning the carcinogenesis bioassay program. As pointed out
in that report, a very close working relationship exists between these two Insti-
tutes for developing short-term tests and establishing their acceptability as
prescreens and possible alternatives to studies re(iuiring years to conduct.

There are ongoing, continuous program activities at both NCI and NIEHS
which seek to establish a matrix of procedures which can serve as an effective
prescreen, and to establish priorities for further in-depth testing.

In our view the Public Health Service Act currently contains ample authority
for our current and projected activities in this area. We would have no objection
to additional language being included in the Toxic Substances Act as a statement
of National ix)licy.

In any event we agree with you that this is a vitally important area to the
future health of the American i^eople and we will continue to stress our efforts
in this area.

Sincerely yours,

Theodore Cooper, M.D.,
Assistant Secretary for Health.

With the Toxic Substances Control Act now beintr considered by
the full House I will be proposint; a further amendment to give the
Administrator of EPA the authority to make grants to selected States,
with severe problems related to toxic chemicals, like Xew Jersey, to
covei' up to 75 percent of tlie costs of establishing and operating pro-
grams to prevent or eliminate unreasonable risks in the States to
health or the environment associated with chemical substances or mix-
tures. The grant money is earmarked for use in ways which will com-
plement the activities already underway or being planned by EPA for
the implementation of this act and for activities which the Admin-

526

istrator is unable to undertake because of inadequate resources or other
higher priorities. It is not intended to, and will not replace, EPA's
authority to require reporting, testing or any other of the authorities
given in this act.

The need for strong provisions to begin i-eversing the deterioration
of public health caused by toxic substances which is so evident in my
own State of New Jersey is clear. The same is true of other States —
New York, Pennsylvania, Ohio, and Texas, for example.

There can be no doubt that the chemical industry has brought great
benefits to the people of this country through continuing advances in
the manufacturing, agricultural, and service sectors of the economy.
But we have paid a. high price for that progress. For far too long the
chemical industry has proceeded to conduct business without giving
adequate attention to the health and environmental dangers of the
substances which they produce. At last we have before us legislation
which will take significant steps toward insuring that the industry
assumes full responsibility in protecting the public from those chemi-
cal products which are hazardous.

As a representative from the State of New Jersey I am all too
familiar with the serious health problems in my State and the relation-
ship of these problems to the heavy concentration of industrial activity
there. New Jersey is host to nearly one-fourth of the chemical com-
panies in this country. Evidence mounts that some of this chemical
manufacturing and processing activity may pose a genuine threat to
the public health. The major study on cancer mortality by counties,
conducted b}^ the National Cancer Institute, found a high correlation
between cancer deaths and densely concentrated industry. New Jersej^'s
21 counties were found to be in the top 10 percent of all counties in
the Nation for the rate of cancer deaths. In Salem County, N.J., where
25 percent of the male population works in the chemical industry, the
Nation's highest rate of bladder cancer deaths was recorded. This
alarming rate of bladder cancer mortality, an occupational disease
associated with exposure to various chemical substances, emphasizes
the suspected relationship of chemicals in the workplace and the en-
vironment and the excessive cancer incidence and mortality in our
State.

On May 28 of this year I chaired an official hearing in Newark, N.J.,
of the Commerce (committee's Oversight and Investigations Subcom-
mittee. The subject of the hearing was "Cancer in the Environment"
and the testimony of experts pointed to the fact that indeed the chemi-
cal population in New Jersey is extensive and that EPA does not yet
know what chemical, toxic pollutents are present in our State. As a
result of that hearing EPA granted a request from the commissioner
of the New Jersey Department of Environmental Protection to con-
duct air monitoring, especially for nitrosamines known to be carcino-
genic to humans. Not only were nitrosamines found in the atmosphere
in our State but they were also present in significant concentrations
in our soil and water along with significant amounts of other organic
chemicals. Monitoring to establish the quantities of chemical sub-
stances must be continued and expanded ; especially multimedia moni-
toring which would give a comprehensive evaluation of the passage
of chemical substances from one medium to another. It is to problems
such as exist in New Jersey, and for State programs such as this, which
would augment EPA efforts, that the funds from another amendment

527

I will be offering would apply. I will discuss the particulars of that
amendment when I offer it later today.

In conclusion, let me stress that New Jersey is actively working to
evaluate the extent of these serious threats to the public health. Gov.
Brendan Byrne has established a cabinet committee on cancer in an
effort to coordinate Xew Jersey's programs at the highest level of
government. The department of environmental protection in our State,
an agency whose programs have earned the respect of EPA, is
presently drawing u]) plans to expand its programs for measuring the
extent of exposure to and the presence of carcinogens, and other en-
vironmental contaminants, in the environment.

Specifically the department would like to undertake an inventory of
toxic chemicals in use in the State which would record their amounts,
forms, and sources of emission, and their ultimate pathw^ays through
the environment. Ilaving identified types of substances and pinpointed
the serious risks, monitoi'ing programs would be refined to go beyond
measuring the overall pollution of various media and take in more
detailed information on organic and inorganic materials, concentra-
tions of which may not be evident f i-om general sampling techniques.
Additionally much remains to be learned about the safe handling and
disposal of itoxic wastes and the department of environmental protec-
tion is j)resently drawing up plans to study and develop safer methods
of disposal.

I enclose for the Record, a recent article "The War on Cancer", by
Glenn Paulson and Peter W. Preuss of the New Jersey State Depart-
ment of Environmental Protection.

[From the New York Times, Aug. 15, 1976]
War on Cancer: The Deadly Fight
(By Glenn Paulson and Peter W. Preuss)

The Cancer Atlas^ published in 1975 by the National Cancer Institute, showed
that for a large number of different cancers the State of New Jersey as a whole
and many counties within the state ranked significantly above the national
average over the 20-year period from 1950 to 1970.

Cancer rates vary significantly between regions in the United States. In
general, states with high rates are the Industrial states, such as New Jersey.

We cannot precisely estimate, for New Jersey or for the nation, the extent to
which observed cancer rates and changes in those rates are caused by chemicals.
Some cancer undoubtedly arises from natural sources, such as cosmic or solar
radiation ; our best judgment is that this is a small fraction.

However, there ate many examples of cancer directly traceable to industrial
or other human activities that involve chemical or other cancer-producing agents.

Liver cancer caused by vinyl chloride, mesothelioma caused by asbestos fibers,
lung cancer caused by arsenic compounds, uranium dust, and other agents, a
particularly debilitating lung cancer caused by beryllium, and bladder cancer
caused by dye and chemical intermediates such as beta-naphthylamine are a few
of the well-understood examples. Unfortunately, even the primitive knowledge
available at this time leads us to conclude that more such examples will be found
in future yeai-s.

Exposure or carcinogenic materials is not confined to the industrial work place.
In a preliminary assessment of drinking water carried out by the United States
Environmental Protection Agency, known and suspected carcinogens (cancer-
causing agents) were found in the two New Jersey sources of drinking water
that were tested, the Passaic Valley Water Commission and Toms River Water
Company. The significance of the levels that were found is not clear, however.
This was a preliminary assessment ; E.P.A. made no attempt to measure other
families of known or suspected carcinogenic agents.

528

The Department of Environmental Protection should devote more effort to
determining and defining the dangers New Jersey residents face as a result
of exposure to carcinogens and other environmental contaminants. One impor-
tant step would be to begin to inventory the presence and patterns of use of
toxic chemicals in tlie environment. Another need is to expand eflorts in measur-
ing the concentrations of carcinogenic and other exotic pollutants that mav be
present in the air, drinking water supplies, fish and otJier wildlife, surface 'and
ground waters, and sediments.

At present, the department has permit systems that collect data on the emis-
sions of certain relatively common pollutants into the air and water. These
existing systems should be expanded to provide information on the emissions
of all potentially carcinogenic and other toxic substances. The Solid Waste
Administration is developing an equivalent system that would allow it to collect
information at a level of detail similar to that obtainable through the air and
water permit systems ; this system will allow collection of data regarding
emissions, treatment and disposal of solid and liquid toxic wastes.

A department- wide inventory would provide information about the toxic
chemicals currently in use in New Jersey, their amounts, and their emissions,
as well as their ultimate pathways into the environment. This information will
allow priorities to be established for monitoring and regulation. It will also
help establish the criteria upon which regulations may be based, including,
for example, toxicity, persistence in the environment, and amounts used in the
state.

To avoid creating more problems in the future, a program should be estab-
lished for the environmentally safe treatment and disposal of solid wastes.
Such a program would logically be a part of the overall solid waste management
program being developed by the Solid Waste Administration. One of the first
steps is to determine what kind of wastes are produced, how they are trans-
ported, and where they are treated and disposed.

There are a number of toxic substances for which sufficient information is
available now, so that a determination may be made as to the unsuitability of
their disposal on land. In order for these wastes to be disposed of properly,
however, alternative treatment or disposal methods must be made available.
This will require the development of criteria to define environmentally sound
disposal procedures.

The first priority in this area is the development of performance criteria for
incinerators that are or may be used to dispose of toxic and liazardous organic
materials. These criteria must insure that the materials are burned completely,
and that no toxic substances enter the air through the stack or into the water
via water used for cleaning ("scrubbing") the exhaust gases.

The presence of one or more such facilities in New Jersey would provide a
necessary alternative to help insure that environmentally dangerous chemicals
may be safely treated.

Another problem is the disposal of sludge produced in sewage-treatment
facilities. Sludge often contains toxic substances from the effluents of industrial
facilities that feed into the sewage plant ; sludge is presently disposed of in the
ocean. Tlie Federal policy for disposal of such sludges calls for the phasing out
of ocean dumping by 1981 ; as a result, alternative methods will have to be found.

It will be necessary to monitor carefully the development of alternative pro-
grams, as well as the facilities themselves to insure that toxic substances pres-
ent in sludge are not inadvertently released into the environment.

The Department of Environmental Protection, by building on its existing
legal authorities and regulatory programs, can take sound steps toward mini-
mizing the threat that cancer-causing agents and other toxic and hazardous
pollutants pose to human health in New Jersey.

Mr. Otting?:r. Mr. Chairman, T would like to conofratulate the sub-
committee cliairman and the gentleman from Nebraska for brin^n^
this vitally important le^rislation before us, this le<rislation which is
vitally important to the health of the Nation, and particularly to
complement, as thev did. the jjentleman from Texas (Mr. Eckhardt)
and the .o;entleman from North Carolina (^Ir. Broyhill) for the adept
manner in which they were able to work out with the chemical indus-
try the very complicated, complex, economically sio^iificant, and con-
troversial items in this bill. I think they did a superlative job and ^ot

529

a meaningful bill through the committee which obtained the support
of the chemical industry. I think that is an attribute to both their
efforts and the chemical industry.

The February 13, 1976 issue of Science Magazine had an article
titled "Control of Toxic Substances : an idea whose time has nearly
come." I dearly hope the time is now, for this legislation has been
stalled for too long as the cancer rates of the country continue to soar.
AMien medical authorities seem to agree that between 60 and 90 per-
cent of all cancers have an environmental cause, surely the place to
test new chemicals for their potential hazard is not after they have
reached the environment, but in the laboratory.

The Toxic Substances bill, H.R. 14032, is not a perfect panacea
for the frightening statistics mentioned above but it is a most impor-
tant beginning and I commend my colleagues on the Interstate and
Foreign Commerce Committee who have worked so hard to bring this
legislation forward.

The issues dealt with in the legislation are of overwhelming impor-
tance; we are sadly more and more aware of the significance as we
read of horrendous instances of either chemical pollution or of
''mysterious fatal diseases" — all of which might have been prevented
if legislation such as this had been in operation sooner. I want also
to congratulate both the environmental and consumer groups who
have worked together in support of the bill before us.

While I very strongly support the bill, I believe it needs to be
improved with respect to the use of nonanimal tests where they are
adequate and accurate.

TOXIC SUBSTANCES BILL

At the appropriate time, I will offer an amendment to H.R. 14032,
the Toxic Substances Control Act, to prevent the unnecessary use of
animals in laboratory experiments.

My amendment to section 4(2) (A) states that "* * * in prescribing
tests the Administrator in his discretion shall give preference to
available tests which do not involve the use of animals if such tests
provide an adequate and accurate means for ascertaining the effect of
a chemical substance or mixture on humans and the environment."

This amendment does not ban the use of animal tests, nor does it
make it more difficult for the Administrator to prescribe animal tests
if he feels they are" necessary. Quite simply, it is meant to require the
Administrator to consider alternative testing methods and direct him
to use them when, in his discretion, he finds they are adequate and
accurate.

Two nonanimal tests presently exist, and have been used to test the
toxic effects of known and unknown carcinogens. One such test uses
bacteria ; the other laboratory-grown mammal cells. Both are cheaper,
easier, faster, and as effective as their whole animal counterparts. I
think we should promote their use where feasible and thus minimize
the pain and suffering administered to laboratory animals.

I strongly support adoption of the bill and hope this improving
amendment will be adopted.

^ Mr. Collins of Texas. Mr. Chairman, we have heard much discus-
sion about the compromises that were reached between the two sides.

530

I could not help but think as I kept sitting there and listening, I wish
we would compromise all the facts so we did not have any bill at all.
The people that advocated these compromises represented big com-
panies, because big industries can send a lawyer down here. They can
send technicians down here to express the views of big industry ; but
Avhat we are faced with is the fact that the little businessman, who
runs a small Business with 40 or 50 people in it, does not have 10
people in his legal section. He does not have specialized chemists that
can fight this thing. So what happens when we pass a bill of this typo
is that there is no way a small businessman can live under it. The
bureaucracy, the paperwork, the complications, make it overbearing
on the manager of small business. The least, I think, that anyone could
process for approval would be about $50,000. That will be the least
cost and he cannot put up that much or maybe $100,000. He cannot
afford that sort of thing. So it is going to be the end of the line for
all but the giants. i

Mr. Chairman, I would like to further discuss some of the other
features of this bill. One group that is probably going to be hurt thei
most of all is agriculture. We have in this country the greatest agri-
cultural system that has ever been developed. I come from a city. I del
not have over 20 farmers in my district, but the thing that always
impressed me was that the American farmers make up only about
4 percent of our population; yet we produce more food than any-
body. We really do produce. Over in China, I think it is 80 percent
of the people woi'k on farms. In order to produce, they need chemicals
and they need these materials to help them.

Mr. EcKHARDT. Mr. Chairman, is the gentleman under the impres-
sion that this bill would do anything at all with respect t^ pesticides?

Mr. Collins of Texas. I just think in general that anything could
be involved through lawsuits. I understand pesticides are out; but
we could say anything is a chemical. How do we define "a chemical"?
I thought any combination of elements became a chemical.

Mr. EcKiiARDT. Mr. Chairman, if the gentleman Avill yield further,
that is right; but there are exceptions in the bill. The principal thing
this bill purports to do is require that those chemicals put on the
market be reported and tested ; but Ave have absolutely nothing in the
bill that preA'ents them from flowing to the marketplace after a maxi-
nnim of 180 days, unless court action has been taken and that court
action has to be based on a determination that they pose a danger.

NoAv, how is the farmer affected by this bill ? I cannot see it.

Mr. Collins of Texas. Well, it has been my experience Avith the
courts that as they reach out on their interpretation of any and every
subject, that they can go a long way to determine Avhat is terminology.
When they determine something to be a pesticide or not is whatevei
the court determines it to be.

T can giA^e an example, not on this bill, but on busing. There is
nothing on the books that says Congress has permitted busing, but
courts OA^er the country are defining busing to meet their vicAvs. When {
AA'e raise the question that there is nothing here that says pesticides, T
Avould remind my friend, the gentleman from Texas, that the lawyers,
the judges on the benches, Avill read into this anything they want to.

When we set up the mechanism for EPA to develop it, then Ave have
set up the toxic subject for full bureaucratic intervention.

531

We have so many bureaucratic rules now that EPA can get into
anything they choose. What disturbed me especially in this bill was
the fact that we have two sections in here that are going to make it
possible for any employee who sees that he is about to be fired to take
some action that should give him permanent employment. I am refer-
ring to sections 23 and 24. It not only protects him, but it seems that
it would almost encourage lawyers to represent him.

Section 23 says:

No employer may discharge any employee or otherwise discriminate against
any employee with respect to the employee's compensation, terms, conditions, or
privileges of employment because the employee (or any person acting pursuant
to a request of the employee) has —

(1) commenced, caused to be commenced, or is about to commence or
cause to be commenced a proceeding under this Act ;

(2) testified or is about to testify in any such proceeding; or

(3) assisted or participated or is about to assist or participate in any
manner in such a proceeding or in any other action to carry out the pur-
poses of this Act.

Whait that will do, for instance, is to have this complaint go to the
Secretary of Labor. Anybody who is a deadhead on the job, lazy,
comes in drunk, tears up the whole place, can now file some kind of
complaint on the grounds that something is wrong with the company's
products, and from then on he has got built-in job protection. To carry
that a step further, when they get through the company has to rein-
state the complainant to his former condition as far as compensation
goes, and also may include compensatory damages and exemplary
damages.

I want to go to section 24, because we seem to be encouraging labor
unrest in this bill. In section 24, they say :

The Administrator shall evaluate on a continuing basis the potential effects
on employment (including reductions in employment or loss of employment
from threatened plant closures) of —

(1) the issuance of a rule or order under section 4, 5, or 6, or

(2) a requirement of section 5.

(b) (1) Investigations. — Any employee (or any representative of an em-
ployee) may request the Administrator to make an investigation of —

(A) a discharge or layoff or threatened discharge or layoff of the em-
ployee, or

(B) adverse or threatened adverse effects on the employee's employment,
allegedly resulting from a rule or order under section 4, 5, or 6 or a require-
ment of section 5. Any such request shall be made in writing, shall set forth
with reasonable particularity the grounds for the request, and shall be signed
by the employee, or representative of such employee, making the request.

We have a provision in this bill and in the terminology, of the re-
port as written up to provide for any interested civic group to enter
into this intervention action. The lawyer of this civic group is paid
by the court on a full fee scale above his regular salary level. It seems
to encourage these foundations and civic groups to have their salaried
people enter into legal proceedings, because they are going to draw
even more in compensation.

If I ever saw a mumbo-jumbo bill encouraging an employee to do
a bad job for a company, this it it. It encourages lawyers, if they are
not fully occupied, to stir up one of these lawsuits under this bill.

We have passed more laws in this session of Congress than in any
session of the Congress. Yet, when we go home to talk to the folks back
home, they will tell us that this is a poor Congress. The reason is that

532

we are passing more bills than the public needs, more than it wants,
and certainly more than it can afford. The only ones I can see who are
going to benefit from this particular piece of legislation are lawyers.

At this time I would like to include the minority views that were
filed with this bill where I was joined by my colleague, the gentleman
from Ohio (Mr. Devine).

Mr. Chairman, the bill, H.R. 14032, which was reported by the
Committee on Interstate and Foreign Commerce on June 9, would
give the Administrator of the Environmental Protection Agency
broad new powers over this country's chemical industry. In its barest
form, the bill authorizes the EPA to require that manufacturers per-
form tests prescribed by the Agency, and give the Agency advance
notification of its intent to market new chemicals or existing chemicals
for new uses. Further, EPA is authorized to issue rules regulating the
manufacturing processing, use or disposal of a chemical as well as re-
quire that the company maintain records and submit reports as re-
quired by the EPA.

The House has passed toxic substances legislation in both the 92d
and 93d Congresses, but this bill goes far beyond anything Ave have
ever voted on. We are especially disappointed that the committee
abandoned the approach adopted in the 93d Congress with respect to
premarket notification and screening — section 5. In earlier bills, the
Administrator of EPA was authorized to compile a list of those chem-
icals which he finds pose a danger to health or the environment and
the manufacturer of a listed chemical must then provide EPA with
notice prior to marketing. In this manner the Administrator's atten-
tion would be focused on those potentially dangerous chemicals. The
bill reported by the committee, on the other hand, would I'equire that
manufacturers of all new chemicals and new uses of existing chemicals
notify and supply EPA with specified information 90 days prior to
manufacture or marketing. EPA could extend that period another 90
days. This approach is objectionable because EPA will have to draw
upon already limited staff and resources to give each reported substance
or use thorough scrutiny within the time allotted. Further, we fear
that EPA will be able to hold up the manufacturing of a chemical for
up to 6 months for no better reason than administrative backlog.

We fear that this legislation will prove ruinous for the small com-
panies which make up much of this country's chemical industry. In-
dustry estimates put the cost of this legislation at between $358 million
and $1.3 billion annually. Even the General Accounting Office esti-
mated an annual cost of as much as $200 million. Further, it can cost
as much as $800,000 to test a single chemical. Although we hope that
EPA would not be so unreasonable as to routinely require testing of
this magnitude, the costs of testing could be considerable, and the costs
of testing will fall heaviest on smaller companies.

Further, in the more than 100 pages making up this legislation,
there is set out an incredibly complicated regulatory maze which is
guaranteed to completely baffle any layman attempting to pick his way
through it. And the bill will be augmented by more rules and regula-
tions issued by the EPA. As we add these increased layers of bureauc-
racy, it will become more and more difficult to develop and process new
chemical compounds. This will not present a great problem to the large
chemical companies with their vast legal staffs. But for the small

533

company, the time and expense of fighting the bureaucratic machine,
as well as the significant costs of testing, may serve to discourage him
from undertaking the project at all. This is especially true when he is
not able to predict the market a particular chemical may have.

We fear that the end result of this bill will be a long-range and
insidious effect on inventiveness and innovation in the American
chemical industry. Faced with extensive testing, the burden of pre-
! market screening, and the rigors of I'egulation under this bill, devel-
I opment and innovation in the chemical industry will inevitably be
' curtailed.

Although the above observations are of a general nature, we are
il specifically concerned about sections 20, 21, 23, and 24, and recom-
I mend that they be deleted from the legislation. We do not believe
that these provisions do anything to improve the legislation but, in
: fact, could be used to harass companies i-egulated by P]PA.

Section 20 provides that any person may bring a civil action against
a company regulated under this act or against the EPA in order to
enforce the act. Fui-ther, tlie bill specifies that complete costs of the
suit, plus attorneys' and expert witnesses' fees, will be paid. If any
individual has any idea about suing, he will find an eager lawyer who
will bring this case to the already overcrowded judicial docket.

Section 21 provides that any person may petition EPA to issue a
rule re(juiring testing or regidating of a substance. If EPA denies the
petition and if the petitioner can sliow, by a preponderance of the
('N'idence in a de novo proceeding in ILS. district court, that the sub-
stance may cause or contribute to an unreasonable risk, the court must
oi'dei' EPA to begin the i'e(]uested proceeding. The citizen petition
})rovision, with its requirement for a trial de novo, will force the
; FedoT-al courts to hear complex, scientific testimony and make tech-
1 nical decisions more appropriately left to an expert regulatory agency.
; In essence, the court will l>e called upon to second-guess the judgment
of the EPA in areas in which it has no expertise. Requiring that
:; courts consider ami decide technical and scientific factual questions
I rather than questions of law, not only places an undue burden on the
Federal courts but also destroys the purpose for creating EPA as an
K expert agency. Further, this provision substantially diminishes the
' agency's ability to determine its priorities and channel its resources.
Section 23 is entitled "Employee Protection" and would prohibit an
employer from disciplining an employee because that employee may
r| have or is about to issue a complaint with the EPA. Of course, this
V means that any time there is an incompetent employee who has been
i[ put on notice that he is doing a poor job, one can anticipate that he
I will commence a proceeding against the company. He will, thereby,
j have the Secretarv of Labor and the Administrator of the EPA pro-
' tectinjr him until the case is disposed of — possibly years in the future.

This section, along Avith section 24. which authorizes EPA to
t conduct investigations, issue subpenas and hold hearings to determine
' the effects on employment from threatened plant closintr which might
be brouirht about by this act, provide so much potential for harass-
ment that we strenuously object to their inclusion in any final legisla-
tion.

Finally, we note that section li(e) of the bill provides that infor-
? mation i-eported or obtained by the Administrator under this bill
shall be marie available upon written request of any duly authorized

534

committee of Congress. We firmly believe that such a provision is
needed in that both courts and Attorne3's General of the United States
have traditionally taken the position that disclosure to Congress of
''trade secret'' infonnation which was statutorily obtained by agencies
of the U.S. Government would be a breach of confidentiality. A clear
example of this position is enunciated in the case of Hearst v. Blacky
87 F. 2d 68 (D.C. 1936). In this case, the Federal Communications
Commission was enjoined from turning over to a Senate committee
certain material which the agency was statutorily required to treat as
confidential. In the Hearst case there was no provision similar to
section 14(e) ; if there had been Hearst Avould liaA^e had no case. Our
position then is that Congress does have the power to acquire infor-
mation of this sort, but not without the benefit of legislation that
specifies that Congress can acquire it. The question of inherent author-
ity is a matter for the courts to determine.

This provision in the bill raises an equally important question which
the committee chose not to address. That question is : What is Congress
obligation to keep ''trade secret" material confidential? This bill rec-
ognizes that there is certain information that should be kept confi-
dential by the executive branch, but then Congress grants itself access
to tliis information with no restrictions on disclosure. We believe that
if Congress grants itself access to this type of material then Congress
should establish the internal mechanism that would insure that "trade
secrets'' be kept confidential. Bear in mind that Congress is continu-
ally requiring the business community to turn over highly valuable
and sometimes sensitive material to Federal agencies, and the business
community is complying. They are complying because they under-
stand that their trade secret and proprietary data will not be disclosed.
If it becomes painfully apparent to the business community that
these valuable materials will not be safeguarded, we believe that this
climate of cooperation will seriously deteriorate.

Mr. Chairman, I recommend that we vote against this bill.

Mr. Stagoers. Mr. Chairman, members of the Committee, this bill
has been considered in the 92d, 93d, and now^ the 94th Congress. The
House has passed it twice, and s*^ has the Senate. We have never been
able to come to agreement in conference.

I would be remiss if I did not say that this is not a perfect bill. I do
not know of a perfect bill that has passed this House. There are some
flaws in it, but we will try to w^ork them out in conference. This bill
should be passed.

This bill principally is intended to have new chemicals coming on
the market regularly tested to see that they are not going to harm
people or the environment.

Mr. Chairman, as I said, it is not a perfect bill. We all know that.
There are some imperfections, and there may be some amendments
made to it. T am sure that if we find some things that are wronof with it,
we can try to correct them. But this is legislation which has been
needed for a great many years.

Mr. McCorxTSTER. Mr. Chairman, I want to say that we are at the
point where we are because a great manv difficidt issues have been com-
promised and agreed upon, and T would hope we would not go further
in our conference with the Senate than we have gone here: that we
have a A ery delicate balance now, and T am iust cautioning the Mem-
bers that that balance can be destroyed rather readily.

535

Mr, Staggers. Mr. Chairman, I can agree with tlie gentleman. The
gentleman remembers that is one of the reasons the first bill did not
pass. The Senate insisted upon theirs, and we said, "We have to be
reasonable to the business people of America,'' and -sve did not com-
promise on what we thought was right for business in the land.

Mr. Chairman I Avant to compliment the gentleman from Nebraska
on his part through the years in Avorking on this legislation and for
his interest. Ke has done a great job. as well as the chairman, the
ranking member on the other side, and the gentleman from Texas
(Mr. Eckhardt). They have all been very interested in these 4 or 5
years that we have been working on this bill and they have done an
excellent job.

Mr. Hicks. ^Ir. Chairman, the action tlie Congress takes in consider-
ing the Toxic Substances Control Act is a test of our concern for the
American people. It is also a test of our consistency. My special con-
cern with this legislation stems from hearings that tlie ^lanpower and
Housing subcommittee of the Government Operations Committee held
on controlling toxic substances in the workplace. We all know that
controlling hazardous materials is import^int in the marketplace and
on the farm, but those who must handle potentially dangerous chemi-
cals every day they earn their bread are at even greater hazard. They
can neither select the chemicals to which they will be exposed, nor
avoid such exposure except at the cost of their job.

The vote on this legislation will show where we strike the balance
between imposing more requirements on those who produce and market
chemicals — a fact we must recognize — and providing protection to
many who cannot by any means provide it for themselves. I think
this balance has to be struck by placing more responsibility on those
who manufacture and formulate chemicals. A recent study by the
National Institute for Occupational Safty and Health disclosed that
almost half the exposures to identified cancer-causing chemicals was
attributable to the use of products that were identified only by trade-
names. The composition of these was treated as a secret by their form-
ulators. Our hearings showed that we are way behind in our ability
to identify chemicals that can destroy the health of workers who are
exposed to them daily. We are even further behind in developing
standards for the labeling and control of those chemicals that Ave al-
ready knoAv are hazardous. Presently, complete standards exist for
fcAA-er than 2 dozen chemicals. Even here, the fact of exposure to these
chemicals Avas unknown in close to half the cases because the ingre-
dients of the products used Avere not disclosed. Surely this is a situa-
tion that AAT can no longer tolerate.

I said that our A^ote Avill also be a test of our consistency. In 1970, we
passed the Occupational Safety and Health Act. As we all know, the
Act has been the subject of much controversy. That controA^ersy. how-
CA'er, has centered on some of the standards and the Avay they are ap-
plied; it has not swirled around the requirement in the act that an
employer tell his employees AA'henever they are exposed to a dangerous
concentration of hazardous chemicals. Since the passage of this act,
employers have had a legal requirement to inform employees about
dangerously hi^h leA^els of exposure. Such a requirement is certainly
warranted in these days when thousands of new chemical products are
flowing into the workplace eA^ery year. Yet, in our hearings this year.

536

the Assistant Secretary of Labor for Occupational Safety and Health
agreed that employers could not comply with the law because they did
not know the composition of products that the}^ use in their plants.

Look at the size of the problem — the NIOSH Registry of Toxic
Chemicals lists over 19,000 unique chemical substances. The Council
on Environmental Quality estimates that 700 new chemicals enter com-
mercial production each year. Yet, the Occupational Safety and Health
Administration has been able to issue standards at a rate of only three
per year. Both the Assistant Secretary for Occupational Safety and
Health and the Director for the Institute of Occupational Safety and
Health testified at our hearings that without a toxic substances control
act, federal regulatory machmeiy will never catch up. Unless we re-
quire testing of chemicals before they are marketed, how are we to
knoAv the toxic effects of new chemicals? Regulation after the fact
not only uses our workers as experimental groups without their con-
sent, but also fails to protect them even after damage to their co-
workers establishes that a chemical is dangerous.

It can be contended that the burden should be put on the employer —
that he should refuse to purchase products unless the manufacturer
discloses their composition. This approach is used b}- some large com-
panies today, with varying degrees of success. In our hearings, we
looked at the practices of the Federal Government — the Nation's
largest employer — to determine how successfully the Government it-
self was complying with the law that this Congress passed 6 years ago.
For the past 5 of these years, there has been a Federal standard that
required Government purchasers to obtain hazardous material data
sheets that disclosed the hazardous substances in any product. Despite
this, the large purchasing agencies of the Government have obtained
these sheets only in a few scattered instances, and Government hy-
gienists, safety professionals, and doctors in the field installations
we visited often had never received any data sheets on the hundreds
of chemicals that these installations use daily. If the Federal Govern-
ment cannot tell its employees what they are exposed to, what chance
does the owner of a small establishment have of demanding and re-
ceiving this information from suppliers who have been effectively
denying it to the Federal Government in the face of existing regu-
lations ?

Mr. Chairman, our hearings have shown that the 1970 law is not be-
ing obeyed. Employers are not telling employees when they are using
hazardous substances, and it seems doubtful that they will be able to
unless they are able to find out the contents of the products that they
purchase for their businesses.

It would be vastly more effective and less expensive, to identify these
substances from the initial manufacturing process onward. Detective
work to identify the ingredients of individual formulated products
come only after they are already in American marketplaces and fac-
tories. The initial producer knows, or can find out, what chemicals he
is using. In the chain of marketing, the level at which a substance is
first introduced is the most effectiA^e and cheapest place to identify it.
At this level, it is nearly always known, or can readily b( determined.
Without the requirement of disclosure by those who develop chemicals
or blend them into products, millions of American workers will con-
tinue to be exposed to substances that can cause disease and death.

537

For some of these substances, there may not be an acceptable sub-
stitute, but there are protective measures available to reduce or elimi-
nate the hazards to health. These protective measures will not be taken
unless the employer and the workers are aware that they are needed.
In 1970, the Congress said that American workers should not have to
pay for their jobs with their health. In this legislation, we have the
opportunity to fulfill the promise of that legislation. The toll of occu-
pationally caused diseases and deaths in our workplaces today makes
using that opportunity an obligation.

Mr. Staggers. With what I have said, Mr. Chairman, I would con-
clude. I believe the time has come when we must do something to pro-
tect the health of the people of America with regard to the new chemi-
cals which are coming on the market, and this is about the only way
we can do it.

I would hope that the EPA, in the administration of the bill, will
use discretion. I think the committee will look into EPA's activities
and see that they administer the bill fairly while protecting the people
of this country.

Mr. Broyhill. Mr. Chairman, I rise in support of this bill. As has
been documented, there are chemicals which have been coming on the
market, new chemicals, by the thousands. Studies have shown that
many of these chemicals, in many cases, are harmful to the health of
humans and the environment. Facts have been presented to the com-
mittee which indicate that streams have been polluted as a result of
dangerous chemicals having been dumped in the streams. The health
of humans is directly affected by their coming in direct contact with
these dangerous chemicals.

There is no legal authority to deal with testing of dangerous chemi-
cals or those that may pose danger to the health or the environment.
We do have laws which regulate disposal of chemicals, but we do not
have any laws relating to the testing of chemicals, that is, to assess the
safety of these chemicals before they are marketed or before exposure
does occur.

So what this bill would do would be to require that the manufac-
turers who bring new chemicals onto the market, or find any new uses
for old chemicals, test them to assure that they are safe for use. This
testing would be done by uniform regulations of EPA and the test
results would be submitted to the EPA in advance of marketing.

Mr. Chairman, .as has been stated, a number of amendments and
compromises have been agreed to in this bill. I think that as a result
of that we have made it a workable bill. I urge that the House adopt
it in its present form.

As a cosponsor of the bill, I want to commend the gentleman from
Texas (Mr. Eckhardt) and the gentleman from New York, (Mr.
Murphy) , the chairman of the subcommittee, and the ranking minority
member of the subcommittee, the gentleman from Nebraska, (Mr. Mc-
Collister) for their hard work and cooperation in working out this
compromise bill. This is balanced legislation. A balance has been
reached between the need to protect health of humans and protection
of the environment, and the concerns of small businesses and other
industrial and marketing problems that give concern.

Mr. Eckhardt. Mr. Chairman, I heard the expressed hope of the
gentleman from Nebraska (Mr. McCollister) that this bill, which is

79-313 0 - 77 - 35

538

well balanced, be retained in its present form in conference. Of course,
in conference there is always a certain give and take which must take
place.

As to this Member's feelings, I would hope that the considerations
and resulting accommodations that I think have made this bill gen-
erally acceptable both to industry and to those concerned with the
environment will in large measure be kept, and I would certainly at-
tempt to keep them. I believe we have a good bill.

We stated out with two deep and somewhat conflicting concerns.
One was the deep concern of .those primarily concerned with health
and the environment that no new^ chemical that is in development
stages will in effect sneak up on us before we have time to do some-
thing about it. On the other side was the concern of industry that we
not adopt such a busybody policy as to interminably investigate, thus
inordinately delaying the final decision so that chemicals could not
flow to the marketplace. Industry insisted that innovation must be
given some freedom of movement.

I believe that initially the Senate's approach was too tight in this
respect. It came very close to embracing premarket screening [Sec. 5].
Under premarket screening no chemical could go into the market
unless it had gone through the governmental screen.

We cannot be 100 percent sure that no danger will exist, no matter
what legislation we pass. On the other hand, the environmentalists
and those primarily concerned with health simply were not satisfied
with an attempt to identify all dangerous chemicals and then let any-
thing we had not thought of before go onto the market without notice.

I believe we have resolved the differences between these two groups
in this act. Within the general parameters of this concept, I feel we
should try to hold the bill to the position of the House. I think we can
do that because I believe we have a good bill. It satisfies those two
legitimate objectives.

Mr. McCoLLisTER. Mr. Chairman, as we proceed to the reading of the
bill for amendment — and there will be amendments — I would simply
like to add to what the gentleman from Texas (Mr. Eckhardt) so
kindly referred to earlier in regard to my interest in small business.
I am very concerned about the impact of this legislation on small busi-
ness. I hope that we have drafted a bill that will protect the interests
of small business as well as the interest of the public.

Whether we have done that or not will, I think, probably be deter-
mined by the attitude of the EPA in administering the law. I would
urge my colleagues to watch very carefully to see how that is done
in order that some remedy can be fashioned, if it is necessary, so that
we will not further concentrate our economic powers in fewer and
fewer companies. I am very much concerned about the impact of this
legislation on small business.

Mr. Metcalfe. Mr. Chairman, I rise in strong support of H.R.
14032, the Toxic Substance Control Act. While the bill before us dif-
fers to some extent from the bill reported out of the Consumer Pro-
tection Subcommittee on which I serve, I nonetheless support the
objectives of this legislation.

Testimony before our subcommittee clearly indicated the need for
this type of legislation.

539

In April 1971, the Council on Environmental Quality released a
report entitled "Toxic Substances." The Council reached the follow-
ing startling conclusion : Several thousand new chemicals are discov-
ered each jrear and we do not know w^hich chemicals and at which level
each chemical causes cancer, genetic mutation, or physical or chemical
defects in offspring.

The Council on Environmental Quality as early as 1971 stated that :

We should no longer be limited to repairing the damage after it has been done ;
nor should we continue to allow the entire population or the entire environment
to be used as a laboratory.

Five years after this report was issued, the Congress is still grap-
pling with a legislative response to this problem. We are still permit-
ting our planet to be used as a giant laboratory and our population to
be used as little more than passive participants in the experiments.

The inadequacy of current law is already documented in the hear-
ing record established by the subcommittee. The point to be stressed
is that we must have control of these chemicals before they are pro-
duced and entered into commerce. For all too long we have directed
our attention to the effect of these toxic substances after the chemical
is in the mass-production stage. W e now propose to establish a schema
whereby we can test and monitor these chemicals before they endan-
ger our fellow man, the environment, and the very planet itself.

Kecent studies of cancer mortality conducted by Drs. Robert Hoover
I and Joseph F. Fraumeni of the epidemiology branch of the National
Cancer Institute show rates of cancer which are far in excess of the
normal rate in 139 counties where there is a high concentration of
cliemical production facilities. The National Cancer Institute estimates
that as high as 90 percent of all human cancer is environmentally
caused. The World Health Organization estimates are as high as 85
percent.

Mr. Chairman, we either learn to control those products which are
having a deleterious effect on the environment and on our fellow

I human beings or we will continue to endanger the health and well-
being of generations to come.

The committee report clearly indicates that this bill is a major step
forward. It does this primarily "through its testing and prefnarket
notification provisions." Thus, the bill "provides for the evaluation of

I the hazard-causing potential of new chemicals before commercial

' production begins."

Mr. Slack. Mr. Chairman, due to the particular problems of small
business, the costs of testing are critical. The "basis for the legisla-
tion" section of the "report" accompanying TSCxi — page 5 — men-
tions that there are significant new methods which reduce the time
required and the costs of testing for the cancer-causing properties of
chemicals. The Ames test is specifically noted. Can we assume that the
Ames test will be accepted as an effective indication of the carceno-
genicity of new compounds ?

Section 8(a)-(l)(A)&(B) generally exempts the small manufac-
turer from the reporting provisions of the bill. However later para-
graphs (8(a)-(3)(A) (i) and (ii)) detail broad instances where this
exemption may be canceled by the Administrator. Due to the general

|i financial inability of small businesses to resist in court, they are anx-

540

ious to be protected from arbitrary administration. Are there any
assurances that can be given that real justification will be present
before reporting will be required by small manufacturers ?

In the same vein, section 3(2)(B)(i) excludes mixtures from juris-
diction, however later sections— 4, 6, and 7 — give the Administrator
authority to include mixtures where deemed necessary. Since most
small chemical manufacturers produce primarily mixtures, the exemp-
tion is critical. What assurances can be offered against arbitrary action
on the case of: being required to report and test due to supposed
"indications" that a hazard may exist? And being required to report
and test due to supposedly "insufficient" data on a mixture?

Can some instances be hypothesized where a mixture might be re-
quired to comply as above?

Section 2(b)(3) states that there is no intention to impede or create
unnecessary economic barriers to technical innovation. There are a
group of specialized small companies who are engaged in the manu-
facture of highly sophisticated intermediate compounds which are
marketed to other chemical concerns, universitieSj^ et cetera, who use
these compounds as starting points in wide-ranging research. The
demand for these chemicals is such that very small amounts of a large
number of substances are produced annually. Since revenues from
the sale of substances produced in such small quantities could not
reasonably be expected to be sufficient to defray the costs involved
in reporting and testing as could be required under the act, it is con-
ceivable that these manufacturers might be forced to stop making
these important items. Is there any way that these chemicals are
exempted under the act as it now reads ?

Section 5 establishes the 90-day period by the end of which the
Administrator must take action on a substance of which he has been
notified. A 90-day extension is also provided where deemed necessary.
It seems possible that an agency deluged with newly reported chem-
icals might be tempted to require testing, on the basis of insufficient
data, rather than take a chance on not objecting to a substance which
they have not been able to find time or manpower to properly review.
Are there assurances that this will not be the case?

Mr. MuRPJiY of New York. Mr. Chairman, the Ames test is cer-
tainly an exciting new testing method, and I would expect the Ad-
ministrator to make considerable use of it. Especially with respect to
organic chemicals, the Ames test should be particularly useful in
determining if a chemical should be regarded as a carcinogen.

The bill requires specific justifications before reporting [Sec. 8]
can be required of small companies. I assure you that my subcom-
mittee will exercise careful oversight to see that the standards in the
bill are adhered to.

Likewise, the bill sets out careful standards before mixtures can be
subjected to testing or before reporting can be required. In addition
to judicial review to strike down action by the Administration act-
ing outside the bounds of the bill, my subcommittee will exercise
very careful oversight to protect against abuses.

These chemicals are not exempted per se. However, before they can
be subject to regulation, there must be a finding by the Administra-
tor tliat the chemical may be hazardous. In making such a determina-
tion, the Administrator obviously will have to consider the quantities

541

and the use of the chemical. The risk must be unreasonable in light
of the use and amount produced or likely to be produced.

The language of the bill does not permit this result. Only in situ-
ations where there is insufficient information and the possibility of an
unreasonable risk can production be stopped.

Mr. AsHBROOK. Mr. Chairman, I rise in opposition to H.R. 14032,
the toxic substance control bill. This legislation would have severe
repercussions on the Nation's chemical industry, pushing up prices,
impeding research and development of new products that would aid
the public and driving small firms out of business.

I want to make it clear that I support reasonable legislation to
strengthen the control of toxic substances. The Government has a
responsibility to protect the public from harmful chemicals and sub-
stances. We must not neglect matters of human health and environ-
mental safet}^

I cannot support H.E. 14032, however, because of its overburden-
some regulations. These regulations would result in massive reporting
requirements, yards of redtape and high costs.

Most disturbing is the part of the bill requiring premarket noti-
fication and screening of new chemical substances [Sec. 5]. The En-
vironmental Protection Agency would be empowered to require
manufacturers to give the Agency advance notification of their intent
to market new chemicals. The Agency could also require manufac-
turers to conduct tests prescribed by the EPA. In addition, the EPA
would be authorized to promulgate rules on the manufacture, proc-
essing, use and disposal of a chemical.

Under the provisions of H.R. 14032, manufacturers of all new chem-
icals as well as existing chemicals with new uses would have to notify
EPA 90 days in advance of manufacturing or marketing. At that
time they would also have to furnish EPA with specified information.

This may look good on the surface. The problem, however, is that
there are approxilnately 2 million known chemical compounds with
about 25,000 new ones added each year. Although most of these are
confined to the laboratory, there are roughly 30,000 chemicals in com-
mercial production. And that number is growing by 700 to 1,000 each
year.

Consequently, it would be very difficult for EPA to give its ap-
proval in the time allowed. Manufacturing of a new chemical could
be delayed for as jnuch as 6 months simply because of administrative
backlog.

Furthermore, the potential cost of this legislation is staggering. Ac-
cording to industry estimates, the cost could range between $358 mil-
lion and $1.3 billion annually. The testing of a single chemical alone
could run into the hundreds of thousands of dollars.

These regulations would be bad enough for large companies, re-
sulting in higher product costs and less development of new products.
For small companies, however, the impact would be even more disas-
trous. The expensive reporting requirements, filing fees and testing
procedures would place a severe strain on their financial resources.

Small chemical companies play an important role in the economy
of our Nation. Of the 11,000 chemical companies now operating, over
10,000 of them are small. It would be tragic if the Congress passed
legislation pushing these small companies into oblivion. It would be
tragic to create a situation where only the large companies can survive.

542

The Chairman. Pursuant to the rule, the Clerk will read the com-
mittee amendment in the nature of a substitute recommended by the
Committee on Interstate and Foreign Commerce, now printed in the
reported bill as' an original bill for the purpose of amendment.

The Clerk read as follows:

Be it enacted by the Senate and House of Representatives of the United States
of America in Congress assembled,

SHORT TITLE

Section 1. This Act may be cited as the "Toxic Substances Control Act".

TABLE OF CONTENTS

Sec. 1. Short title.

Sec. 2. Findings, policy, and intent.

Sec. 3. Definitions.

Sec. 4. Testing of chemical substances and mixtures.
Sec. 5. Manufacturing and processing notices.

Sec. 6. Regulation of hazardous chemical substances ajid mixtures.
Sec. 7. Imminent hazards.

Sec. 8. Reporting and retention of information.
Sec. 9. Relationship to other Federal laws.

Sec. 10. Research, collection, dissemination, and utilization of data.
Sec. 11. Inspections.
Sec. 12. Exports.

Sec. 13. Entry into customs territory of the United States.
Sec. 14. Disclosure of data.
Sec. 15. Prohibited acts.
Sec. 16. Penalties.

Sec. 17. Specific enforcement and seizure.

Sec. 18. Preemption.

Sec. 19. Judicial review.

Sec. 20. Citizens' civil actions.

Sec. 21. Citizens' petitions.

Sec. 22. National defense waiver.

Sec. 23. Employee protection.

Sec. 24. Employment effects.

Sec. 25. Studies.

Sec. 26. Administration of Act.

Sec. 27. Development and evaluation of test methods.
Sec. 28. Authorization for appropriations.
Sec. 29. Annual report.
Sec. 30. Effective date.

Mr. ^luRPHY of New York (during the reading). Mr. Chairman,
I ask unanimous consent that section 1 be considered as read, printed
in the Record, and open to amendment at any point.

The Chairman. Is there objection to the request of the gentleman
from New York?

There was no objection.

The Chairman. Are there any amendments to section 1? If not,
the clerk will read.

The clerk read as follows:

FINDINGS, POLICY, AND INTENT

Sec. 2. (a) Findings. — The Congress finds that —

(1) humans and the environment are being exposed to a large number
of chemical substances and mixtures each year;

(2) among the many chemical substances and mixtures constantly being
developed and produced are some whose manufacture, processing, distribu-
tion in commerce, use, or disposal may cause or significantly contribute to
an unreasonable risk to health or the environment ; and

(3) the effective regulation of interstate commerce in such chemical sub-
stances and mixtures also necessitates the regulation of intrastate commerce
in such chemical substances and mixtures.

(b) Policy. — It is the policy of the United States that —

(1) hazardous and potentially hazardous chemical substances and mix-
tures should be adequately tested with respect to their effect on health
and the environment and that such testing should be the responsibility of

54a

those who manufacture and those who process such chemical substances
and mixtures ;

(2) adequate authority should exist to regulate chemical substances and
mixtures which cause or significantly contribute to an unreasonable risk
to health or the environment, and to take action with respect to chemical
substances and mixtures which are imminent hazards ; and

(3) authority over chemical substances and mixtures should be exercised
in such a manner as not unduly to impede, or to create unnecessary eco-
nomic barriers to, technological innovation while fulfilling the primary pur-
pose of this Act to assure that such innovation and commerce in such
chemical substances and mixtures do not cause or significantly contribute
to an unreasonable risk to health or the environment.

(c) Intent of Congress. — It is the intent of Congress that the Administrator
shall carry out this Act in a reasonable and prudent manner, and that the Ad-
ministrator shall consider the environmental, economic, and social impact of
any action the Administrator proposes to take under this Act.

The Chairman. Are there any amendments to section 2? If not, the
the Clerk will read.
The Clerk read as follows:

DEFINITIONS

Sec. 3. As used in this Act :

(1) The term "Administrator" means the Administrator of the Environmental
Protection Agency.

(2) (A) Except as provided in subparagraph (B), the term "chemical sub-
stance" means —

(i) any organic or inorganic substance of a particular molecular identity
including a combination of such substances occurring (I) in whole or in
part as a result of a chemical reaction or (II) in nature, or

(ii) any element or uncombined radical.
( B ) Such term does not include —

(i) any mixture,

(ii) any pesticide (as defined in the Federal Insecticide, Fungicide, and
Rodenticide Act) when manufactured, processed, or distributed in com-
merce for use as a pesticide,

(iii) tobacco or any tobacco product,

(iv) any source material, special nuclear material, or byproduct ma-
terial (as such terms are defined in the Atomic Energy Act of 1954 and
regulations issued under such Act) ,

(v) any article the sale of which is subject to the tax imposed by section
4181 of the Internal Revenue Code of 1954 (determined without regard to
any exemptions from such tax provided by section 4182 or 4221 or any
lOther provision of such Code) , and

(vi) any food, food additive, drug, cosmetic, or device (as such terms are
defined in section 201 of the Federal Food, Drug, and Cosmetic Act) when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic, or device.

The term "food" as \ised in clause (vi) of this subparagraph includes poultry
and poultry products (as defined in sections 4(e) and 4(f) of the Poultry Prod-
ucts Inspection Act), meat and meat food products (as defined in section l(j)
of the Federal Meat Inspection Act), and eggs and egg products (as defined in
section 4 of the Egg Products Inspection Act) .

(3) The term "commerce" means trade, trafllc, or transportation (A) between
a place in a State and any place outside of such State, or (B) which affects trade,
traffic, or transportation described in clause (A).

(4) The term "distribute in commerce" or "distribution in commerce" when
used to describe an action taken with respect to a chemical substance or mixture
or article containing a substance or mixture means to sell, or the sale of, the
substance, mixture, or article in commerce; to introduce or deliver for intro-
duction into commerce, or the introducing or delivery for introduction into com-
merce of, the substance, mixture, or article ; or to hold, or the holding of, the
substance, mixture or article after its introduction into commerce.

(5) The term "environment" includes water, air, and land and the interrela-
tionship which exist among and between water, air, and land and all living
things.

544

(6) The term "health and safety study" means any study of any effect of a
chemical substance or mixture on health or the environment, including epidemio-
logical studies, studies of occupational exposure to a chemical substance or mix-
ture, toxicological, clinical, and ecological studies of a chemical substance or
mixture, and any test performed pursuant to this Act.

(7) The term ''manufacture" means to import, produce, or manufacture.

(8) The term "mixture" means any combination of two or mare chemical
substances if the combination does not occur in nature and is not, in whole or in
part, the result of a chemical reaction ; except that such term does include
combination which occurs, in whole or in part, as a result of a chemical reaction
if each of the chemical substances comprising the combination is not a new
chemical substance and if the combination could have been manufactured for
commercial purposes without a chemical reaction at the time the chemical sub-
stances comprising the combination were combined.

(9) The term "new chemical substance" means any chemical substance not
included in the chemical substance list compiled and published under section
8(b).

(10) The term "process" means the preparation of a chemical substance or
mixture for distribution in commerce —

(A) in the same form or physical state, or in a different form or physical
state from that, in which it was received by the x)erson making such prepa-
ration, or

(B) as part of an article containing the chemical substance or mixture.

(11) The term "processor" means any person who processes a chemical sub-
stance or mixture.

(12) The term "standards for the development of test data" means a pre-
scription of —

(A) th^

(i) health and environmental effects, and

(ii) information relating to toxicity, persistence, and other charac-
teristics which affect health and the environment, for which test data
for a chemical substance or mixture are to be developed and any
analysis that is to be performed on such data, and

(B) to the extent necessary to assure that such data are reliable
and adequate, the manner in which such data are to be developed, the
specification of any test protocol or methodology to be empK)yed in the
development of such data, and such other requirements as are neces-
sary to provide such assurance.

(13) The term "State" means any of the several States, the District of Co-
lumbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Canal
Zone, American Samoa, or the Trust Territory of the Pacific Islands.

(14) The term "United States", when used in the geographic sense, means all
the States.

AMENDMENT OFFERED BY MR. HAGEDORN

Mr. Hagedorx. Mr. Chairman, I offer an amendment.
The Clerk read as follows :

Amendment offered by Mr. Hagedorn: On page 105, line 15. [Sec 3(2)(B)(i)]

insert the following after the comma "including those combinations which would
be mixtures but for the exclusion of all their component substances from the list
drawn up by the Administrator pursuant to section 5(c)(2)(A)(i),". On page
108, line 5, [Sec. 3(8)] substitute a comma for the period and add the following
"provided that the combination contains component substances listed by the
Administrator pursuant to section 5(c) (2) (A) (i)."

Mr. Hagedorn. Mr. Chairman, the purpose of my amendment is to
exempt from the act mixtures which contain no chemicals contained
on the section 5(c) (2) (A) (i) list. This list is to be compiled by the
Administrator of EPA and is to contain chemical substances which
might significantly contribute to an unreasonable.- risk to health or the
environment.

Although "mixtures" are explicitly excluded from the definition of
"chemical substance" on page 105, the effect of this is only to exclude
them from the operations of section 5 premarket notification pro-

545 V

cedures. They remain potentially subject to the entire n^tJvfork of regu-
lations and recordkeeping contemplated by the rest of the act.

Mixtures are unlike other chemical formulations in the respect that
the component elements do not have their chemical properties altered.
Generally, they are as safe or unsafe as their components. While mix-
tures may result in the alteration of the physical properties of the
components, as in shampoos or dish detergents, they retain the same
chemical qualities as the substances which comprise them. There is no
reason to burden chemical companies Avith the retesting of mixtures
which simply partake of the qualities of their components, which have
already been admitted to the marketplace. If they have not been, then
the premarket notification requirements could be applied to the indi-
vidual components, rather than requiring the entire mixture to be
tested.

The great majority of the smaller chemical companies in this
country make nothing but formulations of chemicals that are ac-
cepted as safe. If they are not, the Administrator always has the op-
tion, under any amendment, to place them on his section 5 list. If they
are safe. I see no reason to subject these manufacturers to the ex-
tremely heavy testing and paperwork burdens of the bill. I believe
that my amendment would markedly streamline the bill by requiring
EPA to concentrate its focus on those chemicals which he considers
harmful.

Most of the larger chemical companies say that they can live with
this bill ; that may be. The smaller chemical companies, however — the
ones that produce 100 formulations and employ 50 to 100 people —
they cannot live with this quite so easily. They cannot afford to hire
new bookkeepers and paper-shufflers to comply with EPA regulations,
they cannot afford the high-power legal staffs to challenge abuses of
EPA authority, and they cannot afford legislative liaisons to work
hand in hand with Congress in drafting and amending legislation
to 3uit their needs. The Small Business Administration has already
estimated that the average small chemical company spends approxi-
mately 10 percent of their pretax profits to comply with existing EPA
rules. One small company in my district, employing less than 100 per-
sons, claims that it is spending well over 25 percent of their time of
Government compliance activities, nearly six times the amount spent
only 3 years ago.

There has got to be some recognition of cost-benefit relationships by
Congress. The smaller the company, the greater is the ratio of time
spent testing and conforming to EPA edict to the volume of chemicals
produced. There is no alternative for the small formulator but to hire
new personnel that he cannot afford.

Finally, I am aware of the provisions in this bill that either give lip
service to the small manufacturer, or distinguish between the treat-
ment given chemical substances and mixtures. I have yet to speak to
a small manufacturer, however, who feels comfortable with these.
As one of them said to me —

The people who drew up this bill seem to assume EPA will act reasonably. On
the basis of past experience, I have to assume otherwise.

I read section 4(a)(2) as imposing that section's testing require-
ments upon all mixtures unless the Administrator makes certain find-

546

ings that such testing will be duplicative or wasteful. To do this, un-
doubtedly he will have to overcome the presumption that the testing of
chemical components is insufficient to enable conclusions about the
mixture. Hearings may be required, rules necessitated, and civil suits,
by those groups assuming that man is an intruder upon his environ-
ment, may have to be overcome.

Opponents of eliminating mixtures from the act argue that they
may sometimes result in a synergistic effect, whereby the mixture takes
on additional qualities beyond the qualities of the components. Al-
though a detrimental synergistic effect may occur in one in a million
mixtures, this bill may end up requiring the testing of the million in
order to uncover the exception. Chemical producers rarely test their
chemicals for every conceivable purpose to which they might be put.
The Administrator would have extremely broad discretion under the
act to contend that a chemical had not been tested for a particular ap-
plication; hence, requiring additional testing for that application.
Once the Administrator argues — correctly — that the hazard is always
in the application of a chemical, the exemptions in this bill are effec-
tively rendered meaningless.

The committee states that it has limited the Administrator to taking
action only against unreasonable risks because to do otherwise as-
sumes that a risk-free society is attainable, an assumption that the
committee does not make. The inclusion of mixtures in this bill does
not comport with that premise. Eather than requiring EPA to take
affirmative action to exclude a mixture from testing, the resources of
EPA — and the chemical industry — could far more properly be used
if affirmative action was required prior to inclusion. Neither my
amendment, nor the bill will do anything about the basic problem in-
volved— abuse and misuse of chemicals ; where, however, the chemical
itself is the problem, I believe that my amendment strikes a far more
reasonable balance between environmental and economic concerns.

Mr. McCoLLiSTER. Mr. Chairman, I would like to have some clarifi-
cation of the gentleman's amendment. Is it the gentleman's intent that
the Administrator of EPA should be able to exempt the testing of mix-
tures if the component parts of that mixture can be tested?

Mr. Hagedorx. Yes, if they have been tested.

Mr. McCoLLiSTER. If they have been tested.

Mr. Hagedorx. If they are listed as a priority or a section 5 chemi-
cal, then certainly they ought to be tested. If they are not included in
the EPA list, then it is my feeling that they ought to be excluded,
unless the EPA Director can show good cause for inclusion, which is
still his discretion.

Mr. McCoLLiSTER. In section 4, the testing section, at the bottom
of page 110, line 21, it says:

[Sec. 4(a)] (2) in the case of a mixture, the effects which the mixture's manu-
facture, distribution in commerce, processing, use, or disposal or any combination
of such actions may have on health or the environment may not be reasonably
and more efficiently determined or predicted by testing the chemical substances
which comprise the mixture ; '

In other words, the Administrator has the options ?

Mr. Hagedorn. Yes.

Mr. McCoLLiSTER. It is not mandatory ?

Mr. Hagedorn. Right.

547

Mr. McCoLLisTER. He has the option of exempting the mixture from
tests if the component parts have been tested ?

Mr. Hagedorx. That is true, but the presumption of innocence
always has to be found on that chemical where we are reversing a
finding of fault or of possible harm, and putting that burden on the
EPA Director to evaluate the mixture as to its potential harmful
effects.

Mr. McCoT.LisTER. And the gentleman's testing of the components
would be limited to only those chemicals that are on the list, that have
a hazardous chemicals listing?

Mr. Hagedorx. If the gentleman will yield further, certainly any
of those lists can be expanded. If the EPA Director so chooses to in-
clude them, then my amendment would have no effect. I am not arguing
that point. I am only talking about the unlisted chemicals not on the
priority list or section 5 list as being included.

Mr. McCoLLTSTER. I thank the gentleman.

Mr. EcKHARDT. Mr. Chairman, I rise in opposition to the amend-
ment.

Mr. Chairman, I must say at the outset that I had great difficulty in
understanding what this amendment means. It is an addition that is
sought to be added after the term "mixture" on line 15 [Sec, 3(2) (B)

(1) ], providing including those combinations which Avould be mix-
tures, but providing for tlie exclusion of all their component substances
from the list drawn up l)v the Administrator pursuant to section 5(c)

(2) (A)(i).

I do not see where section 5(c)(2)(A) (i) w^hich is contained on page
. 127 of the act, excludes things from the definition of "mixture" at all.
I simply do not understand what the gentleman is trying to do. In
the bill we provided that wherever possible, and unless a rule were
made by the Administrator, testing of the ingredients of the mixture
would be enough, and only in the event that that was not enough and
found not to be, and positive action taken by the Administrator would
a mixture have to be tested separately.

In the argument in favor of the amendment it seems to me that the
author seems to reach much further and go to the proposition of ex-
cluding everything that has not previously been identified on the list
provided for in [Sec. 5(c) ] (2) (A) (i). I. frankly, do not understand
j what the amendment is attempting to get at. It seems to me that, if the
, amendment is tryii^g to force the Administrator to leave alone a mix-
I ture that is properly tested because its ingredients are tested, the bill
already takes care of that proposition. If it goes further than that, I
do not agree that we should go further than that. I think it would be
in opposition to the major thrust of the bill.

Mr. Hagedorx. I think what we are doing here, Mr. Chairman, is
reversing the finding of fault. In other words, the chemical is presumed
to be noncarcinogenic and nontoxic, unless the EPA Director, looking
at the components involved in that mixture, concludes that it could be
harmful.

INIr. EcKHARDT. We do not create any presumption of danger in the
bill as it stands. "We required in every instance that the EPA take the
laboring oar in identifying the danger or else the chemical flows to
the market. And even Avhen the EPA does identify a potential danger,
and says. "We cannot determine positively whether it is safe or it is

548

not safe and, therefore, we cannot act finally," the EPA cannot make
a ruling and keep the chemical off of the market. It flows right into
the market just the same, unless an order by a court determines that,
because of the great quantity of the substance going into the market-
place— and potentially into the environment — or because of the great
risk involved that cannot be positively ascertained, harm would be
done unless an injunction is issued.

We have tried to avoid the evil that the gentleman very properly
points out, the evil of creating a presumption of risk without any proof
of it, the evil of making the defendant prove himself not guilty with
respect to the chemical. We put the burden on the EPA to identify the
danger in every respect. I cannot see how the language of this amend-
ment improves the bill and I think it might do mischief which might
be inadvertent as far as the author is concerned.

I would urge that the committee vote against the amendment.

Mr. Hagedorn. Mr. Chairman, if the gentleman would yield further,
we are not trying to be mischievous, that is for sure, with this legisla-
tion. What we are attempting to do is to insure we will not put undue
burdens on the small businessmen as far as testing, the small business-
men who will be manufacturing the vast majority of chemical sub-
stances. But with my amendment we will not give EPA any additional
powers unless they act in a positive manner indicating that certain
mixtures may have a potential of being toxic or carcinogenic agents
and will be taken off. Otherwise there will not be testing requirements
placed on that small manufacturer. That is my intent.

Mr. McCoLLiSTER. Mr. Chairman, if I might have the attention of
the gentleman, as far as the comment he just made, I want to repeat
that is my understanding of the bill the way it is now, that testing is
required only when there is an unreasonable risk imposed and if there
is no such risk no testing is required. Further the Administrator is told
both by the language of the bill and by the comment of the gentleman
from Texas a moment ago, that with the testing of the basic com-
ponents, if that has been accomplished, then the testing of the mix-
ture ought not to be required since the testing of the components has
been made.

Mr. Hagedorn. But the intent, Mr. Chairman, if the gentleman will
yield, would be to exempt those chemicals not under section 5 or the
list, they would be eliminated unless they are added in an affirmative
manner to the required testing.

Mr. McCoLLiSTER. As far as the required testing.

Mr. Hagedorn. Yes.

Mr. Smith of Iowa. Mr. Chairman, if the gentleman will yield, how
will the manufacturer know what is required to be tested?

Mr. McCoLLisTER. He will know because it will be on the list and be-
cause there is a rulemaking process by which a potentially dangerous
chemical is judged to be a dangerous chemical, and then there follows
the testing of it and all other requirements associated with it, and
the manufacturer will have notice through the usual processes and in
the Federal Register, and in the lists.

Mr. Eckhardt. Mr. Chairman, if the gentleman will yield, actually
I think the author of the amendment may be under the misconception
that merely by identifying a chemical the EPA may require testing.
Actually of course there is a rulemaking process which must determine

549

that the chemical poses the risk and should be tested in order to deter-
mine whether or not the risk is in actuality.

I am inclined to think that the terms of the act may be even stricter
than the gentleman may conceive in his amendment because we do not
permit the EPA merely by putting the chemical on the list to require
its testing. The EPA must identify the chemical and by rule direct
testing in the case.

Mr. McCoLLiSTER. Mr. Chairman, if the gentleman will yield back
to me, that rulemaking process is a good deal more different and more
stringent and more formal, Avith cross-examination and substantial
evidence and so forth, than the rulemaking processes we usually asso-
ciate with what the earlier legislation provided.

Mr. EcKHARDT. Mr. Chairman, if the gentleman will yield further,
it is not quite so with respect to the testing rulemaking, because we
do not want to overload an intermediate process to identify danger or
to show that it does not exist. Where we put in the complete cross-exam-
ination rights is with respect to keeping the chemical ultimately off
the market or limiting its entry into the market.

Mr. Smith of Iowa. Mr. Chairman, I am concerned about this kind
of legislation. I know the committee did its best to try to work out
something acceptable and that the overriding reason for the legislation
is to protect people. But, I think we have gone too far in running small
business out of business in this country. Even if all they have to do is
watch the Federal Register, it is too much for many small business-
men that are in this business.

Mr. Chairman, take for example a small business. One of them tells
me he last year sold 300 formulations. He may only sell 1 ton of a
certain product. He cannot afford to watch the Federal Register. He
does not have time to watch the Federal Register all the time.

Mr. Ottixger. Mr. Chairman, the gentleman does not want to say
that we want small business to be permitted to poison the populace?
There has to be some protection here.

Mr. Smith of Iowa. No. If the gentleman will listen. I am saying
that it is not enough to work out an agreement with the big companies
as to what will satisfy them and forget small business. That is what the
committee did in this bill. It does something for companies like Du
Pont but forgets all about small business. They did not even know this
bill was under consideration until it was out of the full committee.
How are they going to know how to protect themselves ?

Mr. EcKHARDT. Will the gentleman please heed me on this? This bill
has been before the Congress, or this concept has been before the Con-
gress in a series of bills, for 5 years. There were full hearings in both
the Senate and in the House in at least two terms of Congress. There
was full opportunity and notice to everyone involved.

Mr. Smith of Iowa. How do you give notice to all these manu-
facturers out there working 40, 50, and 60 hours a week in their plants
making a livinor? How do they know what you are doing?

Mr. EcKHARDT. Mr. Chairman, if the gentleman will yield further,
are thev going to manufacture poisons in their plants?
I Mr. Smith of Iowa. Oh, no, it is not poison.

- ^ I just want to give this example. This manufacturer mixes coconut
oil with some other reactants to form a wetting agent for washing
floors. If he buys that from Du Pont, it costs twice as much as if he

550

mixes it in his own plant. That is what this legislation does to small
business. Tliat is what it does to people who buy the product. It makes
them buy it at a much higher price then they would have to. This legis-
lation does for large companies what they are not allowed to do under
the antitrust laws. It runs small business out of business by making it
so expensive. They are subject to $2,500 fee or they have to come to
Washington to see the EPA. Or they may have to get the Congres-
sional liecord and watch it every day and to hire legal help. Many
small businesses cannot operate that way, but the big companies can
and after running their small business competition out of business,
they can triple and quadruple their prices. That is what happens under
too much of this kind of legislation.

Mr. EcKHARDT. Mr. Chairman, if the gentleman will yield further
the gentleman gave an example of a company mixing coconut oil with
a compound for cleaning floors. Xo. 1, tlie chances are there is no rule
made with respect to testing either product.

Mr. Smith of Iowa. How is this small businessman going to know
there is a rule for that ?

Mr. EcKHARDT. If there were a rule on that, the person producing the
active ingredients in the product would be the one to give notice, not
the man mixing the two compounds, because if the basic components
had been tested he is under no responsibility.

Mr. Smith of Iowa. We are forcing him to go to see a "Philadelphia
lawyer". He would have to watch the Congressional Record and he
would be afraid to be in business at all. If they catch one of them in
some violation, if one slips up, he will be out of business and then
others are afraid.

I think we have passed too much of this kind of legislation. I know
it is worked out so big companies will be satisfied, but I think we ought
to work it out for small business in this country. I understand tlie need
to protect people, but we have gone too far. This is not the only bill in
which we have been doing this. Month after month, we pass additional
legislation. The importance of it and the intent of it is good, but it goes
too far.

I think we have got to come to the time when we, as Members of Con-
gress, are watching out for these people who are not here for the hear-
ings, who are not here to have their side of the story heard. In fact,
many of them do not even know what is about to be done to them, and
they will not know until they find out in the newspaper, about a month
or 2 months from now, that this bill has passed.

What I am saying is that it is too burdensome to make the little
manufacturer pay up to $2,500 in fees, to come to Washington and get
permission from the EPA, and file numerous papers. There are too
many legalities, and somehow we have to work it out better than what
has been done in this bill.

Mr. Ottinger. Fii*st of all, small chemical manufacturers do have
an association, and they were heard. We did make provision for the
small manufacturers in the bill.

Mr. Smith of Iowa. The "gentleman gave sofne discretion to the
agency to make exemptions. That is not the same thing.

Mr. Ottinger. It is my understanding that the committee is going
to waive the fees for small business, even further aiding small business,
in an amendment that is going to be offered. I do think we have con-

551

sidered small businesses and their problems, but their inclusion is
vitally important because the incidence of cancer has grown so rapidly
from environmental causes.

Mr. Smith of Iowa. What we are doing here primarily is running
small businesses out of business, and helping big companies to take
more business and do what they could not do under the antitrust laws
to run the small businesses competitors out of business.

Mr. Ottinger. There is nothmg in this bill which forces a man to
buy from Du Pont if he is using a mixture of two chemicals that have
already been tested.

Mr. Smith of Iowa. If the people buying a few^ tons from this little
manufacturer cannot buy it from him because he is no longer in busi-
ness because fees are too high, they are going to have to buy it from a
big company at a much higher cost.

Mr. Ottinger. We are not going to drive him out of business unless
his business is introducing toxic substances into the environment.

Mr. Smith of Iowa. He gets driven out if he does not have a place
to sell his product.

Mr. McCoLLiSTER. W^ould the gentleman consider transferring from
the Budget Committee to the Committee on Interstate and Foreign
Commerce, where we need him badly ?

Mr. Smith of Iowa. I appreciate the compliment but I doubt that
it would make that much difference.

Mr. Hagedorx. I want to commend the gentleman from Iowa for his
very appropriate remarks as to what the impact of this legislation can
be on the small businessman, because this is where new compounds are
coming out. When we talk about poisons in our society today, it is true
that there are a few that are mishandled and misused; but there are
hundreds, literally thousands, of different compounds that are safe
for society in a very positive way. I think we ought to look at it from
that basis as well.

Mr. Smith of Iowa. There is surely some way we can protect so-
ciety without running out competition and running up the price.

Mr. Murphy of New York. Mr. Chairman, I can understand the
concern of my colleague from Minnesota in offering this language, but
I think the needed protection is already provided. Throughout the
hearings and throughout the markup session, the committee carefully
considered and evaluated the effects on small business, and built safe-
guards into this legislation for the small businessman.

The committee does not feel and I do not feel that we can exempt
certain mixtures and substances. We have so carefully considered and
responded to small businesses. We have responded to the small business
associations and re])resentative groups which are here in Washington
and across the country. This is the type of response that we have re-
ceived in committee from their inquiries and from our reaction to those
inquires, and this is an example of one such from a small company
in Iowa. It says :

Dear Mr. Murphy : Thank you for your very comprehensive reply to our in-
quiry into the Toxic Substance Control legislation. In all of the replys from other
members of Congress, we were not granted such a detailed and clear cut under-
standing of this bill. The other replys were vague or down-right pro T.S.C.A.

Since we first became aware of this bill, April of this year, our future plans
have been in a state of limbo. Now, with the receipt of your letter we feel that
we can get back to business without the threat of the second shoe hanging over
our head.

562

By design, we are a very small regional company that has been successful
through' quality, rather than quantity. We do not subscribe to the theory that
"bigger is better", and have been extremely careful to maintain a close per-
sonal contact with our clienas. The information we received on this bill con-
vinced us that our days were numbered. Now, we will proceed with business as
usual based upon the information which you have supplied.

We have carefully considered small business. We have other amend-
ments that the Members have been kind enough to furnish us with that
we will accept, which further consider small business. But I think in a
consideration of balance and the health of the Nation, we cannot
accept this amendment.

]\Ir. McCoLLisTER. Mr. Chairman, many of those comments which
all of us received I think were directed to the original bill, H.R. 10318.
The work of the gentleman from Texas and the gentleman from North
Carolina to produce H.R. 14032 made it quite different from the
original bill. I think many small chemical companies were concerned,
and justifiably so, about the original bill. I have not heard from any
small chemical companies on H.R. 14032 and the changes we have
made in it.

Mr. Broyhill. Mr. Chairman, I think the key word that was used
by the gentleman from New York (Mr. Murphy) is the word
"balance." We have achieved balance in this bill, and we have taken
into consideration the needs to protect the environment and at the
same time we make sure that we do not do undue harm to the small
business interests or any other commercial interests.

Mr. Hagedorx. Mr. Chairman, I want to thank the gentleman from
New York for his input, and the gentleman from Texas, as well. It can
give reassurance to the small company about the role-making process.

If the gentleman will yield further, I think this has b^en worth-
while from that standpoint alone. When we talk about the role-making
process, that is another matter, where the small company must come in
and bring in his attorneys and legal counsel to fight this, as well, so that
is an added burden, in addition to all the other problems of increasing
costs that they face.

The Chairman. The question is on the amendment offered by the
gentleman from Minnesota (Mr. Hagedorn).

The question was taken; and on a division (demanded by
Mr. Hagedorn) there were — ayes 10, noes 15.

So the amendment was rejected.

AMENDMENTS OFFERED BY MR. FUQUA

Mr. FuQUA. Mr. Chairman, I offer amendments.
The Clerk read as follows:

Amendments offered by Mr. Fuqua : Page 106, line 5 [Sec. 3(2) (B)] strike out
"and" ; at the end of line 10 strike out the period and insert and " ; and after
line 10 insert the following :

"(vii) any chemical substance manufactured or processed in small quantities
(as defined by the Administrator by rule) solely for scientific experimentation or
analysis or chemical research or analysis on such substance or another sub-
stance."

Page 141, strike out lines 6 through 21 [Sec. 5(i)(3)i and redesignate the
succeeding paragraphs accordingly.

Page 159 beginning in line 1 [Sec 8(a)(1)(A)], strike out "(other than a
chemical substance described in subparagraph (B) (ii) ) ".

553

Page 159, strike out lines 8 through 15 [Sec. 8(a)(1)(B)] and insert in lieu
thereof the following: to manufacture or process a mixture,"

Mr. FuQUA. ;Mr. Chainiian, I ask unanimous consent that the
amendments be considered en bloc.

The Chatrmax. Is there objection to the request of the gentleman
from Florida ?

There was no objection.

Mr, FuQUA. Mv. Chairman, I wish to thank the committee for offer-
ing some conciliatory concern about the effects of this legislation on
small business, but what I am concerned about is research chemicals,
those chemicals specifically used for research processes.

I have in my district a small business employing approximately 60
persons, and that business deals solely in research chemicals. These
are not chemicals that one may buy in a drug store; they are not
chemicals that any individual could purchase from another person.
These chemicals are in most cases purchased in very small quantities,
sometimes as small an amount as 1 gram and in other cases perhaps a
hundred grams.

This company offers a catalogue that contains several thousand
chemical formulations that it has the capability of making. They
transport the chemical in public commerce, and it is treated as a toxic
substance. It does not get into the hands of, for instance, some 10th
grade chemistry buff.

AVith all of these complex compounds that they offer solely for
research purposes to universities, to those in research labs, and perhaps
to a few other companies, thev provide a short circuit for the researcher
so that he can work further down the chain of the chemical compound
rather than having to take simple compounds and breaking them down
into these other types of compounds.

T^Hiile we have waived the requirement of their having to pay the
fee and given other considerations, they should be totally exempt from
this because they would then be subject to having to see that every com-
pound is tested and tested until it is proven that it is not toxic. They
realize these compounds are toxic.

One can even go into a store today and buy nitric acid and gflycerine
in separate compounds and then put them together. We know, of
course, what we have then : we have nitroglycerine, which is a very
danfiferous substance.

Mr. Chairman. T plead with tlie committee to consider this amend-
ment favorably. However, I think that in this particular case, in deal-
ing with research chemicals, we are certainly going too far.

One of the more toxic substances that is now made in these labs is
one that is used in one of the compounds for the treatment of cancer.
Here we would l>e subjecting researchers to spending much more time,
and it would probably cost twice as much because of the additional
research necessary.

As I pointed out earlier, these substances do not get into the hands
of incompetent individuals such as myself or any other lay person.
These are research scientists; they are using these substances in uni-
versities, and they are used in other products.

^Ir. Chairman, T believe this is a very, very important amendment.
This bill will produce voluminous amounts of paperwork for the
administration and for the EPA Administrator.

79-313 0 - 77 - 36

554

It would almost be too complicated to handle. There are very few
of these companies in business today. As the gentleman from Iowa
(Mr. Smith) pointed out, these are very small individuals, not the
large companies, even though sometimes they sell research chemicals
to many of the large companies. However, these are small operators.
They do not have attorneys here in Washington or a Washington staff
to be up here every day and to get the permits that would be necessary
for the manufacturing of these chemicals.

Mr. Chairman, I would hope that the committee would see fit to
accept this amendment. I talked to them about it. I think it is also
desirable because of the competitive nature involved, and these are not
large amounts, but very small amounts.

Mr. Chairman, I am informed that with the increased cost involved
these people may probably be forced to go to some other country in
order to produce research chemicals. It is providing jobs in this
country and the expertise that we need plus the technology that we
need in this country.

Therefore, Mr. Chairman, I would certainly hope that the com-
mittee would accept this amendment. I think it goes a long way. It does
not do violence to the purpose and intent of what the committee is
trying to do.

Again, I say I support the committee's position, but I do think that
in this particular instance with respect to research chemicals, those
chemicals should be exempted from this requirement.

Mr. EcKHARDT. Mr. Chairman, the provisions for premarked noti-
fication are contained in section 5 of the bill.

Chemical substances which are for scientific experimentation or
analysis or chemical research or analysis on such substances are
presently exempted from the premarket notification requirement.

Mr. Chairman, this is certainly enough. Mind you, no chemical,
whether it is research or otherwise, is absolutely required to be tested.
Therefore, it would not even come under section 6 providing a ban or
limitation on its use unless there were some very good reason that it
should not be distributed.

Mr. Chairman, it is perfectly proper not to inject control of EPA
with respect to research chemicals for the purpose of notice. In most
instances, since no notice is required, no testing would be applied and
no ban or limitation would bo placed on those chemicals. However,
even if a chemical is produced in small quantities and used for analysis,
it may be so dangerous and it may be so unnecessary to be used in that
particular analysis as to require some limitation on its distribution.

Mr. Chairman, the Fuqua amendment would not only exempt some
chemicals from the notification provisions, but it would also prevent
the administrator, when he finds that the chemical causes or signifi-
cantly contributes to or will cause or significantly contribute to an un-
reasonable risk to health or the environment from applying any of the
remedies contained on page 143 [Sec. 6] and the following pages, a
requirement prohibiting the manufacturing, processing, or distribu-
tion in commerce of such substance or mixture. Nor would it permit
limiting the amount of such substance or mixture, or a requirement
that such substance or mixture or any article containing such substance
or mixture be marked with or accompanied by clear and adequate

555

warnings and instructions with respect to its use or disposal, or with
respect to both.

Mr. Chairman, it seems to me that in many instances it would be most
desirable to notify students, for instance, engaged in analysis, in a
university laboratory by having the mixture marked with accompany-
ing clear and adequate warnings and instructions with respect to its
use.

I give a lot of credit to the teachers in colleges, high schools, and
technical institutions with respect to their expertise but we have some
800 new chemicals coming on the market each year. I think that the
analysts and laboratory workers are entitled to know something about
the dangei^ of those new chemicals. We do not require that those be
covered by pre-market notification but we do leave open the door to a
situation where EPA has determined that this is a most dangerous
chemical, perhaps it is a carcinogen. Why in those instances should we
exempt it, so that we do not extend protection of persons working in
laboratories? I do not think this is going to be abused. We do not re-
quire notification in advance. We cannot require any limitation until
there is a full scale hearing and a ruling as required in section 6 of the
act.

I Mr. FuQUA. Mr. Chairman, I certainly appreciate the concern that

I the gentleman from Texas (ISIr. Eckhardt) is making and I support
that, but the point the gentleman is missing is that these are research
chemists. They take it at face value that they are toxic and that they
are not to breathe them. But research scientists know how to handle
very highly toxic materials, and they can be handled. In addition, they
are using these materials so as to break down other materials, if you
please, to prove their acceptability or toxicity in the open market. So
these materials are not available to just any person. They are available
only to research people and they treat them as highly toxic and as

; something that should not be handled without due care. They are toxic
but they are being handled by people who know chemicals and who

I know how to handle them. I think without that we will be stifling the
very purpose of evaluating many products that later Avill be sold and
that it impedes, really, what the purpose of the act is.

Mr. Eckhardt. Reading from the proposed bill [Sec. 5(i)(3)], it
says :

. . . any chemical substance which is manufactured or processed, only in small
Quantities (as defined by the Administrator by rule) solely for —

' Let us take one of these bases :
. . . for scientific analysis ...

Chemicals may be used for scientific anah'sis in a laboratory by not
very well trained people and if that is done why should not the Ad-
ministrator do what he can do under section 6-^and, incidentally, he
is not going to limit it at all unles he does something under section 6.
Why should he not have the authority to say what the dangers are?
Tliis is a requirement that says any substances, mixtures, or any mix-
\ ture thereof is supposed to be marked and accompanied by clear and
i adequate analysis and instruction. That is not too heavy a burden.
\ Mr. FrqrA.'Mr. Chairman, some of the things that they use in chemi-
[ cal analysis are exotic chemicals that are used to check other chemicals

556

for toxic material and to secure a true analysis. We are only talking
about research chemists, people who know w^hat they are doing, not a
10th grade chenjistry buff, or children playing with chemicals they buy
at a toy store ; we are talking about universities, research laboratories,
professional people trained in this area so that they can use these chem-
icals or their components to break other materials down, so that they
can shortcircuit the work that would otherwise be necessary, so by
using these chemicals they can break these compounds down.

Mr. EcKHARDT. I do not think that the Administrator is going to
restrict that kind of use anyway. In the first place, they are not re-
quired to give notice ; therefore, he is not going to issue a rule requiring
testing. But even if he did, the only limitation he would ultimately
place on some such chemicals is the requirement that instructions be
given concerning their danger. It seems to me that the bill is perfectly
adequate, as written, and there is no reason to alter it in this way.

Mr. T.xURPiiY of New York. Mr. Chairman, I reluctantly oppose the
Fuqua amendment which would exempt chemicals manufactured in
small quantities for scientific experimentation or analysis, or chemical
research or analysis, from the legislation. The reason is that the Fuqua
amendment would create a dangerous loophole in the protection pro-
vided by the legislation, and it is not necessary to protect chemical
research and innovation.

Tl^ bill already makes special provisions for research chemicals in
order to insure that chemical research and innovation is not unduly
impeded. Research chemicals are exempted from the premarket notifi-
cation provisions of the bill. Thus there will be no slowdown in re-
searchers obtaining chemicals they need to conduct their research.

During the subcommittee hearings on the legislation, representatives
of the American Chemical Society, a professional organization com-
prised of more than 110,000 chemists, recommended that research
chemicals be exempted from the premarket notification provisions of
the bill. This the committee has done. The American Chemical Society,
however, did not recommend that research chemicals be exempted
from the other regulatory provisions. When questioned about the need
for such an exemption, the chairman of the American Chemical So-
ciety Board of Directors specifically recommended against it. He
pointed out that chemicals which find their way into supply houses for
sale to anyone who wishes to purchase them are often purchased by
high school students or people Avho have home laboratories. Such
people may need protection from hazardous chemicals.

For example, if Mr. Fuqua's amendment is agreed to, the EPA
could not require a manufacturer of a particularly hazardous research
chemical to place warnings on the chemical, so that high school stu-
dents using the chemical will be informed of the dangers of the
chemical.

Before EPA could take regulatory action against a research chemi-
cal under the bill, the agency would have to find an unreasonable risk
associated with the chemical. This requires that EPA weigh the risks
against the benefits presented by the chemical. The risks would have
to outweigh the research benefits before EPA could take regulatory
action. If EPA can make the requisite showing that even considering
the benefits of the research chemical, the dangers are so great that the
public needs protection, should EPA not be authorized to take such

557

necessary protective action ? This does not necessarily mean that the
chemical will be banned. All that may be necessary are warning labels.
Or it may be necessary to prescribe disposal techniques.

It is instructive to note that other existinor laws which regulate
chemicals do not provide total exemptions for research chemicals. For
example, the Food, Drug, and Cosmetic Act does not exempt chemicals
used for research for drugs. Like the toxic substances bill, research
drugs are exempted from the premarket clearance provisions. How-
ever, if FDA determined that a research drug were unreasonably
endangering public health, it could act to protect against it.

Thus the Fuqua amendment is totally unnecessary to protect against
chemical research and development. Further, it creates a gap in the
protections pro\ ided by the bill. Therefore, it should be defeated.

Mr. Broyitti.l. I want to compliment the gentleman for giving a very
adequate explanation of the many provisions in a bill that do exempt
research chemicals from provisions of this bill. But would the gentle-
man not agree with me that striking the reportinof requirements alto-
gether would not be wise, because there is one thing the EPA should
have, and that is adequate knowledge of the new chemicals that are
being developed ?

Mr. ]\IrRPHY of Xew York. That is one of the thrust of this bill.

!Mr. Broytiill. That is not certainly an onerous burden to know the
formulas of new chemicals that are being developed, is it ?

Mr. MuRPiiY of Xew York. It is not.

The Chairman. The question is on the amendments offered by the
gentleman from Florida (Mr. Fuqua).
The amendments were rejected.

The Chairmax. There being no further amendments to section 3,
the Clerk will read.

Tlie Clerk read as follows :

TESTING OF CHEMIG^L SUBSTANCES AND MIXTURES

Sec. 4. (a) Testing Requirements. — If the Administrator finds that —
(l)(A)(i) the manufacture, distribution in commerce, processing, use, or
disposal of a chemical substance or mixture or any combination of such actions
may cause or significantly contribute to an unreasonable risk to health or the
environment.

(ii) there are insufiicient data and experience upon which the effects of
such manufacture, distribution in commerce, processing, use, or disposal
or combination of such actions on health or the environment can reasonably
be determined Dr predicted, and

(iii) testing of such substance or mixture with respect to such effects is
necessary to develop such data ; or

(B) (i) a chemical substance or mixture is or will be produced in sub-
stantial quantities, and it enters or may reasonably be anticipated to enter
the environment in substantial quantities or there is or may be significant
or substantial human exposure to such substance or mixture.

(ii) there are insuflScient data and experience upon which the effects of
the manufacture, distribution in commerce, processing, use, or disposal
of such substance or mixture or any combination of such actions on health
or the environment can reasonably be determined or predicted, and

(iii) testing of such substance or mixture with respect to such effects is
necessary to develop such data ; and

(2) in the case of a mixture, the effects which the mixture's manuf.icture,
distribution in commerce, processing, use, or disposal or any combination of
such actions may have on health or the environment may not be reasonably
and more efl:icientlj determined or predicted by testing the chemical sub-
stances which comprise the mixture ;

558

the Administrator shall by rule require that testing be conducted on such sub-
stance or mixture to develop data with respect to the health and environmental
effects for which there is an insufficiency of data and experience and which are
relevant to a determination that the manufacture, distribution in commerce,
processing, use, or disposal of such substance or mixture or any combination of
such actions does or does not cause or significantly contribute to an unreasonable
risk to health or the environment.

(b)(1) Testing Requirement Rule. — A rule under subsection (a) requiring the
testing of a chemical substance or mixture shall include —

(A) identification of the substance or mixture for which testing is required.

(B) standards for the development of test data for such substance or mix-
ture, and

(C) a specification of the period (which period may not be unreasonable)
within which the persons required to conduct the testing shall submit to the
Administrator data developed in accordance with the standards referred to in
subparagraph (E).

In determining the standards and period to be included, pursuant to subpara-
graphs (B) and (C), in a rule under subsection (a), the Administrator shall
consider the relative costs of the various test protocols and methodologies which
may be required i ader the rule and the reasonably foreseeable availability of
facilities and personnel for performing testing under the rule. Such a rule may
require the submission of preliminary data during the period prescribed under
subparagraph (C).

(2) (A) The health and environmental effects for which standards for the
development of test data may be prescribed include carcinogenesis, mutagenesis,
teratogenesis, behavioral disorders, cumulative or synergistic effects, and any
other effect which may cause or significantly contribute to an unreasonable risk
to health or the environment, and the characteristics of chemical substances and
mixtures for which such standards may be prescribed include persistence, acute
toxicity, subacute toxicity, chronic toxicity, and any other characteristics which
may cause or significantly contribute to such a risk. The methodologies that may
be prescribed in such standards include epidemiology, serial, or hierarchical tests ;
in vitro tests ; and whole animal tests. Before prescribing epidemiology tests in
such standards, the Administrator shall consult with the Director of the National
Institute for Occupational Safety and Health.

(B) From time to time, but not less than once each twelve month, the Adminis-
trator shall review the adequacy of the standards for development of data
prescribed in rules under subsection (a) and shall, if necessary, institute proceed-
ings to make appropriate revisions of such standards.

(3) (A) A rule under subsection (a) respecting a chemical substance or mixture
shall require the persons described in subparagraph (B) to conduct tests and
submit data on such substance or mixture, except that the Administrator may
permit two or more of such persons to designate one such person or a qualified
third party to conduct such tests and submit such data on behalf of the persons
making the designation.

( B ) The following persons shall be required to conduct tests and submit data on
a chemical substance or mixture subject to a rule under subsection (a) :

(i) Each person who manufactures or intends to manufacture such sub-
stance or mixture if the Administrator makes a finding described in subsection
(a) (1) (A) (ii) or (a) (1) (B) (ii) with respect to the manufacture of such
substance or mixture.

(ii) Each person who processes or intends to process such substance or
mixture if the Administrator makes a finding described in subsection
(a) (1) ( A) (ii) or (a) (1) (B) (ii) with respect to the processing of such sub-
stance or mixture.

(iii) Each person who manufactures or processes or intends to manufacture
or process such substance or mixture for distribution in commerce if with
respect to the distribution in commerce of such substance or mixture the
Administrator makes a finding described in subsection (a) (1) (A) (ii) or
(a)(l)(B)(ii).

(iv) Each person who manufactures or processes or intends to manufacture
or process such substance of mixture if with respect to the disposal of such
substance or mixture the Administrator makes a finding described in sub-
section (a) (1) (A) (ii) or (a) (1) (B) (ii).

(v) Each person who manufactures or processes or intends to manufacture
or process such chemical substance or mixture for a use with respect to which

559

the Administrator makes a finding described in subsection (a) (1) (A) (ii) or
(a)(l)(B)(ii).

(4) A rule under subsection (a) requiring the testing of a chemical substance or
mixture shall expire at the end of the reimbursement period (as defined in subsec-
tion (c) (3) (B) ) applicable to test data for such substance or mixture, unless the
Administrator repeals the rule before such date.

(5) Rules issued under subsection (a) (and any amendment thereto or repeal
thereof) shall be promulgated pursuant to section 553 of title 5, United States
Code, except that in promulgating, amending, or repealing any such rule (A) the
Administrator shall give interested persons an opportunity for the oral presenta-
tion of data, views, or arguments, in addition to an opportunity to make written
submissions; and (B) a transcript shall be made of any oral presentation. The
Administrator may not promulgate a rule under subsection (a) respecting a
substance or mixture unless the Administrator makes and publishes with the
rule the findings described in paragraph (1) (A) or (1) (B) of such subsection
and, in the case of a rule respecting a mixture, the finding described in paragraph
(2) of such subsection.

(c) ExEAiPTioN. — (1) Any person required by a rule under subsection (a) to
conduct tests and submit data on a chemical substance or mixture may apply
to the Administrator (in such form and manner as the Administrator shall
prescribe) for an exemption from such requirement.

(2) If, upon receipt of an application under paragraph (1), the Administrator
determines that —

(A) the chemical substance or mixture (including any contaminant present
in such substance or mixture) with respect to which such application was
submitted is equivalent to a chemical substance or mixture for which data
has been submitted to the Administrator in accordance with a rule under
subsection (a) or for which data is being developed pursuant to such a rule,
and

(B) submission of data by the applicant on such substance or mixture
would be duplicative of data which has been submitted to the Administrator
in accordance with such rule or which is being developed pursuant to such
rule.

the Administrator shall exempt, in accordance with paragraph (3) or (4), the
applicant from conducting tests and submitting data on such substance or
mixture.

(3) (A) If the exemption of any person from the requirement to conduct tests
and submit test data on a chemical substance or mixture is granted on the basis
of the existence of previously submitted test data and if such exemption is
granted during the reimbursement period for such test data (as prescribed by
subparagraph (B)), then (unless such person and the persons referred to in
clauses (i) and (ii) agree on the amount and method of reimbursement) the
Administrator shall order the person granted the exemption to provide fair
and equitable reimbursement (in an amount determined under rules of the
Administrator ) —

(i) to the person who previously submitted such test data, for a portion
of the costs incurred by such person in complying with the requirement to
submit such data, and

(ii) to any other person who has been required under this subparagraph
to contribute with respect to such costs, for a portion of the amount such
person was required to contribute.

In promulgating rules for the determination of fair and equitable reimbursement
to the persons described in clauses (i) and (ii) for costs incurred with respect
to a chemical substance or mixture, the Administrator shall consider all relevant
factors, including the effect on the competitive position of the person required
to provide reimbursement in relation to the persons to be reimbursed and the
share of the market for such substance or mixture of the person required to
provide reimbursement in relation to the share of such market of the persons
to be reimbursed. An order under this subparagraph shall, for purposes) of ju-
dicial review, be considered final agency action.

(B) For purposes of subparagraph (A), the reimbursement period for any test
data for a chemical substance or mixture is a period —

(i) beginning on the date such date was submitted in accordance with a
rule promulgated under subsection (a), and

(ii) ending —

(I) five years after the date referred to in clause (i), or

I 560

(II) at the expiration bf a period which begins on the date referred
to in clause (i) and Jls' equal to the period which the Administrator
determines was necessary to develop such data, whichever is later.
(4) (A) If the exemption of any person from the requirement to conduct tests
and submit test (Jata on a chemical substance or mixture is granted on the basis
of the fact that' test data is being developed by one or more persons pursuant to
a rule promulgated under subsection ( a ) , then ( unless such person and the per-
sons referred to in clauses (i) and (ii) agree on the amount and method of re-
imbursement) the Administrator shall order the person granted the exemption
to provide fair and equitable reimbursement (in an amount determined imder
rules by the Administrator) —

(i) to each such person who is developing such test data, for a portion of
the costs incurred by each such person in complying with such rule, and

(ii) to any other person who has been required under this subparagraph
to contribute with respect to the costs of complying with such rule, for a
portion of the amount such person was required to contribute.

In promulgating rules for the determination of fair and equitable reimburse-
ment to the persons described in clauses (i) and (ii) for costs incurred with
respect to a chemical substance or mixture, the Administrator shall consider the
factors described in the second sentence of paragraph (3) (A). An order under
this subparagraph shall, for purposes of judicial review, be considered final
agency action.

(B) If an exemption is granted on the basis of the fact that one or more per-
sons are developing test data pursuant to a rule promulgated under subsection
(a) and if after such exemption is granted the Administrator determines that
no such person has compiled with such rule, the Administrator shall (i) after
providing written notice to the person who holds such exemption and an oppor-
tunity for a hearing, by order terminate such exemption, and (ii) notify in writ-
ing such person of the requirements of the rule with respect to which such ex-
emption was granted.

(d) Notice. — Upon the receipt of any test data pursuant to a rule under sub-
section (a), the Administrator shall, subject to section 14, promptly publish a
notice of the receipt of such data in the Federal Register. Each such notice shall
(1) identify the chemical substance or mixture for vv'hich data have been re-
ceived; (2) list the uses or intended uses of such substance or mixture and the
information required by the applicable standards for the development of test
data; and (3) describe the nature of the test data developed. Except as other-
wise provided in section 14, such data shall be made available by the Admin-
istrator for examination by any person.

(e) Priority List. — (1) (A) There is established a committee to make recom-
mendations to the Administrator respecting the chemical substances and mixtures
to which the Administrator should give priority consideration for the promul-
gation of a rule under subsection (a). In making such a recommendation with
respect to any chemical substance or mixture, the committee shall consider all
relevant factors, including —

(i) the quantities in which the substance or mixture is or will be
manufactured,

(ii) the quantities in which the substance or mixture enters the
environment,

(iii) the number of persons who will be exposed to the substance or mix-
ture in their places of employment and the duration of such exposure,

(iv) the extent of human exposure to the substance or mixture,

(v) the extent to which the substance or mixture is closely related to a
chemical substance or mixture which is known to cause or .significantly con-
tribute to an unreasonable risk to health or the environment,

(vi) the existence of data concerning the effects of the substance or mix-
ture on health or the environment,

(vii) the extent to which testing of the substance or mixture may result
in the development of data upon which the effects of the substance or mix-
ture on health or the environment can reasonably be determined or pre-
dicted, and

(viii) the reasonably foreseeable availability of facilities and personnel
for performing testing on the substance or mixture.

The recommendations of the committee shall be in the form of a list of chemical
substances and mixtures which shall be listed, either by individual substance or

561

mixture or by groups of substances or mixtures, in the order in which the com-
mittee determines the Administrator should take action under subsection (a)
with respect to the substances and mixtures.

(B) Not later than twelve months after the effective date of this Act, the
committee shall transmit to the Administrator the list required by subparagraph
(A) together with the reasons for the committee's inclusion of each chemical
substance or mixture on the lists. At leat>L every six months after the transmis-
sion to the Administrator of the list pursuant to the preceding sentence, the
committee shall make such revisions in the list as it determines to be necessary
and shall transmit them to the Administrator together with the committee's
reasons for the revisions. The Administrator shall make available to the public
the list transmitted by the committee, any revision by the committee in such list
(including the date on which such revision was transmitted to the Adminis-
trator), and the reasons of the committee for inclusion of a chemical substance
or mixture on the list and for any revision in the list. The Administrator shall
provide reasonable opportunity to any interested person to file with the Admin-
istrator written comments on the committee's list or any revision of the com-
mittee of such list and shall make such comments available to the public.

(C) The Administrator may promulgate a rule under subsection (a) with re-
spect to a chemical substance or mixture which is not coniained on a list pub-
lished under this subsection.

(2) (A) The committee established by paragraph (1) (A) shall consist of eight
members as follows :

(i) One member (or designee of the member) appointed from the Environ-
mental Protection Agency by the Administrator.

(ii) One member (or designee of the member) appointed by the Secretary
of Labor from officers of the Department of Labor engaged in the Secretary's
activities under the Occupational Safety and Health Act of 1970.

(iii) One member (or designee of the member) appointed from the Coun-
cil on Environmental Quality by the Chairman of the Council.

(iv) One member (or designee of the member) appointed from the Na-
tional Institute for Occupational Safety and Health by the Director of the
Institute.

(v) One member (or the designee of the member) appointed from the Na-
tional Institute of Environmental Health Sciences by the Director of the
Institute.

(vi) One member (or designee of the member) appointed from the Na-
tional Cancer Institute by the Director of the Institute.

(vii) One meinber (or designee of the member) appointed from the Na-
tional Science Foundation by the Director of the Foundation.

(viii) One member (or designee of the member) appointed from the De-
partment of Commerce by the Secretary of Commerce.

A member may designate an individual to serve on the member's behalf only
with the approval of the applicable appointing authority and only if the indi-
vidual is from the entity from which the member was appointed. A vacancy in
the committee shall be filed in the same manner in which the original appoint-
ment was made.

(B) (i) The term of office of a member of the committee is four years, except
that of the members- first appointed, four members shall have initial terms of
two years. Any member appointed to fill a vacancy occurring prior to the expi-
ration of the term for which the member's predecessor was appointed shall be
appointed only for the remainder of such term. If any member of the committee
leaves the office or entity from which the member was appointed, such member
may not continu as a member of the committee, and, for purposes of the pre-
ceding sentence, the member's position shall be considered as being vacant. A
member may serve after the expiration of the member's term of office until a
successor has taken office.

(ii) Initial appointments to the committee shall be made not later than the
sixtieth day after the effective date of this Act. Not later than the ninetieth day
after such date the members of the committee shall hold a meeting for the se-
lection of a chairman from among their number and to determine, by lot, the
four members who shall have initial terms of two years.

(C) The Administrator shall provide the committee such administrative sup-
port services as may be necessary for the committee to carry out its function
under this subsection.

562

AMENDMENT OFFERED BY MR. OTTINGER

Mr. Ottinger. Mr. Chairman, I offer an amendment.
The Clerk read as follows :

Amendment offered by Mr. Ottinger : Page 112, strike out the period in line
20 [Sec. 4(b)(2)(A)] and insert in lieu thereof a semicolon and the following:
"except that in prescribing tests the Administrator in his or her discretion shall
give preference to available tests which do not involve the use of animals if such
tests provide an adequate and accurate means for ascertaining the effect of a
chemical substance or mixture on humans and the environment."

Mr. Ottinger. Mr. Chairman, as I have stated previously, I strong-
ly support the Toxic Substances Control Act and I am proud to be one
of its cosponsors. I believe it needs to be improved, however, with
respect to use of nonanimal tests where they are adequate and accu-
rate. Therefore, I offer now the amendment which I previously offered
in committee and which was not adopted there, but I think it is a
tremendously important amendment because there is a history of
abuse of laboratory animals, and the use of animals where they are
not necessary, and it results in pain and cruelty to animals which is
totally unnecessary and which this amendment seeks to avoid.

The amendment requires the Administrator of the EPA to give
preference to tests which do not involve the use of animals but which
are found by him in his sole discretion to be accurate and adequate
for testing the toxicity of any chemicals to be tested.

In committee it was argued that this Avould subject the enforcement
o.f the act to possible litigation, but we did provide in the amendment
that the Administrator will have sole discretion in making testing de-
termination ; all he has to do is to consider the use of nonaminal tests
where they are available and make a determination that they are
adequate and accurate, and if he does make that determination he is to
give preference to those tests.

It seems to me that is a reasonable requirement which does not sub-
ject the implementation of the act to interference. Again the amend-
ment does not ban the use of animals, but it requires the Administrator
to use nonanimal tests where, in his sole discretion, he finds them to be
adequate and accurate.

The intent of the amendment is to require the Administrator to
consider tests which do not involve the use of animals, and thus prevent
unnecessary pain and suffering to which laboratory animals are often
subjected — and provide much cheaper and equally accurate testing in
many instances.

Two alternative testing methodologies presently exist and are used
.for testing possible carcinogenic substances. One test uses Salmonella
bacteria grown upon animal tissues instead of animals themselves. It
has been determined that the mutation of the bacteria catches between
80 to 90 percent of all cancer-causing chemicals. It has roughly the
same accuracy as is found in animal tests.

The other test, a new laboratory procedure, involves the growth of
mammal cancer cells or primary cells, and their exposure to a poten-
tially carcinogenic chemical. These nonanimal tests achieve striking
savings in time and dollars. To illustrate, the average animal test for
carcinogenic substances costs $150,000 and uses 400 animals over a
period averaging 3 years. The nonanimal Ames Salmonella test costs

563

$500 to $750 and can be completed in 2 days. The mammal cell tests I
referred to cost between $1,000 and $3,000 and take 3 to 6 weeks.

Nobel prize-winning biologist, Dr. Renato Dulbecco, in his prize-
winning lecture printed in Science Magazine of April 1976, said :

Identification by conventional (animal) tests is diflEicult because they are costly
and laborious, but they can now be replaced by the bacterial tests for promuta-
gens. Since these tests are easy and inexpensive, it should be possible to investi-
gate many normal constituents of the environment, and every compound before
it is offered to the public.

Similarly, Friends of the Earth conducted research which demon-
strates that these bacterial tests achieve the same 85 to 90 percent
accuracy as animal tests, at considerably less cost.

In addition, the Salem Research Institute of Germany recently pub-
lished a bibliography of the many already published experiments using
tissue culture to solve scientific problems. It published this compendium
in an effort to spur researchers into using nonanimal experiments. The
bibliography lists 286 selected tissue cultures used solely for cancer
research ; 626 such experiments for for pharmacological research.

Congress involved itself in protecting animals in laboratory experi-
mentation when it passed the Animal Welfare Act. We were respon-
sible for changing existing attitudes about the treatment of laboratory
animals, and these changes have been positive. We must continue what
we have started and I believe my amendment is one more step in theat
direction.

In their book entitled, "The Principles o.f Humane Experimental
Techniques," Russel and Rurch presented a formula for alleviating
suffering of laboratory animals, stating three criteria:

First. Redefinement of experimental techniques.

Second. Reduction of animals used.

Third. Replacement by less or nonsentient material.

My amendment is fashioned around this formula. It has the support
of the Society for Animal Protective Legislation, which sent a "Dear
Colleague" letter to all offices to support the amendment ; the Humane
Society of the United States; Defenders of Wildlife; Friends of the
Earth ; and Fund for Animals.

Mr. Chairman, at the appropriate time, I will ask unanimous con-
sent to have these statements of support put in the Record.

I just want to read briefly from the Fund for Animals :

Reducing the unnecessary use of animals in experimentation is a subject that is
of deep concern to the Fund for Animals and our 60,000 members across the
country. Congressman Ottinger's amendment is an excellent step in the right
direction which sets a valuable precedent in protecting animals without detract-
ing one iota from the public's right to be safeguarded from toxic substances.

Mr. Chairman, I urge my colleagues to support the amendment and
to support this important legislation.

Mr. WmTETirKST. Mr. Chairman, I rise in support o.f the amend-
ment offered by the gentleman from Xew Yoi'k which would prevent
the unnecessary use of animals in laboratory experiments. This amend-
ment would direct the Administrator to utilize available tests which do
nqt involve the use of animals and which provide an adequate and
accurate means of ascertaining the effects of chemical substances on
humans and the environment.

564

It is important to note that this amendment does not ban the use of
animal tests nor does it make it more difficult for the Administrator
to prescribe animal tests if he feels they are necessary. The amendment
simply requires the Administrator to consider alternate testing meth-
ods and directs him to use them when he finds they are adequate and
accurate.

Fortunately, technology now exists to test the impact of chemicals on
humans without the use of animals. These tests have the same 85 to 90
percent accuracy of animal tests and are actually much cheaper to
perform. Current tests using animals to determine the cancer-causing
potential of a chemical are expensive and lengthy, costing as much as
$150,000 a test for 400 animals and 3 years of work. One alternative
test using bacteria costs approximately $500 to $700 per test for a
2-day experiment. Another test involving lab-grown mammal cells
costs about $1,000 to $3,000 a test and takes 3 to 6 weeks. Consequently,
these newly developed tests are cheaper, easier, faster, and equally,
effective as the tests involving animals.

While it is true that we probably cannot eliminate the use o.f animals
altogether, I believe that we have a responsibility to limit the pain
and suffering of animals used in laboratory experiments to the maxi-
mum feasible extent. Since realistic and proven alternatives to the
use of animals exist, I feel the Congress should make clear its desire
to have these sound alternatives used whenever feasible. Once again, I
urge the adoption of this humane amendment offered by the gentle-
man from New York.

Mr. EcKHARDT. Mr. Chairman, I rise in opposition to the amend-
ment.

Now, Mr. Chairman, I recognize that it is always with some trepida-
tion that one should take the floor opposing a fund for animals or a
fund for anything else, because all these funds have behind them the
people with long memories and they have an intense interest in the
particular subject matter. Yet it seems to me inadvisable to direct the
Administrator with respect to the manner in which he determines a
danger to exist. In the first place, some of the dangers involve dangers
to the lower species themselves. For instance, in the case of PCB there
is danger to fish and in many instances new chemicals affect the envi-
ronment by affecting animals.

Now, it is true, of course, that the amendment only applies if tests
which do not involve the use of animals provide an adequate and ac-
curate means for ascertaining the effect o.f a chemical substance or
mixture on humans and the environment.

But actually, the Administrator usually does not come into the game
early enough to determine what kind of tests are to be used, whether
they are on animals or not on animals, because the Administrator
ordinarily merely requires testing. He does not detemine the precise
nature of the tests in most instances. He only prescribes the tests to be
applied to the extent necessary to assure that such data are reliable and
adequate, the manner in which such data are to be developed, the speci-
fication of any test protocol or methodology to be employed in the
development of such data, and such other requirements as are necessary
to provide such assurance.

Of course, this amendment only goes to the Administ^-ator's choice
of the use of tests. Ordinarily, the choice of use of tests is with the

565

person producing the chemical. He is conducting the tests, he is pre-
senting the data, and the Administrator may either accept the data
or may prescribe additional testing.

Now I suggest, Mr. Chairman, that we are ill advised to place in the
law itself this kind of directive. If we do, we are going to have people
meddling with the Administrator's process, with all good intention,
and thus holding up the ultimate result of the tests for inordinately
long periods of time.

Mr. Ottinger. On page 112, section 4(b)(2)(A), it says that the
Administrator can prescribe the standards for the development of test
data, and says specifically, starting on line 18, "The methodologies that
may be prescribed in such standards include * * *" and names the
various kinds o.f tests.

So that there is provision here for the Secretary to prescribe the
kinds of tests, and where there are nonanimal tests that are adequate,
he should prefer those. I do not think that does any mischief, and I
think it will help prevent some of the unnecessary carnage to animals
that does unfortunately occur in some hiboratories today.

Mr. EcKHARDT. It is true that he may prescribe the standards, and
he may ultimately prescribe the tests in certain instances, but it seems
to me that we would do great miscliief to permit anyone who wants to,
to come in and make an objection to the nature of these tests on the
grounds of some particular preference or some particular kind of test
or some particular prejudice against the use of a kind of testing.

For instance, concerning PCB's, I have a very interesting little docu-
ment here that was sent to me by the gentleman from Michigan (Mr.
Dingell). One of the statements is with reference to rhesus monkeys:

Rhesus monkeys exposed to dietary levels as low as 2.5 and 5.0 ppm of PCB
(lower than Lake Michigan fish) developed facial acne, subcutaneous edema and
loss of eyelashes.

Why not use those tests, and why should it be available for anyone
who has a particular love for rhesus monkeys, to come in and tr}^ to hold
up the testing and get some kind of a court determination as to whether
or not there is an adequate and accurate means of ascertaining whether
a poison would cause injury to people by some other means?

Mr. Ox-riNGER. I just want to say that tlie gentleman is playing
monkeyshines with my amendment.

Mr. Broyiiill. Mr. Chairman, just briefly, I want to say that I can
understand the gentleman's concern, but our concern, of course, is that
this amendment could do undue harm to testing of chemicals that
might be dangerous to the health of mankind and to the environment.
For these reasons, I oppose the amendment.

Mr. Koch. Mr. Chairman, I rise in support of the amendment. I
think it is a good one, and let me tell the Members why I think it is a
good amendment. I am not someone who is an antivivisectionist. I be-
lieve that there is appropriate experimentation on animals to be done.
That includes basic research ; that includes matters which would relate
to the welfare and the health of humankind as well as animals that are
not human. But, obviously there are limitations, and wherever it is
possible to use nonanimal substances for experimentation, surely that
is to be preferred instead of the use of animals.

I do not think anyone would want to quarrel with that. But even those
who would not want to quarrel with it are always reluctant, so to speak.

566

to enter the battle because in some way or other we think we are going
to limit the scope of experimentation and impose restraints on those
who "know better" than we do.

Mr. EcKHARDT. Who is to determine whether other experimentation
is adequate ? Is it going to be the court, or is it going to be a scientist ?

Mr. Koch. I will read the amendment. The amendment says :

. . . except that in prescribing tests the Administrator in his or her discretion
shall give preference to available tests which do not involve the use of animals if
such tests provide an adequate and accurate means for ascertaining the effect of
a chemical substance or mixture on humans and the environment.

It seems to me the amendment is very carefully drawn so as to allow
that discretion to the Administrator, who certainly should know
whether or not there are adequate substitutes.

Why would the gentleman not want to use a nonanimal substitute, if
one is available, in the discretion of the Administrator?

Mr. EcKHARDT. If the gentleman wdll yield to permit me to answer
the question, I would say he would have the discretion, clearly, if we
did not put this in the bill. I would hope he would lean in the direction
of humaneness.

Mr. Koch. Let me tell the gentleman why it does not always happen.

Mr. EcKHARDT. The thing is that this discretion, as I understand it,
is limited to a situation where there is not an adequate or an accurate
means for ascertaining the effects of a chemical substance.

Mr. Koch. Let me tell the gentleman a story, which happens to be
true and which happens to be current.

In the city of New York today, the Museum of Natural History is
engaging, quite properly, in experimentation with respect to basic re-
search. But there are those who believe — and I am one of them — that
the experimentation that they are undertaking with respect to cats is
unwarranted.

That is a layman's opinion, and I have asked the National Institutes
of Health for its opinion on it. I happen to have a lay opinion which
will not decide for me what I will ultimately do without getting a more
expert opinion, but it is a gut reaction.

I want to tell the Members what happened when I went to the Mu-
seum of Natural History, at the request of constituents who were dis-
tressed that the museum had received a grant from the Federal
Government, NIH, to engage in an experimentation on cats relating to
hyper- and hyposexuality. My constituents were told, based on the
grant application, that this museum was going to engage in the follow-
ing experimentation :

One, it was going to blind the cats. The fact is that they never did
that. I want to make that very clear. But it was one of the programs
that it was allowed to engage in under the grant that it received. And,
second, it was going to surgically affect the penises of kittens to ascer-
tain what effect that would have on sexuality, in addition to other
experimentation. So I went to the museum and I asked them to tell me
what it is that they were actually doing, and they asked me if I would
like to go in and see the cats in their cages, I said yes, and I went there,
and there were about 35 cats. They appeared w^ell treated, in the sense
that they were in clean cages, and they did not seem to be in any pain.
So I said to the doctor who was explaining what was happening,
"What do you do here? What is the purpose of this experiment?" And

567

she said, "Well, the purpose is to look at the effect of hyper- and
hyposexuality in cats. We find," said she, "that if you take a normal
male cat and you place that cat in a room with a female cat that is in
heat," said the professor, "the male cat would mount the female cat."
I said, "That sounds very reasonable to me."

Then she said, "Xow, if you take a cat, a male cat, and you put lesions
in its brain — "

I interrupted and asked, "'\"\niat are lesions?"

She said. "Well, you destroy part of the brain cells."

I asked, "What happens then?"

She said. "Well, if you take that male cat that has lesions in its brain
and you place it in a room with a female cat and a female rabbit, the
cat will mount the rabbit."

I said to her, "How does the rabbit feel about all this?"

There was no response.

Then I said to this professor, "Xow tell me, after you have taken a
deranged male cat with brain lesions and you place it in a room and you
find that it is going to mount a rabbit instead of a female cat, what have
you got?"

There was no response.

Then I ask, "How long, by the way, have you been doing this?"
She said, "$435,000."

I said, "How much has this cost the Government?"
She said. "^35,000."

Mr. Chairman, I tell this story, not because I am prepared to say
that experimentation on cats is wrong. I repeat I am not an anti-
vivisectionist. I am simply saying that there is a role here for lay
persons and an opportunity for people to be interested in what is tak-
ing place in this field, and where we can explore any of these basic
problems with nonanimal substitutes, if that is possible, then we
should. "Wliere it is not possible and if the project is scientifically
worthwhile — and I am not the one to suggest which projects are
worthwhile; I am going to leave that to the Administrator — then
obviously it should proceed.

All the amendment offered by the gentleman from New York (Mr.
Ottinger) does is it says that the Administrator in his discretion shall
give preference to nonanimal tests wherever those are available, and
that is on the basis of the facts as I have outlined them.

Mr. Chairman, on that basis would the gentleman not wish to sup-
port this Ottinger amendment?

Mr. EcKHARDT. Mr. Chairman, I think that the cat and rabbit situa-
tion may be most interesting, and it would bo more interesting if they
used a male rabbit and a female cat. However, it seems to me it is far
beside the point. This is an experiment for the sake of experimentation.

What we are talking about is experimentation with respect to a
poison. If it affects a cat or a rabbit, it w^ill probably, or may possibly,
affect a person.

Mr. Koch. Mr. Chairman, if the gentleman will bear with me, I
repeat if there is no other way, if there is no nonanimal substitute
available, the gentleman from New York (Mr. Ottinger) and I do not
disagree with the gentleman from Texas. Wiat we are saying is that
there ought to be consideration given to the use of nonanimal substi-
tutes when they are available.

568

Mr. Chairman, I think this is a very reasonable amendment, and I
urge the Committee to accept it.

Mr. Murphy of New York. Mr. Chairman, I regretfully oppose the
amendment offered by my colleague, the gentleman from New York
(Mr. Ottinger). The Ottinger amendment on its face directs the Ad-
ministrator in his or her discretion to give preference to tests which
do not involve the use of animals if such tests provide an adequate and
accurate means of ascertaining the health and the environmental
effects of a chemical.

This amendment could result in undermining the protection of
human health which can be achieved under this bill. The amend-
ment could result in EPA's not receiving the use of the most reliable
and effective means of determining the effect that a chemical might
have on a human being.

Although a nonanimal test may be adequate and accurate, a test
using animals may be more acceptable and more reliable. When the
objective is to protect human health, EPA should not be discouraged
from using the best means available of determining whether a chemi-
cal is safe.

The gentleman from New York (Mr. Ottinger) argues that the
amendment will result in reducing testing costs to manufacturers
because nonanimal tests are less expensive to perform. The bill
already fully protects manufacturers from being subjected to un-
necessarily expensive testing.

What it does do is that it permits a scientific evaluation by the
Environmental Protection Administrator as to whether to use photo-
chrom.atography or necessary animal testing, if that is required to
protect human health and human life.

Mr. Chairman, I think we should respect the various test protocols
and methodologies and the discretion of scientists within the tight
guidelines that we have in this bill.

Mr. Ottinger. Mr. Chairman, my good colleague, the gentleman
from Tennessee (Mr. Allen) points out that we could even insulate
this further from the courts if, before the word "discretion," we put
"sole," so that it would read: "The Administrator, in his sole dis-
cretion, shall give preference * *

Mr. Chairman, I have no objection to that.

Mr. Chairman, I ask unanimous consent that the word "sole" be
inserted before the word "discretion."

The Chairman. Is there objection to the request of the gentleman
from New York (Mr. Ottinger) ?

There was no objection.

The Chairman. The amendment is modified accordingly.

Mr. Murphy of New York. Mr. Chairman, if I might close, my
colleague, the gentleman from New York (Mr. Ottinger) and I have
supported legislation with respect to the slaughtering of animals in
laboratory animal testing, and our committee put strict Federal guide-
lines on animal testing in laboratories.

We also worked very closely on humane slaughtering in the slaugh-
ter liouses of America.

Mr. Chairman, with respect to the fact that certain societies have
written and have said that they support this amendment on the basis

569

of humane conditions for animals, I certainly can understand their
feelings; but I think we should underscore the philosophy here that
we are trying to protect humans as well as animals and that we should
use the most etfective and reliable methods. If animal testing is needed,
the discretion should be with the scientists at EPA to make that
determination.

Mr. McCoLLiSTER. Mr. Chairman, I wish to associate myself with
the remarks of the gentleman from New York (Mr. Murphy).

As I said, the sole basis for determining what tests are to be run
ought to be : What is best to preserve and protect human life ?

;Mr. Chairman, I think the amendment of tlie gentleman from New
York (Mr. Ottinger) provides additional criteria that might well in-
terfere with that objective.

Mr. Murphy of New York. Mr. Chairman, I urge my colleagues to
reject the Ottinger amendment.

The C II AIRMAN. The question is on the amendment offered by the
gentleman from New York (Mr. Ottinger) , as modified.

The question was taken; and on a division (demanded by Mr. Ot-
tinger) there were — ayes 14, noes 19.

Mr. Ottixger. Mr. Chairman, I demand a recorded vote, and pend-
ing that, I make the point of order that a quorum is not present.

The Chairman. Evidently a quorum is not present. Slembers will
record their presence by electronic device.

The call was taken by electronic device.

QUORUM CALL VACATED

The Chairman. One hundred Members have appeared. A quorum
of the Committee of the Whole is present. Pursuant to rule XXIII,
clause 2, further proceedings under the call shall be considered as
vacated.

The Committee will resume its business.

The Chairman. The pend'ng business is the demand of the gentle-
I man from New York (Mr. Ottinger) for a recorded vote.
A recorded vote was refused.
So the amendment, as modified, was rejected.

The Chairman. Are there further amendments to section 4? If not,
the Clerk will read.

The Clerk read as follows :

MANUFACTURING AND PROCESSING NOTICES

Sec. 5 (a) Notification for Manufacti re of New Chemical Substances. — On
and after the date on which the Administrator first publishes under section 8(b)
a list of chemical substances manufactured or processed in the United States, no
person may manufacture a new chemical substance unless (except as provided
|;in subsection (i) (relating to exemptions) ) such person —

(1) has, at least ninety days before such manufacture, submitted to the
Administrator, in accordance with subsection (f) (relating to notice con-
tent), a notice of such person's intention to manufacture such substance, and

(2) has complied with any applicable requirement of subsection (d) (re-
lating to submission of test data).

(b) Notification for the Manufacture or Processing of a Chemical Sub-
I stance for a Significant New Use. — (1) No person may manufacture or process
a chemical substance for a use which the Administrator has determined, in ac-
cordance with paragraph (2), is a significant new use of such substance unless
(except as provided in subsection (i) ) such person —

79-313 0 - 77 - 37

570

(A) has, at least ninety days before such manufacture or processing, sub-
mitted to the Administrator, in accordance with subsection (f), a notice of
Huch person s intention to manufacture or process such substance for such
use, and

(B) has complied with any applicable requirement of subsection (d).
(2) A determination by the Administrator that a new use of a chemical sub-
stance is a signihcant new use with respect to which notification is required under
paragraph (1) or subsection (c)(l)(ii) shall be made by a rule promulgated
after a consideration of all relevant factors, including —

(A) the projected volume of manufacturing and processing of such sub-
stance for such use,

( B ) the extent to which such use changes the type or form of exposure of
humans or the environment to such substance, and

(C) the extent to which such use increases the magnitude and duration
of exposure of humans or the environment to such substance.

The last sentence of section 19(c) (1) shall not aply to judicial review of any rule
promulgated under this paragraph.

(c) Notification for the Manufacture of Processing of Listed Chemical
Substances. — (1) (A) No person may manufacture a chemical substance —
(i) which is listed under paragraph (2), and

(,ii) wliich was a new cnemical substance at the time of publication of the
earliest proposed rule under paragraph (2) listing such substance,
unless (except as provided in suusectlon (i)) such person has, at least ninety
days before such manufacture, submitted to the Administrator, in accordance
with subsection (f ), a notice of such person s intention to manufacture such sub-
stance and has compUed with the requirement of subsection (d).

( B ) No person may manufacture or process a chemical substance, listed under
paragraph (2), for a use which the Administrator has determined, in accord-
ance with subsection (b) (2), is a significant new use of such substance unless
(except as provided in subsection (i) ) such person —

(i) has, at least ninety days before such manufacture or processing, sub-
mitted to the Administrator, in accordance with subsection (f), a notice of
such person's intention to manufacture or process such substance for such
use, and

( ii) has complied with the requirement of subsection (d) .

(2)(A)(i) Within twelve months after the effective date of this Act, the
Administrator shall, by rule, compile, and from time to time thereaj^ter revise, a
list of chemical substances the manufacture, processing, distribution in com-
merce, use, or disposal of which, or any combination of such actions respecting
which, the Administrator finds causes or significantly contributes to or may cause
or significantly contribute to an unreasonable risk to health or the environment.

(ii) In making a finding under clause (i) that the manufacture, processing,
distribution in commerce, use, or disposal of a chemical substance or any com-
bination of such actions causes or significantly contributes to or may cause or
significantly contribute to an unreasonable risk to health or the environment, the
Administrator shall consider all relevant factors, including —

(I) the effects of the chemical substance on health and the magnitude of
human exposure to it ; and

(II) the effects of the chemical substance on the environment and the
magnitude of environmental exposure to it.

(B) The Administrator shall, in prescribing a rule under subparagraph (A)
which lists any chemical substance, identify those uses, if any, which the Admin-
istrator determines, in accordance with subsection (b)(2), would constitute a
significant new use of such substance. The last sentence of section ll)(c) (1) shall
not apply to judicial review of any provision of a rule under subparagraph (A)
which provision is prescribed pursuant to this subparagraph.

(C) Any rule under subparagraph (A), and any amendment or repeal of such
a rule, shall be promulgated pursuant to the procedures specified in section 553
of title 5, United States Code, except that (i) the Administrator shall give in-
terested persons an opportunity for the oral presentation of data, views, or argu-
ments, in addition to an opportunity to make written submissions, and (ii) a
transcript shall be kept of any oral presentation. The Administrator may not
promulgate under subparagraph (A) a rule listing a chemical substance unless
the Administrator makes and publishes with the rule the finding described in
such subparagraph.

571

(d) Requirement Respecting Submission of Test Data. — (1) (A) If —

(i) a person is required by subsection (a), (b), or (c) to submit a notice
to the Administrator before beginning the manufacture or processing of a
chemical substance, and

(ii) such person is required to submit test data for such substance pur-
suant to a rule promulgated under section 4 before the submission of such
notice or such person has been granted an exemption under section 4(c)
from the requirement of such rule.

such person may not, before the expiration of the period prescribed by subpara-
graph (B), manufacture such substance if the person is subject to subsection
(a) or (c)(1)(A) or manufacture of process such substance for a significant
new use if the person is subject to subsection (b) or (c) (1) (B).
(B) The period referred to in subparagraph (A) is —

(i) in the case of a person required to submit te^t data pursuant to a rule
promulgated under section 4(a) a period of ninety days which begins on the
date on which such person submits to the Administrator such data in
accordance with such rule, and

(ii) in the case of a person who under section 4(c) is exempt from a re-
quirement to submit test data pursuant to a rule promulgated under section
4(a), a period of ninety days which begins on the date of the submission in
accordance with such rule of the test data the submission or the development
of which was the basis for the exemption.

(2) (A) If—

(i) a person is required by subsection (c) to submit a notice to the Ad-
ministrator before beginning the manufacture or processing of a chemical
substance, and

(ii) (I) a rule promulgated under section 4 before the submission of such
notice requiring the submission of test data for such substance does not
require such person to submit such data, or

(II) the Admini.^trator has not promulgated such a rule for such sub-
stance before the submission of such notice,
such person may not. before the expiration of the ninety-day peri(!d which begins
on the date such person submits to the Administrator data prescribed by sub-
paragraph (B), manufacture such substance if such person is subject to sub-
section (c)(1)(A) or manufacture or process such substance for a significant
new use if such person is subject to subsection (c) (1) (B).

(B) Data submitted pursuant to subparagraph (A) shall be data which the
person submitting the data believes show that —

(i) in the case of a substance for which notice is required under subsec-
tion (c) (1) (A), the manufacture, processing, distribution in commerce, use,
and disposal of the chemical substance or any combination of such actions
would not cause or significantly contribute to an unreasonable risk to health
or the environment, or

(ii) in the case of a chemical substance for which notice is required under
subsection (c) (1) (B), the intended significant new use of the chemical sub-
stance would not cause or significantly contribute to an unreasonable risk to
health or the environment.

(3) Data submitted under paragraph (1) or (2) shall be made available, sub-
ject to section 14, for examination by interested persons.

(e) Extension of Notice Period. — The Administrator may for good cause ex-
tend for one additional period of not to exceed ninety days the period, prescribed
by subsection (a), (b); (c), or (d), before which the manufacturing or processing
of a chemical substance subject to such subsection may begin. Subject to section
14, such an extension and the reasons therefor shall be published in the Federal
Register and shall constitute a final agency action subject to judicial review.

(f) Content of Notice; Publication in the Federal Register. — (1) The
notice required by subsections (a), (b), and (c) respecting a chemical substance
shall include —

(A) the name of the chemical substance;

(B) the chemical identity and molecular structure of the substance, insofar
as such are reasonably ascertainable ;

(D) a reasonable estimate of the amount of the substance to be manufac-
tured or processed and, insofar as reasonably ascertainable, a reasonable

572

estimate of the amount of the substance to be manufactured or processed
for each proposed category of use of the substance ;

('E) a description of the byproducts, if any, resulting from the manufac-
ture, processing, use, or disposal of the substance, insofar as such are rea-
sonably ascertainable; and

(F) any test aata in the possession or control of the person giving such
notice which are related to the effect on health or the environment of any
manufacture, processing, distribution in commerce, use, or disposal of the
substance or any article containing such substance.

Such a notice shall be made available, subject to section 14, for examination by

interested persons.

(2) Subject to section 14, not later than five days (excluding Saturday's, Sun-
days and legal holidays) after the date of the receipt of a notice under subsec-
tion (a), (b),or (c) or data under subsection (d) the Administrator shall publish
in the Federal Register a notice which —

(A) identifies the chemical substance for which notice or data has been
received ;

(B) lists the uses or intended uses of such substance; and

(C) in the case of the receipt of data under subsection (d), describes the
nature of tests performed on such substance and any data which was de-
veloped pursuant to subsection (d) or a rule under section 4.

Notice under this paragraph respecting a chemical substance shall identify the
chemical substance by generic class unless the Administrator determines that
more specific identification is required in the public interest.

(g) Regulation Pending Development of Information. — (1) (A) The district
courts of the United States shall, upon application of the Administrator made
through attorneys of the Environmental Protection Agency, have jurisdiction to
enjoin in accordance with subparagraph (B), the manufacture, processing, or
distribution in commerce of a chemical substance subject to a notification re-
quirement of subsection (a), (b), or (c) if the court finds that —

(i) information available to the Administrator is insuflScient to permit a
reasoned evaluation of the effects on health or the environment of the manu-
ture, processing, distribution in commerce, use, or disposal of such chemical
substance or any combination of such actions, and

(ii) in the absence of such information, the manufacture, processing, dis-
tribution in commerce, use, or disposal of such substance or an^ combination
of such actions may cause or significantly contribute to an unreasonable risk
to health or the environment.

(B) An injunction issued under subparagraph (A) with respect to a chemical
substance subject to a notification requirement under subsection (b) or (c) (1)
(B) respecting a significant new use of such substance shall apply only to the
manufacture, processing, or distribution in commerce, as the case may be, of the
substance for such use.

(i) upon the expiration of the five-day period beginning on the day after
the issuance of the injunction, if the Administrator does not within such
period publish the notice required by paragraph (2), or

(ii) if the Administrator publishes such notice within such period, upon
the completion or termination of the proceeding begun by publication of such
notice.

(2) (A) Within five days after the issuance of an injunction under paragraph
(1) with respect to a chemical substance, the Administrator shall publish, in ac-
cordance with section 553(b) of title 5, United States Code, a general notice of
proposed rulemaking to begin proceedings for the promulgation of a rule to apply
to such substance one or more of the requirements described in section 6(a) as is
necessary to adequately protect against the risk to health or the environment
found by the court under paragraph (1) (A) (ii).

(B ) Upon publication of such a notice the Administrator shall, as expeditiously
as possible, provide reasonable opportunity for a hearing (in accordance with
paragraphs (2) and (3) of section 6(c) ) on such proposed rule, and either adopt
such rule (as proposed or with modifications) or by notice published in the Fed-
eral Register terminate the pro<:'eeding for the promulgation of the rule. If such
a hearing is requested, the Administrator shall commence the hearing within

573

fifteen days from the date such request is made unless the Administrator and each
person making the request agree upon a later date for the hearing to begin, and
after the hearing is concluded the Administrator shall, within thirty days of the
conclusion of the hearing, either adopt such rule (as proposed or with modifica-
tions) or terminate the proceeding (as prescribed in the preceding sentence).

(3) After a rule promulgated under paragraph (2) has taken effect any person
may petition the Administrator to initiate a proceeding to amend or repeal such
rule. Within thirty days of the receipt of such a petition, the Administrator shall
by order either grant or deny the petition. If the Administrator grants such peti-
tion, the Administrator shall promptly initiate a proceeding for the amendment
or repeal, as the case may be, of such rule. Such a proceeding shall be conducted
in accordance with paragraphs (2) and (3) of section 6(c).

(h) Petition for Standards for the Development of Test Data. — A person
intending to manufacture or process a chemical substance for which notice is re-
quired under subsection (a), (b), or (c) and who is not required under a rule
under section 4 to conduct tests and submit data on such substance may petition
the Administrator to prescribe standards for the development of test data for
such substance. The Administrator shall either grant or deny any such petition
within sixty days of its receipt. If the petition is granted, the Administrator shall
prescribe such standards for such substance within seventy-five days of the date
the petition is granted. If the petition is denied, the Administrator shall publish
in the Federal Register the reasons for such denial.

(i) Exemption. — (1) The Administrator may, upon application (made in such
form and manner as the Administrator may prescribe) exempt any person from
the requirement of subsection (a), (b), (c), or (d) or of any combination of such
subsections to enable such person to manufacture or process a chemical substance
for test marketing purposes —

(A) upon a showing by such person satisfactory to the Administrator that
the manufacture, processing, distribution in commerce, use, and disposal of
such substance for such purposes would not cause or significantly contribute
to any unreasonable risk to health or the environment, and

(B) under such restrictions as the Administrator considers appropriate.
Within forty-five days of the receipt of an application under this paragraph

the Administrator shall either approve or deny such application.

(2) (A) The Administrator may upon application (made in such form and man-
ner as the Administrator may prescribe) exempt any person from the requirement
of subsection (d) (2) to submit data for a chemical substance. If, upon receipt
of an application under the preceding sentence, the Administrator determines
that—

(i) the chemical substance (including any contaminant present in such
substance) with respect to which such application was submitted is equivalent
to a chemical substance for which data has been submitted to the Adminis-
trator in accordance with subsection (d) (2), and

(ii) submission of data by the applicant on such substance would be dup-
licative of data which has been submitted to the Administrator in accord-
ance with such subsection,

the Administrator shall exempt the applicant from submitting such data on such
substance. No exemption granted under this subparagraph with respect to the
submission of data for a chemical substance may take effect before the beginning
of the reimbursement period applicable to such data.

(B) If the Administrator, under subparagraph (A), exempts any person from
submitting under subsection (d) (2) data for a chemical substance because of
the existence of previously submitted data and if such exemption is granted dur-
ing the reimbursement period for such data, then (unless such person and the
persons referred to in clauses (i) and (ii) agree on the amount and method of
reimbursement) the Administrator shall order the person granted the exemption
to provide fair and equitable reimbursement (in an amount determined under
rules of the Administrator) —

(i) to the person who previously submitted the data on which the ex-
emption was based, for a portion of the costs incurred by such person in
complying with the requirement under subsection (d) (2) to submit such
data, and

(ii) to any other person who has been required under this subparagraph
to contribute with respect to such costs, for a portion of the amount such
person was required to contribute.

574

In promulgating rules for the determination of fair and equitable reimbursement
to the persons described in clauses (i) and (ii) for costs incurred with respect
to a chemical substance, the Administrator shall consider all relevant factors,
including the effect on the competitive position of the person required to pro-
vide reimbursement in relation to the persons to be reimbursed and the share
of the market for such substance of the person required to provide reimburse-
ment in relation to the share of such market of the persons to be reimbursed. An
order under this subparagraph shall be considered final agency action, for
purposes of judicial review.

(C) For purjwses of this paragraph, the reimbursement period for any
previously submitted data for a chemical substance is a period —

(i) beginning on the date of the termination of the prohibition, imposed
under this section, on the manufacture or processing of such substance by
the person who submitted such data to the Administrator, and

(ii) ending —

(I) five years after the date referred to in clause (1), or

(II) at the expiration of a period which begins on the date referred
to in clause (i) and is equal to the period which the Administrator de-
termines was necessary to develop such data,

whichever is later.

(3) The requirements of subsections (a), (b), (c), and (d) do not apply
with respect to the manufacturing or processing of any chemical substance
which is manufactured or processed, or proposed to be manufactured or proc-
essed, only in small quantities (as defined by the Administrator by rule)
solely for —

( A ) scientific experimentation or analysis, or

(B) chemical research or analysis on such substance or another sub-
stance, including such research or analysis for the development of a product,

if all persons engaged in such experimentation, research, or analysis for a
manufacturer or processor are notified (in such form and manner as the Ad-
ministrator may prescribe) of any risk to health which the manufacturer or
processor has reason to believe may be associated with such chemical substance.

(4) (A) The requirements of subsections (a) and (e)(1)(A) do not apply
with respect to the manufacturing or processing of any chemical substance
which is the same as a listed chemical substance.

(B) For purposes of subparagraph (A), a chemical substance shall not be
considered as different from a listed chemical substance solely t>ecause —

(i) the proportion of the inert chemical substances which are present in
the listed chemical substance is different from the proportion of such sub-
stances present in the chemical substance being compared to the listed
chemical substance ; or

(ii) an inert listed chemical substance has been added to or deleted from
the chemical substance being compared.

(i) the term "inert chemical substance" means a chemical substance
which when combined with other chemical substances to produce another
chemical substance does not react chemically with such other chemical sub-
stances ; and

(ii) the term "listed chemical substance" means a chemical substance
included in the list compiled and published under section 8(b).

(5) The Administrator may, upon application, by rule exempt the manu-
facturer of any new chemical substance from all or part of the requirements
of this section if the Administrator determines that such chemical substance
will not cause or significantly contribute to an unreasonable risk to health or
the environment. A rule under this paragraph (and any substantive amendment
to, or repeal of, such a rule) shall be promulgated in accordance with para-
graphs (2) and (3) of section 6(e).

(j) Definition. — For purposes of this section, the terms "manufacture"
and "process" mean to manufacture or to process for commercial purposes.

Mr. Murphy of Xew York. . . . Mr. Chairman, I think it is im-
portant to point out to my colleagues that research chemicals are
exempted from the requirements of section 5. It has come to my*
attention that some people have interpreted this exemption as apply-
ing only to research chemicals ^Yhich are manufactured and used in-

575

house by a company. ^\liile the exemption does include such research
chemicals, it is not limited to them. If a chemical is manufactured by
one person in small quantities for use as a research chemical and sold
to another person to use for research purposes, then the exemption
covers such a chemical. In other words, one company can make chemi-
cals to be used for research by another company or by another person
and the exemption covers that chemical.

I would like to ask the authors of the legislation, the gentleman from
Texas (Mr. Eckhardt) and tlie gentleman from Xorth Carolina (Mr.
Broyhill), if that is their understanding of the exemption?

;Mr. EcsHARDT. ^Ir. Chairman, that is my understanding of the
exemption.

Mr. Broyhill. ^Ir. Chairman, I agree with the gentleman from
New York.

Mr. ^luRPHY of New York. Mr. Chairman, I would also like to
note that there are requirements in section 5 and elsewhere in the
bill that the Administrator publish information in the Federal
Register within a set number of days. The committee recognizes, of
of course, that the Administrator does not have control over the print-
ing schedule of the Federal Register. Thus, the requirement should
be construed as imposing on the Administrator the duty to submit the
information to the Federal Register for publication within the requi-
site time period.

One further point on section 5. A small manufacturer told me the
other day that he interpreted section 5 as permitting the Adminis-
trator to stop manufacture of a new chemical solely on the basis
that the new chemical would not be effective for its proposed use. Mr.
Chairman, I just want to clarify that this is totally untrue. Section 5
does not permit the Administrator to stop manufacture on the grounds
that a chemical will not be effective.

The CiiAiRMAx. Are there amendments to section 5? If not, the
Clerk will read.

The Clerk read as follows :

REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND MIXTURES

Sec. 6 (a) Scope oi Ri:gulatiox. — If the Administrator finds that there is a
reasonable basis to conclude that the manufacture, processing, distribution
in commerce, use, or disposal of a chemical substance or mixture or any com-
bination of such actions causes or significantly contributes to or will cause or
significantly contribute to an unreasonnble risk to health or the environment,
the Administrator shall by rule apply to such substance or mixture one or
more of the following requirements as is necessary to adequately protect against
such risk :

(1) A requirement prohibiting the manufacturing, processing, or distribution
in commerce of such substance or mixture or limiting the amount of such sub-
stance or mixture which may be manufactured processed or distributed in
commerce.

(2) A requirement —

(A) prohibiting the manufacture, processing or distribution in commerce
of such substance or mixture for (i) a particular use or (ii) a particular
use in a concentration in excess of a level specified by the Administrator in
the rule imposing the requirement or

(B) limiting the amount of such substance or mixture which may be
manufactured, processed, or distributed in commerce for (i) a particular
use or (ii) a particular use in a concentration in excess of a level specified
by the Administrator in the rule imposing the requirement.

576

(3) A requirement that such substance or mixture or any article containing
such substance or mixture be marked with or accompanied by clear and ade-
((uate warnings and instructions with respect to its use or disposal or with
respect to both. The form and content of such warnings and instructions shall
be prescribed by the Administrator.

(4) A requirement that manufacturers and processors of such substance or
mixture make and retain records of the processes used to manufacture or proc-
'2SS such substance or mixture,

(5) (A) A requirement regulating the manner or method of disposal of such
substance or mixture or article containing such substance or mixture by its
manufacturer or processor or any other person who uses it for commercial
purposes.

(B) A requirement under subparagraph (A) may not require any person
to take any action which would be in violation of any law of a State or
political subdivision, and shall require each person subject to it to notify each
State and political subdivision in which a required disposal may occur of such
requirement.

(6) If the rule imposes on a chemical substance or mixture a requirement
described in paragraph (1) or (2), a requirement directing the manufacturer,
processor, or distributor in commerce of such substance or mixture or article
containing such substance or mixture or directing any combination of such
person (A) to give notice of such risk to processors or distributors in com-
merce of such substance, mixture, or article, or to both, and, to the extent
reasonably ascertainable, to any other person in possession of or exposed to
such substance mixture, or article; (B) to give public notice of such risk; or
(C) to give both such notices.

A requirement imposed under this subsection shall be the least burdensome re-
quirement necessary to adequately protect against the risk with respect to which
the requirement was imposed and may be limited in application to specified
geographic areas.

(b) Protection Against Adulteration or Contamination of Substances
AND Mixtures. — If the Administrator has good cause to believe that a par-
ticular manufacturer or processor is manufacturing or processing a chemical
substance or mixture in a manner which unintentionally causes the chemical
substance or mixture to cause or significantly contribute to or to be likely to
cause or significantly contribute to an unreasonable risk to health or the
environment —

(1) the Administrator may by order require such manufacturer or
processor to submit a description of the relevant quality control procedures
followed in the manufacturing or processing of such chemical substance or
mixture; and

(2) if the Administrator determines after the issuance of an order de-
scribed in paragraph (1) —

(A) that such quality control procedures are inadequate to prevent
the chemical substance or mixture from causing or significantly con-
tributing to such risk, the Administrator may order the manufacturer
or processor to revise such quality control procedures to the extent
necessary to remedy such inadequacy ; or

(B) that the use of such quality control procedures has resulted in
the distribution in commerce of chemical substances or mixtures which
cause or significantly contribute to an unreasonable risk to health or
the environment, the Administrator may order the manufacture or
processor to (i) give notice of such risk to processors or distributors
in commerce of any such substance or mixture, or to both, and, to the
extent reasonably ascertainable to any other i)erson in possession of
or exposed to any such substance, (ii) to give public notice of such risk,
and (iii) to provide such replacement or repurchase of any such sub-
stance or mixture as is necessary to adequately protect health or the
environment.

A determination under subparagraph (A) or (B) of paragraph (2) shall be
made on the record after opportunity for hearing in accordance with section 554
of title 5, United States Code. The manufacturer or processor subject to a require-
ment to replace or repurchase a chemical substance or mixture may decide
whether to replace or repurchase the substance or mixture and shall take either
such action in the manner prescribed by the Administrator.

577

(c) Promulgation of Subsection (a) Rules. — (1) In promulgating any rule
under subsection (a) with respect to a chemical substance or mixture, the Ad-
ministrator shall consider all relevant factors and make findings with respect
to—

(A) the effects of such substance or mixture on health and the magnitude
of human exposure to such substance or mixture,

(B) the effects of such substance or mixture on the environment and the
magnitude of environmental exposure to such substance or mixture,

(C) the benefits of such substance or mixture for various uses and the
availability of other substances or mixtures for such uses, and

(D) the reasonably ascertainable economic consequences of such rule tak-
ing into account the impact on small business.

If the Administrator determines that a risk to health or the environment could
be eliminated or reduced to a sufficient extent by actions taken under another
Federal law (or laws) administered in whole or in part by the Administrator,
the Administrator may not promulgate a rule under subsection (a) to protect
against such risk unless the Administrator makes a finding that it is in the public
interest to protect against such risk under such rule taking into consideration all
aspects of the risk, the authorities under this Act and such other law (or laws)
to enforce actions taken under this Act or such law (or laws) to protect against
such risk, a comparison of the estimated costs of complying with actions taken
under such law (or laws), and the relative eflBcieucy of actions under this Act
and under such law (or laws). In the judicial review of a rule under subsection
(a) the last sentence of section 19(c) (1) shall not apply with respect to the
determinations and findings required to be made by this paragraph.

(2) (A) Rules under subsection (a) shall be promulgated pursuant to section
553 of title 5 of the United States Code ; except that in promulgating any such
rule (i) the Administrator shall give interested persons an opportunity for the
oral presentation of data, views, or arguments, in addition to an opportunity to
make written submissions; (ii) a transscript shall be kept of any oral presenta-
tion ; and (iii) during any such oral presentation, the Administrator shall include
an opportunity for cross-examination as provided in subparagraph (B). The
Administrator may not promulgate a rule under subsection (a) respecting a
chemical substance or mixture unless the Administrator makes and publishes
with the rule the finding described in such subsection.

(B) An interested person is entitled, if the Administrator determines that it is
necessary to resolve disputed issues of material fact, to conduct or have con-
ducted by the Administrator such cross-examination of persons as the Adminis-
trator determines (i) to be appropriate in view of any need for exj)edition, the
nature of the issues involved, and the number of participants and the nature of
thPix interests, and (ii) to be required for a full and true disclosure with respect
'0 such issues.

(C) (i) If the Administrator determines that a group of persons, each of whom
would but for this subparagraph be entitled to conduct (or have conducted)
cross-examination, has the same or similar interests in a proceeding, the Adminis-
trator may (I) conduct cross-examination on behalf of such group, or (II) re-
quire such group to designate a single representative of such interests for
purix)ses of conducting cross-examination in such proceeding and such representa-
tive shall, except as provided in clause (ii), conduct such cross-examination.
If such group cannot agree upon a single representative for such purposes, the
Administrator may limit the representation of such interests for such purposes.

(ii) When any person who is a member of a group with respect to which the
Administrator has made a determination under clause (i) is unable to agree
upon group representation with the other members of the group, then such per-
son shall not be denied under the authority of such clause the opportunity to
:onduct (or have c-onducted) cross-examination as to issues affecting the person's
particular interests if (I) the person satisfies the Administrator that the person
tias made a reasonable and good faith effort to reach agreement upon group
representation with the other members of the group and (II) the Administrator
determines that there are substantial and relevant issues which are not ade-
quately presented by the group representative.

(D) The Administrator may issue procedural rules for the conduct of any oral
presentation (including cross-examination) under this paragraph and may im-
pose such reasonable time limits on each person's oral presentations authorized
oj this paragraph as may be appropriate in view of any need for expedition, the

578

nature of the issues involved, and the number of participants and the nature of
their interests.

(E) In the judicial review of a rule under subsection (a) the last sentence of
section 19(c)(1) shall not apply to any determination of the Administrator
under this paragraph.

(3) (A) The Administrator may, pursuant to rules prescribed by it, provide
compensation for reasonable attorneys' fees, expert witness fees, and other costs
of participating in a rulemaking proceeding for the promulgation of a rule under
subsection (a) to any i)erson who represents an interest which will substantially
contribute to a fair determination of the issues to be resolved in the proceeding
taking into account the number and complexity of such issues and whether repre-
sentation of such interest will contribute to widespread public participation in
the proceeding and representation of a fair balance of interests for the resolution
of such issues if —

(i) the economic interest of such person is small in comparison to the costs
of effective participation in the proceeding by such person, or

(ii) such person demonstrates to the satisfaction of the Administrator
that such person does not have sufficient resources adequately to participate
in the proceeding in the absence of compensation under this subparagraph.

In determining whether compensation should be provided to a person under this
subparagraph and the amount of such compensation, the Administrator shall take
into account the financial burden which will be incurred by such person in par-
ticipating in the rulemaking proceeding.

(B) The aggregate amount of compensation paid under this paragraph in any
fiscal year to all persons who, in rulemaking proceedings in which they receive
compensation, are persons who either —

(i) would be regulated by the proposed rule, or

(ii) represent persons who would be so regulated, may not exceed 25 per
centum of the aggregate amount paid as compensation under this paragraph
to all persons in such fiscal year.

(4) Paragraphs (1), (2), and (3) of this subsection apply to the promulgation
of a rule repealing, or making a substantive amendment to, a rule promulgated
under subsection (a).

(d) Effective Date. — (1) The Administrator shall specify in any rule under
subsection (a) the date on which it shall take effect, which date shall be as
soon as feasible.

(2) (A) The Administrator may declare a proposed rule under subsection (a)
to be effective upon its publication in the Federal Register and until the effective
date of final action taken, in accordance with subparagraph (B), respecting
such rule if —

(i) the Administrator determines that —

(I) the manufacture, processing, distribution in commerce, use, or
disposal of the chemical substance or mixture subject to such proposed
rule or any combination of such activities is likely to result in an unrea-
sonable risk of serious or widespread harm to health or the environment
before such effective date ; and

(II) making such proposed rule so effective is necessary to protect!
the public interest ; and

(ii) in the case of a proposed rule to prohibit the manufacture, proc-
essing, or distribution of a chemical substance or mixture because of the
risk determined under clause (i) (I), a court has in an action under section 7
granted relief with respect to such risk associated with such substance or
mixture.

(B) If the Administrator makes a proposed rule effective upon its publication
in the Federal Register, the Administrator shall, as expeditiously as possible,
give interested persons prompt notice of such action, provide reasonable opi>or-
tunity, in accordance with paragraphs (2) and (3) of subsection (c), for a hear-
ing on such rule, and either affirm such rule (as proposed or with modifications)
or revoke it ; and if such a hearing is requested, the Administrator shall com-
mence the hearing within five days from the date such request is made unless
the Administrator and the person making the request agree upon a later date for
the hearing to begin, and after the hearing is concluded the Administrator shall,
within ten days of the conclusion of the hearing, either affirm such rule (as pro-
posed or with modifications) or revoke it.

579

AMENDMENT OFFERED BY MR. m'cOLLISTER

Mr. McCoLLiSTER. Mr. Chairman, I offer an amendment.
The Clerk read as follows :

Amendment offered by Mr. McCollister: Page 145, line 6 [Sec. 6(a)(5)(B)],
strike out "law of" and insert "law or requirement of or in effect for".

Mr. ^IcCoLLiSTER. Mr. Chairman, this is in the nature of a technical
or clarifying amendment. Under the bill, EPA can issue regulations
|concerning the manner and method of disposal. These regulations must
be in conformity with State law. This amendment would make clear
that when State regulations are in effect as required by Federal law,
such as the Clean Air Act or the proposed Solid Waste Disposal bill —
which would require State plans — the EPA disposal regulations would
also have to be in conformity with these requirements.
I I have discussed the amendment with the gentleman from New York
land the gentleman from Texas, and I believe that they are in agree-
iment on the clarifying intent of it.

Mr. MuRPiiY of New York. Mr. Chairman, the ranking minority
member has well stated the case, and I am happy to accept this
amendment.

The Chairman. The question is on the amendment offered by the
gentleman from Nebraska (Mr. McCollister).
The amendment was agreed to.

Mr. Hagedorn. Mr. Chairman, I have just two points I would like
to cover in a colloquy with the gentleman from New York (Mr.
Murphy).

On page 148 [Sec. 6(c)(1)] the Administrator is directed to con-
sider various factors before imposing sanctions permitted under sec-
tion (6) (a). Among these are (C) "the benefits of such substance or
mixture for various uses and the availability of other substances or
'mixtures for such uses . .

My question, is this intended to involve the Administrator ruling
upon the efficacy of a chemical for its intended purpose in any way?

Mr. Murphy of New York. No. The purpose of this language is to
be certain that the benefits of a substance are considered in any deter-
mination of whether a risk is lan unreasonable one.

Mr. Hagedorx. I thank the gentleman. I have a further question,
Mr. Chairman, for the gentleman from New York.

Section (6) (a) permits the Administrator to prohibit the manufac-
turing, processing or distribution of a chemical substance, or to limit
the amount which may be manufactured, processed or distributed in
commerce. My question is at this point, what does the term "limit"
contemplate? Does it mean quotas or levels of production, or how is
that word "limit" to be defined ?

Mr. IMt^rptt Y of New York. This would in no way mean quotas for
individuals. It would mean a limitation on the total manufactured
jvolume. Such limitations Avould have to apply equall}^ to all companies.

Mr. Hagedorx. Throu^rhout all chemical companies?

Mr. Murphy of New York. On that particular chemical.

Mr. Hagedorx. Would all companies be able to participate in the
manufacturing of that chemical, or would it be given possibly to
'ertain companies for that process ?

580

Mr. Murphy of New York. No, it would not be limited by com-
panies. It would be limited by volume.

Mr. EcKHARDT. I would think that the bill would envisage the
Administrator treating all manufacturers desiring to produce a lim-
ited quantity of a substance equitably, and in that way there would
have to be a division among companies.

^Ir. Hagedorn. Then there is adequate protection for the small
businessmen so that they will not be squeezed out ?

Mr. EcKHARDT. I would think not only should it be equitably
divided as among companies, but should he in terms of something
like equal quantities so as to give small producers something of an
advantage.

]Mr. Hagedorx. I thank the gentleman.

AMENDMENT OFFERED BY MR. DINGELL

Mr. DiNGELL. Mr. Chairman, I offer an amendment.
The Clerk read as follows :

Amendment offered by Mr. Dingell : Pag3 154, insert after line 21 [Sec 6] the

f ollow^ing :

(e) PoLYCHLOBiNATED BiPHENYLS. — (1) Within 6 months after the effective
date of this Act the Administrator shall initiate proceedings for the promulga-
tion of rules to —

(A) prescribe methods for the disposal of poly chlorinated biphenyls, and

(B) require polychlorinated biphenyls to be marked with clear and ade-
quate warnings and instructions with respect to their processing, distribu-
tion in commerce, use, or disposal or with respect to any combination of such
activities. Requirements prescribed by rules unaer this paragraph shall be
consistent with the requirements prescribed by or under paragraphs (2)
and (3).

(2) (A) Except as provided under subparagraph (B), effective one year after
the effective date of this Act no person may manufacture, proce^, or distribute
in commerce any polychlorinated biphenyl for any use other than a use in a
totally enclosed manner.

(B) The Administrator may by rule authorize the manufacture, processing,
or distribution in commerce (or any combination of such activities) of any
Ix)lychlorinated biphenyl for any use other than a use in a totally enclosed
manner if the Administrator tinds that such manufacture, processing, or dis-
tribution in commerce (or combination of such activities) will not cause or
significantly contribute to an unreasonable risk to health or the environment.

(C) For the purposes of this paragraph, the term "totally enclosed manner"
means any manner which will ensure that any leakage of a polychlorinated
biphenyl from its enclosure will be insignificant as determined by the Adminis-
trator by rule.

(3) (A) Except as provided in subparagraphs (B) and (C), effective two
vears after the effective date of this Act no person may manufacture any poly-
chlorinated biphenyl, and effective two and one-half years after such effective
date no person may process or distribute in commerce any polychlorinated
biphenyl.

(B) Any interested person may petition the Administrator for an exemption
from the requirements of subparagraph (A) for a particular use of a poly-
chlorinated biphenyl, and the Administrator may grant by rule such an exemp
tion if the Administrator determines that —

(i) the exemption is necessary for the protection of the health or environ-i
ment, and , . ,

(ii) good faith efforts have been made to develop a chemical substanc.
which mav be substituted for such polychlorinated biphenyl in such use
and which does not cause or significantly contribute to an unreasonable risk
to health or the environment.

An exemption granted under this subparagraph shall be subject to. such terms
and conditions as the Administrator may prescribe and shall be in effect for

such period (but not more than one year from the date it is granted) as the
Administrator may prescribe.

(C) Subparagraph (A) shall not apply to the distribution in commerce of any
article containing any polychlorinated biphenyl if such article was manufac-
tured before two and one half years after the effective date of this Act.

(4) Any rule under paragraph (1), (2)iB), or (3)(B) shall be promulgated
in accordance with paragraphs (2) and (3) of subsection (e).

Mr. DiNGELL. Mr. Chairman, this is a very simple amendment. My
colleagues have recently received "Dear Colleague*' letters from both
my friend and colleague, the gentleman from Maryland (Mr. Gude),
who joins me in the sponsorship of it, and from myself. It has the
support of all of the conservation organizations.

The amendment directs itself very clearly and very directly at one
substance, polychlorinated bi phenyls. Polychlorinated biphenyls have
been one of the biggest environmental problems that we have had
in the State of ^Michigan. And PCB's are also one of the biggest prob-
lems that most of the States in the Union have, in terms of long-term
degradation of the human environment and hazard to human health.
They are found in fish, they are found in the flesh of cattle, they are
.found in fowl, and they are found in the milk of the mothers of the
State of ^lichigan. They are a long-term hazard to human beings.
They are not biodegradable. They do not break down. They pei'sist.
They accumulate in the food chain. They are in the fish in the Hudson
River, they are in the fish in the Great Lakes, and they are one of the
reasons tliat the fish caught in the Great Lakes cannot be marketed
icommercially, in many instances.

' Mr. Chairman, the Toxic Substances Control Act is a good proposal
and it provides environmental protection, with urgently needed author-
ity. But there are no clear requirements in the bill mandating action
by EPA within a specified period of time to control or to regulate this
most persistent and this most hazardous of substances, the polychlori-
nated biphenyls.

The amendment requires the Environmental Protection Agency to
initiate proceedings within 6 months to prescribe methods for the dis-
posal of the polychlorinated biphenyls. There is no such requirement
in the bill. It requires them to be marked with warnings and with in-
structions for disposal, and it requires certain safeguards with regard
to rulemaking for the manufacture, processing and distributing in
icommerce of the polychlorinated biphenyls for any other use except in
a totally enclosed container. It also authorizes certain minor exempt-
tions winch may become necessary where the requirement is quite clear
that there is going to be no hazard to human health.
, Mr. Chairman, in a large number of other instances, such as the
Federal Water Pollution Control Act, the Administrator has author-
ity to control the discharge of PCB's, but it should be noted that this
authority, which was given in 1970, was not exercised by EPA until
•July 23, 1976, after this amendment had been brought forward.

We must ask : Why did EPA issue proposed regulations that would
prohibit discharges of this substance which will not become effective
for another 2 years ? Why do we single out PCB's ?

For many reasons. First of all, they are enormously persistent. Sec-
ond, they are enormously dangerous. Third, they accumulate in the
food chain. They flow upward toward human use. As I pointed out.

582

they are found not only in fish, the flesh of fowl and animals, but also
in the* milk of human mothers concentrating on the feeding of children.

Under section 6 of the bill the Administrator does not have
authority during the pendency of administrative decisionmaking to
effect the immediate prohibition of manufacture, processing or distri-
bution of any chemical substance. This amendment gives him that
authority, and I say that it is desperately needed.

Curiously enough, I spoke, on the way over here, to a representative
of one of the major manufacturers of PCB's, and he advised me his
company does not object to this amendment. His company felt that it
is a good one and it would help his company to be citizens. The amend-
ment does not call, I want my colleagues to know, for immediate pro-
hibition but, rather, a gradual phase out, to assure action within a
reasonable period of time.

As previously noted, the history of EPA is not one of vigorous and
quick action.

This amendment defines PCB's to be bad, hazardous, and danger-
ous, and it mandates a program for their gradual removal, beginning
with those uses which are outside of enclosed containers.

Mr. McCoLLiSTER. Mr. Chairman, the gentleman describes the risks
associated with PCB's. Is the gentleman aware of similar risks with
PBB's?

Mr. DixGELL. Mr. Chairman, I am fully aware of those risks, and it
would be my hope that some of my colleagues would offer an amend-
ment to apply this same principle to PBB's.

Mr. McCoLLTSTER. Mr. Chairman, I will suggest that we could go on
and on and on with these substances, but that is not what this whole
legislation is about.

Mr. DixGELL. Mr. Chairman, if the gentleman wishe« to offer an
amendment to add PBB's, I will support it, because I am fully aware
of the perils of PBB's. If the gentleman wants to offer such an amend-
ment, I would be happy to support it. I think it might be a meritorious
amendment.

I would point out that we have a long history of PCB's. We know
of their perils, we know that PCB's are not biodegradable, we know
that they accumulate in the food chain, we know they are a hazard,
we knew they are universal, and we know that they actually have a
longer life than many radioactive substances. For those reasons, I urge
my colleagues to support the amendment.

I would point out that PCB's have caused a major cessation of com-
mercial fishinor activities in all the Great Lakes. A $95 million-a-year
industry could be shut down because of PCB's. A similar situation
has occurred in the rivers of Xew York, in the rivers of New England,
in the Mississippi River, the Missouri, the Ohio, the Columbia River
system, and in the Sacramento River. It even extends to the Gulf
Stream and to the Yukon in Alaska.

Mr. Ottixger. Mr. Chairman, I rise in support of the gentleman's
amendment.

All of the commerecial fishing activities have been very substan-
tially damaged in the Hudson River. Even fishing has been barred
because of the presence of PCB's in the Hudson River at the present
tim^ and that has caused tremendous damage to the commercial fish-

583

mg industry in Xew York. I think the gentlemen's amendment is a
v'ery important one.

Mr. DiXGELL. Mr. Chairman, I thank my good friend, the gentleman
from Xew York.

There is no assurance unless this amendment is adopted that PCB's
will be attacked. Section 6 does not give immediate power to the EPA
to get PCB's off the market and out of places where they are a hazard
bo humankind.

• Mr. Chairman, I urge my colleagues to support the amendment
which my colleague and friend, the gentleman from Maryland (Mr.
Grude) , and I have offered to the House at this time.

Mr. McCoLLiSTER. ^Mr. Chairman, I rise in opposition to the amend-
ment.

^ Mr. Chairman. I oppose the amendments for some of the reasons
that our brief colloquy suggested.

'■ This legislation that we are considering gives the EPA general
authority to regulate hazardous chemicals. I think consequently it is
improper in the context of this legishition to attempt to regulate a
specific chemical in a specific fashion. Further, there is no reason why
PCB's should be treated in this fashion and other known environmen-
tal hazards such as perhaps vinyl chloride or asbestos, for example,
'should be excluded from the same specific treatment.

Second, the amendment would restrict EPA to an inflexible sched-
ule. Under the provisions of the bill EPA could do all of the things
that the gentleman from Michigan (Mr. Dingell) would like to do.
However, EPA has the authority to establish its own timetable for
regulating PCB's. Indeed, the EPA may feel that the 21/^ years the
gentleman from Michigan (Mr. Dingell) suggests is too long and that
more immediate action might be necessary. Tlie Dingell amendment
could in this case actually slow down the regulatory process.

Mr. Russell Train, the Administrator of EPA, has indicated in a
press report that I have seen that he would prefer that the bill did not
set specific deadlines for phasing out PCB's.

The third reason why I am opposed to the amendment offered by
the gentleman from Michigan (Mr. Dingell) is that by mandating a
complete phasing out of PCB's in 21^ years the amendment is attempt-
ing to legislate technology. Although substitutes with the necessary
alectrical characteristics are now being developed, the perfect substi-
tute for PCB's in closed electrical systems does not yet exist.

Banning the use of PCB's in closed electrical systems before a suit-
lable substitute has been developed may result in a cure which is worse
than the problem. For example, PCB's are used in capacitors and
transformers not only because of their electrical characteristics, but
also because the substance is nonflammable. Therefore, any substitute
for PCB's must also have the same fire-resistant properties. Such a
substitute has not yet been developed.

Mr. Dingell. Mr. Chairman, I would like to point out to my good
friend, the gentleman from Nebraska (Mr. McCollister) , that, first
of all, the phaseout is required to take place over a period of time.
Second of all, there is provision for an exemption in the amendment
which we have offered to allow year-by-year extension where no sub-
stitute is available.

584

Mr. McCoLLiSTER. Fourth, Mr. Chairman, there is no need for the
amendment since the EPA has indicated a willingness to proceed
expeditiously in this area. For example, in April of this year, EPA
published its "Recommended Procedures for Disposal,'' applicable to
wastes containing PCB s. PCB's are found in many small appliances
as well as in fluorescent light bulbs, and, consequently, disposal of
these items must be closely checked. Further, on July 23 of this year,
EPA issued proposed effluent standards for PCB's affecting all PCB
manufacturers and transformer and capacitor manufacturers. These
standards were issued pursuant to a consent agreement entered into
between EPA and the National Resource Defense Council.

Fifth and finally, Mr. Chairman, coverage under the amendment
is unclear. It would appear, although it is not certain, that the Dingell
amendment would not require that existing equipment containing
PCB's must be discarded. That existing equipment could be used for
the rest of the useful life should be made clear. Further, it would be
helpful if the gentleman from Michigan (Mr. Dingell) would state
that the amendment is not intended to curtail the resale or repair of
existing equipment.

For all these reasons, Mr. Chairman, I oppose the amendment of the
gentleman from Michigan (Mr. Dingell).

Mr. GuDE. Mr. Chairman, I rise in support of the amendment.

Mr. Chairman, this legislation is certainly meritorious and goes a
long way to deal with toxic substances in our environment. But, in the
case of PCB's, however, we have a problem that is a little different
from some of the ones that have been discussed on the floor.

There has been concern about the act injuring small business; but
our amendment does not affect small business except in the handling
of articles that have PCB's in them; in such cases there i§,a provision
whereby sm^all firms would be protected.

Mr. Chairman, there is only one company, which is a large manu-
facturer of PCB's in this country; they have already indicated to EPA
their interest in phasing out this material.

But, the most important thing about PCB's, as opposed to other
materials which are unknown quantities as far as danger is concerned,
is that we have identified a mad dog — a known bad actor in the case
of PCB. There is no doubt about its toxicity and danger in the environ-
ment. It has caused millions of dollars worth of damage in the United
States ; the time has arrived to get rid of it.

Mr. Chairman, State governments all across the country, not just
the Federal Government, have been concerned.

The States of New Jersey, Georgia, California, Washington, Texas,
Michigan, and my own State of Maryland favor this amendment and
wish to see the PCB's phased out.

As my colleague, the gentleman from Michigan (Mr. Dingell), has
pointed out, this amendment does not specify replacement of PCB's
in existing equipment or the equipment itself. Xew language that we
have added to the amendment makes it clear that the distribution as
well as the resale of PCB-containing equipment manufactured prior
to the ban, is not prohibited. This would apply to such everyday prod-
ucts as air conditioners.

585

Also, the amendment does have flexibility in it in that it includes
exemptions in certain cases if acceptable substitutes are not yet
developed.

For example, an electric company must show that continued use of
PCB's in transformers is necessary to guarantee safety from fire and
that they are making a good faith research effort to find substitutes.

Mr. Chairman, the amendment which has been drawn by the gentle-
man from Michigan and myself is well thought out.

It provides a timetable which will speedily eliminate the introduc-
tion of additional PCB's into the environment without damage to the
citizens and industry.

The Japanese people suffered a terrible tragedy from PCB poison-
ing; probably because of the centralized system of their government
they were able to move swiftly and eliminate this product from the
industrial and business technology of their country. Because of the
need for conformance of State regulations and requirements that would
provide for PCB substitutes the amendment my colleague, the gentle-
man from Michigan (Mr. Dingell), and I have offered will give a
strong impetus to the phasing out of the manufacture and distribution
of all PCB's.

This is a bad problem; it has already caused millions of dollars of
damages to the fisheries across the Nation. It is a problem that has been
identified by the State and Federal governments — let's act before we
have another environmental tragedy.

Mr. Chairman, I urge the adoption of the amendment.

Mr. EcKiiARDT. Mr. Chairman. I rise in opposition to the amendment.

Mr. Chairman, we have today in the legislation of the United States
four environmental and safety haws of major significance. We have the
Clean Air Act, tl^e Water Pollution Control Act. We have OSHA and
we have the Product Safety Act. This would be a fifth major piece of
legislation to protect the environment and the safety of the people. But
we are now just initiating a new act in an extremely important field
and we have not ordinarily, when we enacted legislation in any of
these fields, attemnted to address; specifically particular scientific ques-
tions. I think we have done well not to do so here.

Why should we, in enaf^ting this act, move specifically to deal with
PCB'S and not PBB's? We are not attempting to, and of course it is
a little too late to deal with vinyl chlorides by" preventing their entry
into the market. Xor are we attempting to regulate O^IB's, a pernicious
and persistent toxin that get in the legislative environment. I do not
think we should try to antici])ate each specific danger to the environ-
ment. If we do, we will overly encumber this bill.

Suppose it is discovered that in the entire range of dangerous sub-
stances some type of pattern of removing them from the marketplace
or limiting their use to control the environment is desirable ; then the
agencv may set up regulations in which the treatment of PCB's is
specifically dealt with in a different way than the present pattern of
control which may ultimately seem tlie most desirable. Why carve out
one chemical to treat in this inanner ? There are many other cliemtca Is
that presently pose potential danger. I think that we would be well
advised to let the ao^encv chart its course in the same manner that we

586

have let other agencies with like authority chart their courses, and not
foist upon a preconceived manner of control before we find whether
they will in due course address the question.

As has been pointed out before, the EPA has already indicated
its willingness to move in this direction.

Mr. DixGELL. Mr. Chairman, I would like to ask the gentleman
some questions. I would like to ask the gentleman whether under
section 6 of the bill the Administrator has not the authority during the
pendency of the administrative law making the function of immedi-
ately prohibiting the manufacturing or processing of chemical sub-
stances such as PCB's ?

Mr. EcKHARDT. When he goes through the procedures provided by
section 6, he has, yes.

Mr. DiNGELL. But he may not do it during the pendency, even though
the peril is as great as it is in PCB's?

Mr. EcKHARDT. No. He is required to give due process to the person
against whom the rule may be issued, and I think that is most desirable.

Mr. DixGELL. The answer to the question is he may not during the
pendency of the rulemaking rule out substances like PCB's?

Mr. EcKHARDT. Wait just 1 minute. He can use the imminent hazard
technique of stopping PCB's if he can in fact prove they are hazardous.

Mr. DiNGELL. But in that, that action is subject to long and sustained
court review which may drag out over a period of years.

Mr. EcKHARDT. Not unless a higher court actually stays the action
of a lower court. One can easily get the same instant relief that one
can get in other cases involving a court's peremptory authority to
enjoin.

Mr. DiNGELL. The gentleman is very carefully and I think very
prudently, and in a very lawyer-like fashion, pointing out that the
failure to rule this out would be dependent upon the prudence of a
higher court upon appeal. That is, there is not immediate power in the
administrator to move them out except subject to court review ; am I
correct in that statement ?

Mr. EcKHARDT. Except subject to court action. I think that the only
way that the agency can finally outlaw PCB's or limit them under
section 6 is after a rather complete due process-oriented type of
hearing.

But if during the pendency of the rulemaking, the continued release
of PCB's into the environment would constitute an imminent hazard,
the agency may go into court and by proving that such is the case,
may get an injunction which would immediately stop the complained
of activity.

Mr. DiNGELL. This is a matter, though, which is time consuming
and which is subject to judicial review and which could take a substan-
tial amount of time.

Mr. EcKHARDT. It is not time consuming from the time the action is
brought in court initil the time the court has the power to act; it may
be time consuming in the long run, but that may work against either
the manufacturer of the PCB's or against the public. The question has
to be decided by the court as to whether or not a preliminary injunc-
tion will be granted, or whether action will be upheld pending the
ultimate ruling.

587

Mr. DixGELL. The gentleman is a very able lawyer and valuable
Member of the House. The hard fact of the matter is that the com-
mittee bill, as opposed to the amendment offered by my friend and
colleague, the gentleman from Maryland (Mr. Gude) and me, re-
garding PCB's which are a proven hazard — this would much more
quickly and expenditiously remove them from the environment than
would be the situation under the committee bill.

Mr. EcKiiARDT. That is right. Of course, we can legislatively do any-
thing to anybody as long as we comply with due process of law. I sup-
pose that is done, but I think judicial process would be preferable in
this case.

Mr. Dext. ^Ir. Chairman, I am not going to take time on the PCB's
except to give the Members a related situation which I think many
Members — most Members of this Congress— have heard something
about.

If this type of legislation had been brought before this House 3
years ago, there would probably be a group of citizens Avho would have
some hope of living out their lives in an orderly and normal fashion.
Kepone was a chemical. It was known to be a dangerous chemical. It
was known to be the kind of chemical that could not be restrained in
any given course. It could not be held within any confined area. Yet
with warning after warning and appeal after appeal to various State,
local, and Federal Government inspection agencies, nothing was done.
It took two committees of this House, the gentleman from New
Jersey's, Mr. Daniels, and my own, to spend a weekend after a great
deal of research at the homesite of the Kepone manufacturer. To the
best of our knowledge, this entire family of workers — and I mean
family by going into not only the worker himself but the family and
the children — was affected. We saw before us children whose eyes
flickered constantly. The workers were told that they had some sort
of Parkinson's disease.

However, they could not get any evidence in the town from any of
the medical authorities or from the Federal or State or local inspec-
tion officials that it was the kind of toxic material which ought to be
investigated thoroughly and on which work ought to be stopped im-
mediately and that they should not be permitted to continue.

There is no hope for any of the workers who worked in that plant,
as far as we know. The people have had to go to the extreme precau-
tion of completely burning down the plant and cleaning that up. Now,
there is a suit pending and a plea and an admission of guilt on the part
of one of the officers of the company, which may result in hundreds of
millions of dollars of damages — but these damages w^ll do no good for
the sick people.

This kind of action should have been taken whenever there was any
reasonable cause to expect that by stopping and investigating we could
avoid that kind of disaster. And it is a disaster. The folks today are
nothing but living dead.

Mr. Leggett. Mr. Chairman, I rise in support of the amendment. As
chairman of the Subcommittee on Fisheries and Wildlife Conserva-
tion and the Environment, this issue has been of particular concern
to our Members. The subcommittee held 3 days of oversight hearings
in January 1976, to examine the impact of jpolychlorinated biphen-

588

yls — PCB's — and similar toxic substances on fisheries and wildlife
resources. Witnesses from the administration and from the industry
presented us with startling evidence of the critical levels of PCB resi-
dues found in samples of birds and fresh water fish all over the United
States. Consequently, the survival of some threatened and endangered
species is involved. PCB contamination appears to severely reduce the
reproductive success of the bald eagle, along with other waterfowl and
mammals, according to the U.S. Fish and Wildlife Service.

The adverse and far-reaching effects of PCB's are most vividly
demonstrated in the Great Lakes region. In the past decade, Canada
and the United States have invested solidly in restoring the fishery
resources of the Great Lakes, and their programs — such as trout res-
toration— are threatened by PCB levels in Great Lakes fish which now
exceed the permissible amount established by the FDA. Many species
are close to being considered unmarketable, raising the potential
spectre of the closing of the $95 million commercial fishing industry
and the $300 million sport fishing industry of the Great Lakes. This
is no exaggerated speculation, as Lake Michigan and the Hudson
River have already been closed for given periods to commercial fishing
becai;se of high levels of PCB's.

PC B's are difficult to regulate as they are used in widely different
industries for a variety of uses. They contaminate our rivers and
waterways through the dumping of waste materials — such as plastic
bottles, ink, papers — containing toxic substances. Although the only
American manufacturer of PCB's Monsanto, has voluntarily restricted
its production to enclosed uses — such as in electrical transformers —
such industrial self-regulation and existing laws have failed to pre-
vent the seepage of 10 million pounds of PCB's into the environment,
and even greater quantities through sewage treatment systems and
imported products. In view of the fact that PCB's cannot be removed
from the environment and are not readily biodegradable, it will take
years before our contaminated Avaterways will be ready again for com-
mercial and recreational fishing if PCB's were eliminated now.

The flexibility of the Dingell-Gude amendment is shown by its
exemption provisions, which recognize that some uses of PCB's out-
weigh safety considerations. Feasibilit}' of PCB elimination has been
shown by the example of Japan's almost complete PCB ban and its
successful use of substitutes.

It is significant that the executive department's involved voice
strong support of this amendment. The U.S. Fish and Wildlife Service
supports a complete ban of PCB's. Russell Train, Administrator of
EPA, told us :

So far as I am concerned, there is absolutely no disagreement whatsoever that
PCB's should be eliminated, all uses should be gotten rid of just as rapidly as
we can."

I stress today just the sense of emergency that Russell Train did in
January. If PCB's were abolished tomorrow, it would be 100 to 200
years before they would allow a decision on PCB's to undergo the re-
view process of H.R. 14082, PCB's will continue to seep into the en-
vironment, endangering human health, our wildlife resources, and our
freshwater fishing industries for several years. The Dingell-Gude
amendment will give us a program immediately, setting the mandatory
deadline for a phase-out of PCB's.

589

I trust that my colleagues will recognize the profound detrimental
eliects this one toxic substance has on our enviromnent, and will real-
ize the need to clarify the phaseout of PCB's as a priority under the
Toxic Substances Act of 1976, as this amendment would do.

There is no partisan division in the subcommittee with respect to
the urgency and importance of solving this PCB problem. Therefore,
I would urge that the House support this amendment.

Mr. Ottixger. Mr. Chairman, I have been told, and I would like
to have the gentleman confirm it, that in many places in the United
States, mothers' milk is now so contaminated with PCB's that it
would not be allowed to be shipped in interstate commerce if it were
in any other container. Is that correct ?

Mr. Leggett. I have not heard that, but if the gentleman makes
that assertion I am sure it is worthy of review.

Mr. GuDE. ^Ir. Chairman, I want to commend the gentleman for
his remarks, particularly in drawing attention to the widespread
dispersal of this contaminate in our environment.

To further illustrate, Mr. Chairman, I would like to just quote
from a telegram from the Georgia Game and Fish Division:

Serious poly chlorinated biphenyls (PCB) contamination problem just en-
countered at Lake Hartwell with harsh impact affecting sport fishermen and
businesses dependent thereon. PCB ubiquitous in the environment and posing
serious threat to human health and all living natural resources.

Mr. Chairman, I think we have ample testimony that we have a
mad dog, in the form of PCB, on our hands. We must pen him up and
I urge support of this amendment.

Mr. Dellums. Mr. Chairman, I would like to associate myself with
the gentleman's remarks.

. ^Ir. Chairman, I also would like to point out, I think the distin-
guished gentleman from Pennsylvania (Mr. Dent) made a very tell-
ing and important statement, that is, where there is reasonable docu-
mentation as to the danger of a snbetanro to life in ireneral and to
human life specifically, there is no obligation more important than the
human responsibility to protect that life.

It would seem to me almost incredible as I have sat here quietly
and patiently listening to the debate for any person to raise the legal
argument or the political argument or the economic argument that
in any way transcends the important responsibility we have to protect
human life under conditions which are injurious or a danger to human
life and we have a responsibility, clinical and moral, to protect the
citizens.

Mr. Leggett. Mr. Chairman, the gentleman is exactly correct.

Mr. Murphy of Xew York. Mr. Chairman, during the debate in
the committee, I supported this amendment. T supported it because
polvchlorinated biphenyls have been proven today to be a highly toxic
and persistent chemical. It causes skin ailments, liver ailments, and
undersized infants. In laboratory animals they have produced skin
cancer and genetic effects.

True, the substances are necessary at the present time for use in
capacitors and transformers. We have heard the debate on what the
Japanese have Hone and what they have been forced to do because of
the effects on their environment.

This amendment seems reasonable. It gives at least 2 years to the
industn^ to come up with substances other than PCB's. I think 21/^

590

years is certainly a reasonable compromise and warning to the indus-
try. The EPA Administrator is given the flexibility to extend, if
necessary, that period of time. PCli s are a highly persistent and toxic
chemical. They Imxe caused great damage to the Great Lakes, and
irreparable damage in the Pludson River. The State of New York
estimates it will take over $20 million to correct the damage at the
present time to bring back the fisheries areas that have been so harm-
fully affected.

Mr. Chairman, I hope we adopt this amendment.

The Chairman. The question is on the amendment offered by the
gentleman from Michigan (Mr. Dingell).

The amendment was agreed to.

The Chairmax. Are there further nmei-idments to section 6?

Mr. Ottixger. Mr. Chairman, very briefly, I ask the chairman of
the committee, since my amendment was not adopted which would
require preference be siven to nonanimal tests, it does appear that
that is the intent of the committee in the report on page 19 [Sec.
4(b)(2)(A)] which reads as follows:

However, the Committee does not intend that the Administrator needlessly
require whole animal tests. The Administrator should consider alternative test
methods. With the development of reliable non-animal tests for predicting the
long-term effects of chemicals on health, the need for animal test data to deter-
mine if a substance or mixture causes or significantly contributes to an unrea-
sonable risk will diminish.

The report also says that the committee opposes the amendment
only so as not to put a legal restriction on the Administrator, though
it agrees with the thrust of the amendment that nonanimal tests should
be preferred where adequate. I take it that the gentleman would stand
behind the language of the report ?

Mr. Murphy of New York. The committee did intend that the
Administrator not needlessly require animal testing.

Mr. OiTiXGER. I thank the gentleman.

The Chairmax. Are there further amendments to section 6? If
not, the Clerk will read.
The Clerk read as follows :

IMMINENT HAZARDS

Sec. 7. (a) Actions Authorized and Required. — (1) The Administrator may
file an action in a district court of the United States —

(A) for seizure of an imminently hazardous chemical substance or mixture
or any article containing such a substance or mixture.

(B) for relief (as authorized by subsection (b)) against any person who
manufactures, processes, or distributes in commerce an imminently hazardous
chemical substance or mixture or any article containing such a substance
or mixture, or

An action may be filed under this paragraph notwithstanding the existence of a
rule under section 4, 5. or 6, and notwithstanding the pendency of any administra-
tive or .judicial proceeding under any provision of this Act.

(2) If the Administrator has not made a rule under section 6(a) immediately
effective fas authorized by subsection 6(d) (2) (A) fi)) with respect to an im-
minently hazardous chemical substance or mixture, the Administrator shall file
in a district court of the United States with respect to such substance or mixture
or article containing such substance or mixture an action described in subpara-
graph CA), (B),or (C) or paragraph (1).

(b) Jurisdiction of Court. — (1) The district court of the Un^:ted States in
which an action under subsection (a) is brought shall have jurisdiction to grant

591

such temporary or permanent relief as may be necessary to protect health or the
environment from the unreasonable risk associated with the chemical substance,
mixture, or article involved in such action.

(2) In the case of an action under subsection (a) brought against a person who
manufactures, processes, or distributes in commerce a chemical substance or mix-
ture or an article containing a chemical substance or mixture, the relief authorized
by paragraph (1) may include the issuance of a mandatory order requiring (A) in
the case of purchasers of such substance, mixture, or article known to the
defendant, notification to such purchasers of the risk associated with it; (B)
public notice of such risk ; (C) recall ; (D) the replacement or repurchase of such
substance, mixture, or article; or (E) any combination of the actions described
in the preceding clauses.

(3) In the case of an action under subsection (a) against a chemical substance,
mixture, or article, such substance, mixture, or article may be proceeded against
by process of libel for its seizure and condemination. Proceedings in such an
action shall conform as nearly as possible to proceedings in rem in admiralty.

(c) Venue and Consolidation. — (1) (A) An action under subsection (a)
against a person who manufactures, processes, or distributes a chemical sub-
stance or mixture or an article containing a chemical substances or mixture
may be brought in the United States District Court for the District of Columbia
or for any judicial district in which any of the defendants is found, resides, or
transacts business ; and process in such an action may be served on a defendant in
any other district in which such defendant resides or may be found. An action
under subsection (a) against a chemical substance, mixture, or article may be
brought in any United States district court within the jurisdiction of which the
substance, mixture, or article is found.

(B) In determining the judicial district in which an action may be brought
under subsection (a) in instances in which such action may be brought in more
than one judicial district, the Administrator shall take into account the con-
venience of the parties.

(C) Subpenas requiring attendance of witnesses in an action brought under
subsection (a) may run into any judicial district.

(2) Whenever proceedings under subsection (a) involving identical chemical
substances, mixtures, or articles are i>ending in courts in two or more judicial
districts, they shall be consolidated for trial by order of any such court upon
application reasonably made by any party in interest, upon notice to all parties
in interest.

(d) Action Under Section 6. — Where appropriate, concurrently with the filing
of an action under subsection (a) or as soon thereafter as may be practicable,
the Administrator shall initiate a proceeding for the promulgation of a rule under
section 6(a).

(c) Representation. — Notwithstanding any other provision of law, in any
action under subsection (a), the Administrator may direct attorneys of the
Environmental Protection Agency to appear and represent the Administrator in
such an action.

(f) Definition. — For purposes of subsection (a), the term "imminpntly haz-
ardous chemical substance or mixture" means a chemical substance or mixture
which causes or .significantly contributes to an imminent and unreasonable risk
of serious or widespread harm to health or the environment. Such a risk to health
or the environment. shall be considered imminent if it is shown that the manu-
facture, processing, distribution in commerce, use. or disposal of the chemical
substance or mixture or any combination of such actions is likely to result in
such harm to health or the environment before a final rule under section 6 can
protect against such risk.

reporting and retention of information

Sec 8. (a) Reports. — (1) The Administrator shall promulgate rules under
which —

(A) each person (other than a small manufacturer or processor) who
manufactures or processes or proposes to manufacture or process a chemical
substance (other than a chemical substance described in subparns:raph
(B) (ii) ) shall maintain such records, and shall submit to the Administrator
such reports, as the Administrator may reasonably require, and

592

(B) each person (other than a small manufacturer or processor) who
manufactures or processes or proposes to manufacture or process —

(i) a mixture, or

(ii) a chemical substance in small quantities (as defined by the Ad-
ministrator by rule) solely for scientific experimentation or analysis
or for chemical research or analysis on such substance or another sub-
stance, including such research or analysis for the development of a
product,

shall maintain records and submit to the Administrator reports but only to
the extent the Administrator determines the maintenance of records or
submission of reports, or both, is necessary for the effective enforcement of
this Act.

The Administrator may not require in a rule promulgated under this paragraph
the maintenance of records or the submission of reports with respect to changes
in the proportions of the comiK)nents of a mixture unless the Administrator finds
that the maintenance of such records or the submission of such reports, or both,
is necessary for the effective enforcement of this Act. For purposes of the compila-
tion of the list of chemical substances required under subsection (b), the
Administrator shall promulgate rules pursuant to this subsection not later than
one hundred and eighty days after the effective date of this Act.

(2) The Administrator may require under paragraph (1) reporting with respect
to the following :

(A) The common or trade name, the chemical identity, and the molecular
structure of each chemical substance or mixture for which such a report is
required, insofar as known to the person making the report or insofar as
reasonably ascertainable.

(B) The categories or proposed categories of use of each such substance
or mixture, insofar as known to the person making the report or insofar
as reasonably ascertainable.

(C) Reasonable estimates of the amount of each substance and mixture
to be manufactured or processed and, insofar as known to the person making
the report or insofar as reasonably ascertainable, a reasonable estimate of
the amount of each such substance and mixture to be manufactured or
processed for each of its categories or proposed categories of use.

(D) A description of the byproducts resulting from the m^inufacture,
processing, use, or disposal of each such substance or mixture, insofar as
known to the person making the report or insofar as reasonably ascertain-
able.

(E) All existing data concerning the adverse environmental and health
effects of such substance or mixture, insofar as known to the person making
the report.

(F) Estimates of the number of persons who will be exposed to such
substance or mixture in their places of employment and the duration of such
exposure, insofar as known to the person making the report.

To the extent feasible the Administration shall not require under paragraph (1)
unnecessary or duplicate reporting.

(3) (A) (i) The Administrator may by rule require a small manufacturer or
processor of a chemical substance to submit to the Administrator such infor-
mation respecting the chemical substance as the Administrator may require for
publication of the first list of chemical substances required by subsection (b).

(ii) The Administrator may by rule require a small manufacturer or processor
of a chemical substance or mixture —

(I) subject to a rule proposed or promulgated under section 4, 5(c),
5(g), or 6, or .

(II) with respect to which relief has been granted pursuant to a civil
action brought under section 7, to maintain such records on such substance
or mixture, and to submit to the Administrator such reports on such sub-
stance or mixture, as the Administrator may reasonably require. A rule
under this clause requiring reporting may require reporting with respect to
the matters referred to in paragraph (2).

(B) The Administrator, after consultation with the Administrator of the
Small Business Administration, shall by rule prescribe standards for determining
the manufacturers and processors which qualifying as small manufacturers and
processors for purposes of this paragraph and paragraph (1).

593

(b) Inventory — (1) The Administrator shall compile, keep current, and
publish a list of each chemical substance which is manufactured or processed
in the United States. Such list shall at least include each chemical substance
which any person reports, under section 5 or subsection (a) of this section, is
manufactured or processed in the United States or was manufactured or
processed in the United States within three years before the effective date of
the rules promulgated pursuant to the last sentence of subsection (a)(1). In
the case of a chemical substance for which a notice is submitted in accordance
with section 5, such chemical substance shall be included in such list as of the
earliest date (as determined by the Administrator) on which such substance
was manufactured or processed in the United States. The Administrator shall
first publish such a list not later than one year after the effective date of this
Act. The Administrator shall not include in such list any chemical substance
which is manufactured or processed only in small quantities (as defined by the
Administrator by rule) solely for scientific experimentation or analysis or for
chemical research or analysis on such substance or another substance, including
such research or analysis for the development of a product.

(2) To the extent consistent with the purposes of this Act, the Administrator
may, in lieu of listing, pursuant to paragraph (1), a chemical substance indi-
vidually, list a category of chemical substances in which such substance is
included.

(c) Records. — Any person who manufactures, processes, or distributes in
commerce or proposes to manufacture, process, or distribute in commerce any
chemical substance or mixture shall, as required by the Administrator by rule,
maintain records of adverse reactions to health or the environment alleged to
have been caused by the substance or mixture. In such a rule the Administrator
may require that —

(1) records of adverse reactions to the health of employees be retained
for a period of not more than fifty years from the date such reactions were
first reported to or known by the person maintaining such records, and

(2) any other record be retained for a period of not more than five years
from the date the information contained in the record was first reported
to or known by the person maintaining the record.

Records required to be maintained under this subsection may include records of
consumer allegations of personal injury or harm to health, reports of occupa-
tional disease or injury, and reports or complaints of injury to the environment
submitted to the manufacturer, processor, or distributor in commerce by indi-
viduals or governmental agencies. Upon request of an officer or employee duly
designated by the Administrator, each person who is required to maintain records
under this subsection shall permit the inspection of such records and shall sub-
mit copies of such records.

(d) Health and Safety Studies. — The Administrator shall promulgate rules
under which the Administrator may require any person who manufactures, proc-
esses, or distributes in commerce or who proposes to manufacture, process, or
distribute in commerce any chemical substance or mixture (or with respect to
paragraph (2), any person who has possession of a study) to submit to the
Administrator —

(1) lists of health and safety studies conducted or initiated by or for
such person at any time or known to such person; and

(2) copies of any such studies appearing on a list submitted pursuant to
paragraph (1) or (2), or otherwise known by such person.

(e) Notice to Administrator of Unreasonable Risks. — Any person who
manufactures, processes, or distributes in commerce a chemical substance or
mixture and who obtains information which reasonably supports the conclusion
that such substance or mixture causes or significantly contributes to a sub-
stantial risk to health or the environment shall immediately inform the Adminis-
trator of such information unless such person has actual knowledge that the
Administrator has been adequately informed of such information.

(f) Definitions. — For purposes of this section, the terms "manufacture" and
"processes" mean manufacture or process for commercial purposes.

relationship to other federal laws

Sec. 9. (a) Laws Not Ai^ministered by the Administrator.— (1) If the
Administrator has reason tiLhelieVe that the manufacture, processing, distribu-
tion in commerce, useT of" disposal of a chemical substance or mixture or any

594

combination of such actions causes or significantly contributes to or is likely
to cause or significantly contribute to an unreasonable risk to health or the i
environment and determines that such risk may be prevented or reduced to a '
sufficient extent by action taken under a Federal law not administered by the '
Administrator, the Administrator shall submit to the agency which administers '
such law a report which describes such risk and includes in such description a
specification of , the activity or combination of activities which the Administrator
has reason to believe so causes or contributes to such risk. Such report shall
also request such agency —

(A) (i) to determine if the risk described in such report may be pre- 1
vented or reduced to a sufficient extent by action taken under such law, and !

(ii) if the agency determines that such risk may be so prevented or
reduced, to issue an order declaring whether or not the activity or combi-
nation of activities specified in the description of such risk causes or signifi-
cantly contributes to such risks ; and

(B) to report such determination and order to the Administrator.

Any report of the Administrator shall include a detailed statement of the
information on which it is based and shall be published in the Federal Register.
The agency receiving a request under such a report shall make the requested
determination, issue the requested order, and make the requested report within
such time as the Administrator specifies in the request, but such time specified i
may not be less than ninety days from the date the request was made. The report |
of an agency in response to a request of the Administrator shall be accompanied j
by a detailed statement of the findings and conclusions of the agency respecting J
the order and determination requested to be made and shall be published in the
Federal Register.

(2) If the Administrator makes a report under paragraph (1) with respect
to a chemical substance or mixture and the agency to which such report was
made either —

(A) issues an order declaring that the activity or combination of activ-
ities specified in the description of the risk described in the report does not
cause or significantly contribute to the risk described in the report, or

(B) initiates, within ninety days of the publication in the Federal Regis-
ter of the report of the agency under paragraph (1) in response to the
Administrator's report, action under the law (or laws) administered by
such agency to protect against such risk, the Administrator may not take
any action under section 6 or 7 with respect to such risk.

(3) If the Administrator has initiated action under section 6 or 7 with
respect to a risk associated with a chemical substance or mixture which was
the subject of a report made to an agency under paragraph (1), such agency
shall before taking action under the law (or laws) administered by it to protect
against such risk consult with the Administrator for the purpose of avoiding
duplication of Federal action against such risk.

(b) Laws Administered by the Administrator. — The Administrator shall
coordinate actions taken under this Act with actions taken under other Federal
laws administered in whole or in part by the Administrator. If a risk to health
or the environment associated with a chemical substance or mixture could be
eliminated or reduced to a sufficient extent by actions taken under the author-
ities contained in such other Federal laws, the Administrator shall use such
authorities to protect against such risk unless the Administrator determines
that it is in the public interest to protect against such risk by actions taken
under this Act. This subsection shall not be construed to relieve the Adminis-
trator of any requirement imposed on the Administrator by such other Federal
laws.

(c) Occupational Safety and Health. — In exercising any authority under
this Act, the Administrator shall not, for purposes of section 4(b)(1) of the
Occupational Safety and Health Act of 1970, be deemed to be exercising statutory
authority to prescribe or enforce standards or regulations affecting occupational
safety and health.

(d) Coordination. — In administering this Act, the Administrator shall con-
sult and coordinate with the Secretary of Health, Education, and Welfare and
the heads of any other appropriate Federal executive department or agency,
any relevant independent regulatory agency, and any other appropriate instru-
mentality of the Federal Government for the purpose of achieving the maximum
enforcement of this Act while imposing the least burdens of duplicative require-
ments on those subject to the Act and for other purposes. The Administrator

595

shall report annually to the Congress on actions taken to coordinate with such
other Federal departments, agencies, or instrumentalities, and on actions taken
to coordinate the authority under this Act with the authority granted under
other Acts referred to in subsection (b) .

RESEARCH, COLLECTION, DISSEMINATION, AND UTILIZATION OF DATA

Sec. 10 (a) AUTHORITY. — The Adminisitrator shall, in consultation and coopera-
tion with the Secretary of Health, Education, and Welfare and with other
heads of appropriate departments and agencies, conduct such research and moni-
toring as is necessary to carry out the purposes of this Act. The Administrator
may enter into contracts and may make grants for such research and monitoring.
Contracts may be entered into under this subsection without regard to sections
3&i8 and 3709 of the Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5).

(b) Data Systems. — (1) The Administrator shall establish, administer, and
be responsible for the continuing activities of an interagency committee which
will design, establish, and coordinate an eflBcient and eifective system, within
the Environmental Protection Agency, for the collection, dissemination to other
Federal departments and agencies, and use of data submitted to the Adminis-
trator under this Act.

(2) (A) The Administrator shall, in consultation with the Secretary of Health,
Education, and Welfare and other heads of appropriate departments and agencies
design, establish, and coordinate an efficient and effective system for the re-
trieval of toxicological and other scientific data which could be useful to the
Administrator in carrying out the purposes of this Act. Systematized retrieval
shall be developed for use by all Federal and other departments and agencies
with responsibilities in the area of regulation or study of chemical substances
and mixtures and their effect on health or the environment.

(B) The Administrator, in consultation with the Secretary of Health, Educa-
tion, and Welfare, is authorized to make grants and enter into contracts for
the development of a data retrieval system described in subparagraph (A).
Contracts may be entered into under this subparagraph without regard to
sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5).

inspections

Sec 11. (a) In GeneruVL. — For purposes of enforcement of this Act the Admin-
istrator, or any representative of the Administrator, duly designated by the
Administrator, may inspect any establishment, facility, or other premises in
which chemical substances or mixtures are manufactured, processed, stored, or
held before or after their distribution in commerce and any conveyance being
used to transport chemical substances or mixtures in connection with distribu-
tion in commerce. Such an inspection may only be made upon presenting appro-
priate credentials and a written notice to the owner, operator, or agent in
charge of the premises or conveyance to be inspected. A separate notice shall
be given for each such inspection, but a notice shall not be required for each
entry made during the period covered by the inspection. Each such inspection
shall be commenced and completed with reasonable promptness and shall be
conducted at reasonable times, within reasonable limits, and in a reasonable
manner.

(b) Scope. — (1) Ex<?ept as provided in paragraph (2), an inspection under
subsection (a) shall extend to all things within the premises or conveyance
inspected (including records, files, papers, processes, controls, and facilities)
bearing on whether the requirements of this Act applicable to the chemical
substances or mixtures within such premises or conveyance have been complied
with.

(2) No inspection under subsection (a) shall extend to —

(A) financial data,

(B) sales data other than shipment data,

( D ) personnel data, or

(E) research data (other than research data required by this Act),
unless the nature and extent of such data are described with reasonable speci-
ficity in the written notice required by subsection (a) for such inspection.

596

E3CPOBTS

Sec. 12. (a) General. — (1) Except as provided in paragraph (2) and subsection
(b), this Act (other than section 8) shall not apply to any chemical substance,
mixture, or an article containing a chemical substance or mixture if —

(A) it can be shown that such substance, mixture, or article is being
manufactured, processed, sold, or held for sale, for export from the United
States, unless such substance, mixture, or article was, in fact, manufac-
tured, processed, or distributed in commerce, for use in the United States,
and

(B) such substance, mixture, or article when distributed in commerce,
or any container in which it is enclosed when so distributed, bears a stamp
or label stating that such substance, mixture, or article is intended for
export.

(2) If any person exports or intends to export to a foreign country a chemical
substance or mixture for which a rule has been proposed or promulgated under
section 5 or 6, or wuth respect to which an action is pending, or relief has been
granted under section 7, such person shall notify the Administrator of such
exportation or intent to export and the Administrator shall furnish to the
government of such country notice of such rule, action, or relief.

ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES

Sec 13. (a) In General. — (1) The Secretary of the Treasury shall refuse entry
into the customs territory of the United States (as defined in general headnote 2
to the Tariff Schedules of the United States) of any chemical substance, mixture,
or article containing a chemical substance or mixture offered for entry if —

(A) it fails to comply with any rule in effect under this Act, or

(B) it is offered for entry in violation of section 5, a rule or order under
section 5 or 6, or an order issued in an action brought under section 5 or 7.

(2) If a chemical substance, mixture, or article is refused entry under para-
graph (1), the Secretary of the Treasury shall notify the consignee of such entry
refusal, shall not release it to the consignee, and shall cause its disposal or storage
(under such rules as the Secretary of the Treasury may prescribe) if it has not
been exported by the consignee within ninety days from the date of receipt of
notice of such refusal, except that the Secretary of the Treasury may, pending
a review by the Administrator of the entry refusal, release to the consignee such
substance, mixture, or article on execution of bond for the amount of the full
invoice of such substance, mixture, or article (as such value is set forth in the
customs entry), together with the duty thereon. On failure to return such sub-
stance, mixture, or article for any cause to the custody of the Secretary of the
Treasury when demanded, such consignee shall be liable to the United States for
liquidated damages equal to the full amount of such bond. All charges for
storage, cartage, and labor on substances, mixtures, or articles which are refused
entry or release under this section shall be paid by the owner or consignee, and
in default of such payment shall constitute a lien against any future entry made
by such owner or consignee.

(b) Rules. — The Secretary of the Treasury, after consultation with the
Administrator, shall issue rules for the enforcement of subsection (a) of this
section.

597

DISCLOSUBE OF DATA

Sec. 14. (a) In General. — Except as provided by subsection (b), any informa-
tion reported to, or otherwise obtained by, the Administrator (or any rep-
resentative of the Administrator) unaer this Act, which is exempt from dis-
closure pursuant to subsection (a) of section 552 of title 5, United States
Code, by reason of subsection (b) (4) of such section, shall not be discolsed by
the Administrator or by any officer or employee of the United States, except
that such information may be disclosed —

(1) to officers and employees of the United States —

(A) in connection w^ith their official duties under laws for the protec-
tion of health or the environment, or

(B) for specific law enforcement purposes ;

(2) to contractors with the United States and employees of such eon-
tractors if in the opinion of the Administrator such disclosure is necessary
for the satisfactory performance by the contractor of a contract with the
United States entered into on or after the effective date of this Act for the
perfonnance of work in connection with this Act; or

(3) when relevant in any proceeding under this Act, except that disclosure
in such a proceeding shall be made in such manner as to preserve confiden-
tiality to the extent practicable without impairing the proceeding.

(b) Data From Health and Safety Studies. — (1) Subsection (a) does not
prohibit the disclosure of —

(A) any health and safety study submitted under this Act with respect
to—

(i) any chemical substance or mixture which on the date the study
is to be disclosed has been offered for commercial distribution, or

(ii) any chemical substance or mixture for which testing is required
under section 4 or for which notification is required under section 5,
and

(B) any data reported to, or otherwise obtained by the Administrator
from a health and safety study which relates to a chemical substance or
mixture described in clause (i) or (ii) of subparagraph (A).

Thi« paragraph does not authorize the release of data which discloses processes
used in the manufacturing or processing of a chemical substance or mixture or,
in the case of a mixture, the release of data disclosing the portion of the mix-
ture comprised by any of the chemical substances in the mixture.

(2) If a request is made to the Administrator under subsection (a) of section
552 of title 5, United States Code, for information which is described in the
first sentence of paragraph (1) and which is not information described in the
second sentence of such paragraph, the Administrator may not deny such request
on the basis of subsection (b) (3) or (b) (4) of such section.

(c) Designation of Confidential Data; Disputes. — (1) In submitting data
under this Act, a person may (A) designate the data which the person believes
is entitled to confidential treatment under subsection (a), and (B) submit such
designated data separately from other data submitted under this Act.

(2) If the Administrator proposes to release for insi)ection data which has
been designated under paragraph (1)(A), the Administrator shall notify, in
writing and by certified mail, the person who submitted such data of the intent
to release such data. If the release of such data is to be made pursuant to a
request made under section 552(a) of title 5, United States Code, such notice
shall be given immediately upon approval of such request by the Administrator.
The Administrator may not release such data until the expiration of thirty days
after the person submitting such data has received the notice required by this
paragraph.

(d) Criminal Penalty for Wrongful Disclosure. — (1) Any officer or em-
ployee of the United States or former officer or employee of the United States,
who by virtue of such employment or official position has obtained possession
of, or has access to, material the disclosure of which is prohibited by subsection
(a), and who knowing that disclosure of such material is prohibited by such
sub«;ection, willfully discloses the material in any manner to any person not
entitled to receive it. shall be guilty of a misdemeanor and fined not more than
$5,000 or imprisoned for not more than one year, or both. Section 1905 of title 18,
United States Code, does not apply with respect to the publishing, divulging,

598

disclosure, or making known of, or making available, information reported or
otherwise obtained under this Act.

(2) For the purposes of paragraph (1), any contractor with the United States
who is furnished information as authorized by subsection (a)(2), and any
employee of any such contractor, shall be considered to be an employee of the
United States.

(e) Access by Congress. — Notwithstanding any limitation contained in this
section or any other provision of law, all information reported to or otherwise
obtained by the Administrator (or any representative of the Administrator)
under this Act shall be made available, upon written request of any duly au-
thorized committee of the Congress, to such committee.

PROHIBITED ACTS

Sec. 15. It shall be unlawful for any person to —

(1) fail or refuse to comply with (A) any rule or order promulgated or
issued under section 4, (B) any requirement prescribed by section 5, or
( C ) any rule or order promulgated under section 5 or 6 ;

(2) use for commercial purposes a chemical substance or mixture which
such person knew or had reason to know was manufactured, processed, or
distributed in commerce in violation of section 5, a rule or order under
section 5 or 6, or an order issued in an action brought under section 5 or 7 ;

(3) fail or refuse to (A) establish or maintain records, (B) submit re-
ports, notices, or other information, or (C) permit access to or copying of
records, as required by this Act or a rule thereunder ; or

(4) fail or refuse to permit entry or inspection as required by section 11.

PENALTIES

Sec. 16. (a) Civil. — (1) Any person who violates a provision of section 15
of this Act shall be liable to the United States for a civil penalty in an amount
not to exceed $25,000 for each such violation. Each day such violation continues
shall for purposes of this subsection constitute a separate violation of section 15.

(2) (A) A civil penalty for a violation of section 15 shall be assessed by the
Administrator by an order made on the record after opportunity (provided in
accordance with this subparagraph) for a hearing in accordance with section
554 of title 5, United States Code. Before issuing such an order, the Administra-
tor shall give written notice to the person to be assessed a civil penalty under
such order of the Administrator's proposal to issue such order and provide
such person an opportunity to request, within fifteen days of the date the notice
is received by such person, such a hearing on the order.

(B) In determining the amount of a civil penalty, the Administrator shall
take into account the nature, circumstances, extent, and gravity of the violation
or violations and, with respect to the violator, ability to pay, effect on ability
to continue to do business, any history of prior such violations, the degree of
culpability, and such other matters as justice may require.

(C) The Administrator may, in the Administrator's discretion, compromise,
modify, or remit, with or without conditions, any civil penalty which may be
imposed under this subsection. The amount of such i)en'alty, when finally deter-
mined, or the amount agreed upon in compromise, may be deducted from any
sums owing by the United States to the person charged.

(3) Any person who requested in accordance with paragraph (2) (A) a hear-
ing respecting the assessment of a civil penalty and who is aggrieved by an order
assessing a civil penalty may file a petition for judicial review of such order with
the United States Court of Appeals for the District of (Columbia Circuit or for
any other circuit in which such person resides or transacts business. Such a
petition may only be filed within the thirty-day period beginning on the date
the order making such assessment was issued.

(4) If any person fails to pay an assessment of a civil i)enalty after it has
become a final order and does not file a petition for judicial review of the order
in accordance with paragraph (3) or after a court in an action brought under
paragraph (3) has entered final judgment in favor of the Administrator, the
Attorney General shall recover the amount assessed (plus interest at currently
prevailing rates from such date) in an action brought in any appropriate district
court of the United States. In such an action, the validity, amount, and appro-
priateness of such penalty shall not be subject to review.

599

(b) Criminal. — Any person who knowingly or willfully violates any provi-
sion of section 15 shall, in addition to or in lieu of a civil penalty which may be
imposed under subsection (a) of this section for such violation, be subject, upon
conviction, to a fine of not more than $25,000 for each day of violation, or to
imprisonment for not more than one year, or both.

(c) Notice, Repurchase, or Replacement.— If in a proceeding for the issu-
ance of an order under paragraph (1) to assess a civil penalty against a person
the Administrator determines that such person manufactured, processed, or
distributed in commerce a chemical substance or mixture in violation of a
requirement applicable to such substance or mixture under paragraph (1) or
(2) of section G(a) or otherwise determines by order made on the record after
opportunity for agency hearing that a person has so violated such a requirement,
the Administrator may, in such order, require such person (1) to give notice
of the risk associatated with the chemical substances or mixture subject to
such requirement to processors or distributors in commerce of such substance
or mixture, or to both, and, to the extent reasonably ascertainable, to any other
per.son in possession of or exposed to such substance or mixture; (2) to give
public notice of such risk; (3) to either replace or repurchase such substance
or mixture, as determined by the person (or persons) to whom the requirement
is directed, in the manner prescribed by the Administrator; or (4) to take any
combination of the actions described in the preceding clauses.

SPECIFIO enforcement AND SEIZURE

Sec. 17. (a) Specific Enforcement. — (1) The district courts of the United
States shall have jurisdiction over civil actions to —

(A) restrain any violation of section 15,

(B) restrain any person from manufacturing or processing a chemical
substance before the expiration of the period before which such manufac-
turing or processing is prohibited under section 5,

(D) compel the taking of any action required by or under this Act.
(2) A civil action described in paragraph (1) may be brought —

(A) in the case of a civil action described in subparagraph (A) of such
paragraph, in the United States district court for the judicial district
wherein any act, omission, or transaction constituting a violation of section
15 occurred or wherein the defendant is found or transacts business, or

(B) in the case of any civil action described in such paragraph, in the
United States district court for the judicial district wherein the defendant
is found or transacts business.

In any such civil action process may be sen-ed on a defendant in any judicial
district in which a defendant resides or may be found. Subpenas requiring
attendance of witnesses in any such action may run into any judicial district.

(b) Seizure. — Any chemical substance, or mixture which was manufactured,
processed, or distributed in commerce in violation of this Act or any rule or order
promulgated under this Act or any article containing such a substance or mix-
ture shall be liable to be proceeded against by process of libel for the seizure and
condemnation of such substance, mixture, or article, in any district court of the
United States within the jurisdiction of which such substance, mixture, or arti-
cle is found. Such proceedings shall conform as nearly as possible to proceedings
in rem in admiralty.

preemption

Sec. 18. (a) Effect on State Law. — (1) Exempt as provided in paragraph (2),
nothing in this Act shall affect the authority of any State or political subdivision
of a State to establish or continue in effect regulation of any chemical sub-
stance, mixture, or article containing a chemical substance or mixture.
(2) Except as provided in subsection (b) —

(A) if the Administrator requires by a rule promulgated under section
4 the testing of a chemical substance or mixture, no State or political sub-
division may, after the effective date of such rule, establish or continue in
effect a requirement for the testing of such substance or mixture for pur-
poses similar to those for which testing is required under such rule ; and

(B) if the Administrator prescribes a rule or order under section 5 or
6 of this Act (other than a rule imposing a requirement described in sub-

600

section (a) (5) of section 6) which is applicable to a chemical substance
or mixture, and which is designed to protect against a risk to health or the
environment associated with such substance or mixture, no State or political
subdivision of a State may, after the effective date of such requirement,
establish or continue in effect a requirement applicable to such substance or
mixture, or an article containing such substance or mixture, and designed
to protect against such risk unless such requirement is identical to the
requirement prescribed by the Administrator or unless such requirement is
adopted under the authority of the Clean Air Act or any other Federal law.
(b) Exemption. — Upon application of a State or political subdivision of a
State the Administrator may be rule exempt from subsection (a) (2), under such
conditions as may be prescribed in such rule, a requirement of such State or
political subdivision designed to protect against a risk to health or the environ-
ment associated with a chemical substance, mixture, or article containing a
chemical substance or mixture if —

(1) compliance with the requirement would not cause the manufacturing,
processing distribution in commerce, or use of the substance, mixture, or
article to be in violation of the applicable requirement imder this Act
described in subsection (a) (2), and

(2) the State or political subdivision requirement (A) provides a sig-
nificantly higher degree of protection from such risk than the requirement
under this Act described in subsection (a) (2) and (B) does not, through
diflBculties in marketing distribution, or other factors, unduly burden inter-
state commerce.

JUDICIAL BEVIEW

Sec. 19. (a) In General. — Not later than sixty days following the promulga-
tion of a rule under section 4, 5, or 6(a) of this Act, any person may file a
petition for judicial review of such rule with the United States Court of Appeals
for the District of Columbia Circuit or for the circuit in which such person
resides or in which such person's principal place of business is located. Copies
of the petition shall be forthwith transmitted by the clerk of such court to the
Administrator and to the Attorney General. The Administrator shall transmit
to the Attorney General, who shall file in the court, the record of the proceedings
on which the Administrator based such rule as provided in section 2112 of title
28, United States Code. For purposes of this section, the term "record" means
such rule ; any transcript required of any oral presentation ; any written sub-
mission of interested parties ; and any other information which the Admin-
istrator considers to be revelant to such rule and with respect to which the
Administrator, on or before the date of the promulgation of such rule, pubUsh
a notice in the Federal Register identifying such information.

(b) Additional Data. — If the i)etitioner applies to the court for leave to
adduce additional data, views, or arguments, and shows to the satisfaction of
the court that such additional data, views, or arguments are material and that
there are reasonable grounds for the petitioner's failure to adduce such data,
views, or arguments in the proceeding before the Administrator, the court may
order the Administrator to provide additional opportunity for oral presentation
of data, views, or arguments and for written submissions. The Administrator
may modify findings or determinations upon which the rule subject to review
by such court was based, or make new findings or determinations by reason of
the additional data, views, or arguments so taken and shall file such modified
or new findings or determinations, and the Administrator's recommendation, if
any, for the modification or setting aside of such rule, with the return of such
additional data, views, or arguments.

(c) Authority and Review Standard. — (1) Upon the filing of a petition
under subsection (a), the court shall have jurisdiction (A) to review the rule
involved, in accordance with chapter 7 of title 5, United States Code, and (B) to
grant appropriate relief, including interim relief, as provided in such chapter.
Any rule promulgated by the Administrator under section 4, 5, or 6 of this Act
and reviewed under this section shall be aflirmed, unless the determination or
findings required to be made by the Administrator under the applicable section
are not supported by substantial evidence on the record taken ^s a whale.

(2) The judgment of the court aflirming or setting aside, in whole or in part,
any rule reviewed in accordance with this section shall be final, subject to review
by the Supreme Court of the United States upon certiorari or certification, as
provided in section 1254 of title 28, United States Code.

601

(3) The judgment of the court in an action (a) may include an award of
cosis of suit and reasonable fees for attorneys and expert witnesses if the court
determines that such an award is appropriate. The Supreme Court of the
United States in its decision on a review of judgment in such an action may
provide for the award of costs of suit and reasonable fees for attorneys if the
court determines that such an award is appropriate.

(d) Other Remedies. — The remedies provided in this section shall be in addi-
tion to and not in lieu of any other remedies provided by law.

citizens' civil actions

Sec. 20. (a) In Genebal. — Except as provided in subsection (b), any person may
commence a civil action —

(1) against any person (including (A) the United States, and (B) any
other governmental instrumentality or agency to the extent permitted by
the eleventh amendment to the Constitution) who is alleged to be in viola-
tion of this Act or any rule prescribed under section 4, 5, or 6(a) to restrain
such violation, or

(2) against the Administrator to compel the Administrator to perform
any act or duty under this Act which is not discretionary.

Any civil action under paragraph (1) shall be brought in the United States
district court for the district in which the alleged violation occurred or in
which the defendant resides or in which the defendant's principal place of busi-
ness is located. Any action brought under paragraph (2) shall be brought in the
United States District Court for the District of Columbia, or the United States
district court for the judicial district in which the plaintiff is domiciled. The
district courts shall have jurisdiction over suits brought under this section,
without regard to the amount in controversy or the citizensliip of the parties.
In any civil action under this subsection process may be served on a defendant
in any judicial district in which the defendant resides or may be found and
subpenas for witnesses may run into any judicial district.

(b) Limitation. — No civil action may be commenced —

(1) under subsection (a)(1) to restrain a violation of this Act or rule
under this Act —

(A) before the expiration of sixty days after the plaintiff has given
notice of such violation (i) to the Administrator, and (ii) to the person
who is alleged to have committed such violation, or

(B) if the Administrator (or the Attorney General on behalf of the
Administrator) has commenced and is diligently prosecuting a civil
action in a court of the United States to require compliance with this
Act or such rule, but if such action is commenced after the giving of
notice, any person giving such notice may intervene as a matter of right
in such action ; or y

(2) under subsection (a) (2) before the expiration of sixty days after
the plaintiff has given notice to the Administrator of the alleged failure of
the Administrator to perform an act or duty which is the basis for such
action or, in the case of an action under such subsection for the failure of
the Administrator to file an action under section 7. before the expiration
of ten days after such notification.

Notice under this subsection shall be given in such manner as the Administrator
shall prescribe by rule.

(c) General. — (1) In any action under this section, the Administrator, if
not a party, may intervene as a matter of right.

(2) The court, in issuing any final order in any action brought pursuant to
subsection (a), may award costs of suit and reasonable fees for attorneys and
expert witnesses if the court determines that such an award is appropriate.
Any court, in issuing its decision in an action brought to re\'iew such an order,
may award costs of suit and reasonable fees for attorneys if the court deter-
mines that such an award is appropriate.

(3) Nothing in this section shall restrict any right which any person (or class
of persons) may have under any statute or common law to seek enforcement of
this Act or any rule under this Act or to seek any other relief.

79-313 O - 77 - 39

602

tion of such defendants to such actions which is made to a court in which any
such action is brought, may, if such court in its discretion so decides, be con-
solidated for trial oy order (issued after giving ail parties reasonable notice
and opportunity to be heard) of such court and tried in —

(1) any district which is selected by such defendant and in which one of
such actions is pending,

(2) a district which is agreed upon by stipulation between all the parties
to such actions and in which one of such actions is pending, or

(3) a district which is selected by the court and in which one of such
actions is pending.

The court issuing such an order shall give prompt notification of the order to the
other courts in which the civil actions consolidated under the order are pending.

citizens' PETITIQjSrS

Sec. 21. (a) In General. — Any person may petition the Administrator to
initiate a proceeding for the issuance, amendment, or repeal of a rule under
section 4, 5(c), or 6(a).

(b) Procedure. — (1) Such petition shall be filed in the principal oflSce of
the Administrator and shall set forth the facts which it is claimed establish that
it is necessary to issue, amend, or repeal a rule under section 4, 5(c), or 6(a).

(2) The Administrator may hold a public hearing or may conduct such inves-
tigation or proceeding as the Administrator deems appropriate in order to deter-
mine whether or not such petition should be granted.

(3) Within ninety days after filing of a petition described in paragraph (1),
the Administrator shall either grant or deny the petition. If the Administrator
grants such petition, the Administrator shall promptly commence an appropriate
proceeding in accordance with section 4, 5(c), or 6(a). If the Administrator
denies such petition, the Administrator shall publish in the Federal Register
the Administrator's reasons for such denial.

(4) (A) If the Administrator denies a petition filed under this section (or if
the Administrator fails to grant or deny such petition within the ninety-day
period) the petitioner may commence a civil action in a United States district
court to compel the Administrator to initiate a rulemaking proceeding to take
the action requested. Any such action shall be filed within sixty days after the
Administrator's denial of the petition or, if the Administrator fails to grant or
deny the petition within ninety days after filing the petition, within sixty days
after the expiration of the ninety-day period.

(B) If in an action under subparagraph (A) respecting a petition to initiate
a proceeding to issue a rule under section 4, 5(c), or 6(a) the petitioner demon-
strates to the satisfaction of the court, by a preponderance of the evidence in a
de novo proceeding before the court, that —

(i) in the case of a petition to initiate a proceeding for the issuance of a
rule under section 4, that the manufacture, distribution in commerce, proc-
essing, use, or disposal of the chemical substance or mixture to be subject
to such rule may cause or significantly contribute to an unreasonable risk
to health or the environment,

(ii) in the case of a petition to initiate a proceeding for the issuance of
a rule under section 5(c), that the manufacture, processing, distribution in
commerce, use, or disposal of a chemical substance petitioned to be included
in a list compiled under such rule causes or significantly contributes to or
may cause or significantly contribute to an unreasonable risk to health or
the environment, or

(iii) in the case of a petition for the issuance of a rule under section 6(a),
that there is a reasonable basis to conclude that the manufacture, processing,
distribtuion in commerce, use, or disposal of a chemical substance or mix-
ture to be subject to such rule causes or significantly contributes to or will
cause or significantly contribute to an unreasonable risk to health or the
environment.

the court shall order the Administrator to initiate the action requested by the
petitioner unless the court finds, after considering the extent of the risk to
health or the environment alleged by the petitioner in relation to the extent of
risks to health or the environment with respect to which the Administrator is
taking nction under this Act, the resources available to the Administrator to
take the action requested by the petitioner, and other relevant factors, the fail-
ure of the Administrator to initiate such action was not unreasonable.

603

(C) The court in issuing any final order in any action brought pursuant to
subparagraph (A) may award costs of suit and reasonable fees for attorneys
and expert witnesses if the court determines that such an award is appropriate.
Any court, in issuing its decision in an action brought to review such an order,
may award costs of suit and reasonable fees for attorneys if the court deter-
mines that such an award is appropriate.

(5) The remedies under this section shall be in addition to, and not in lieu of,
other remedies provided by law.

NATIONAL DEFENSE WAIVER

Sec. 22. The Administrator shall waive compliance with any provision of this
Act upon a request and determination by the President that the requested waiver
is necessary in the interest of national defense. The Administrator shall main-
tain a written record of the basis upon which such waiver was granted and
make such record available for in camera examination when relevant in a judi-
cial proceeding under this Act. Upon the issuance of such a waiver, the Admin-
istrator shall publish in the Federal Register a notice that the waiver was
granted for national defense purposes, unless, upon the request of the President,
the Administrator determines to omit such publication because the publication
itself would be contrary to the interests of national defense, in which event the
Administrator shall submit notice thereof to the Armed Services Committees of
the Senate and the House of Representatives.

EMPLOYEE PROTECTION

Sec. 23. (a) In General, — No employer may discharge any employee or other-
wise discriminate against any employee with respect to the employee's compensa-
tion, terms, conditions, or privileges of employment because the employee (or
any person acting pursuant to a request of the employee) has —

(1) commenced, caused to be commenced, or is about to commence or
cause to be commenced a proceeding under this Act ;

(2) testified or is about to testify in any such proceeding; or

(3) assisted or participated or is about to assist or participate in any
manner in such a proceeding or in any other action to carry out the purposes
of this Act.

(b) Remedy. — (1) Any employee who believes that the employee has been dis-
charged or otherwise discriminated against by any person in violation of sub-
section (a) of this section may, within thirty days after such alleged violation
occurs, file (or have any person file on the employee's behalf), a complaint with
the Secretary of Labor (hereinafter in this section referred to as the "Secre-
tary") alleging such discharge or discrimination. Upon receipt of such a com-
plaint, the Secretary shall notify the person named in the complaint of the filing
of the complaint.

(2) (A) Upon receipt of a complaint filed under paragraph (1), the Secretary
shall conduct an investigation of the violation alleged in the complaint. Within
thirty days of the receipt of such complaint, the Secretary shall complete such
investigation and shall notify in writing the complainant (and any person acting
on behalf of the complainant) and the person alleged to have committed such
violation of the results of the investigation conducted pursuant to this paragraph.
Within ninety days of the receipt of such complaint the Secretary shall, unless
the proceeding on the complaint is terminated by the Secretary on the basis of a
settlement entered into by the Secretary and the person alleged to have com-
mitted such violation, issue an order either providing the relief prescribed by
subparagraph (B) or denying the complaint. An order of the Secretary shall be
made on the record after notice and opportunity for agency hearing. The Secre-
tary may not enter into a settlement terminating a proceeding on a complaint
without the participation and consent of the complainant.

(B) If in response to a complaint filed under paragraph (1) the Secretary deter-
mines that a violation of subsection (a) of this section has occurred, the Secretary
shall order (i) the person who committed such violation to take affirmative action
to abate the violation, (ii) such person to reinstate the complainant to the com-
plainant's former position together with the compensation (including back pay),
terms, conditions, and privileges of the complainant's employment, (iii) com-
pensatory damages, and (iv) where appropriate, exemplary damages. If such an
order is issued, the Secretary, at the request of the complainant, shall assess
against the person against whom the order is issued a sum equal to the aggregate

604

amount of all costs and expenses (including attorney's fees) reasonably incurred,
as determined by the Secretary, by the complainant for, or in connection with, the
bringing of the complaint upon which the order was issued.

(c) Review.— (1) Any person adversely affected or aggrieved by an order issued
under subsection (b) may obtain review of the order in the United States Court
of Appeals for the circuit in which the violation, with respect to which the order
was issued, allegedly occurred. The petition for review must be filed within sixty
days from the issuance of the Secretary's order. Review shall conform to chapter
7 of title 5 of the United States Code.

(2) An order of the Secretary, with respect to which review could have been
obtained under paragraph (1), shall not be subject to judicial review in any crim-
inal or other civil proceeding.

(d) Enforcement. — (1) Whenever a person has failed to comply with an order
issued under subsection (b)(2), the Secretary shall file a civil action in the
United States district court for the district in which the violation was found to
occur to enforce such order. In actions brought under this subsection, the district
courts shall have jurisdiction to grant all appropriate relief, including injunctive
relief and compensatory and exemplary damages. Civil actions brought under this
subsection shall be heard and decided expeditiously.

(2) Any nondiscretionary duty imposed by this section is enforceable in man-
damus proceeding brought under section 1361 of title 28, United States Code.

(e) Exclusion. — Subsection (a) of this section shall not apply with respect to
any employee who, acting without direction from the employee's employer (or any
agent of the employer), deliberately causes a violation of any requirement of this
Act.

EMPLOYMENT EFFECTS

Sec. 24. (a) In Geneeal. — The Administrator shall evaluate on a continuing
basis the potential effects on employment (including reductions in employment
or loss of employment from threatened plant closures) of —

(1) the issuance of a rule or order under section 4, 5, or 6, or

(2) a requirement of section 5.

(b) (1) Investigations. — Any employee (or any representative of an employee)
may request the Administrator to make an investigation of —

(A) a discharge or layoff or threatened discharge or layoff (ft the employee, <

(B) adverse or threatened adverse effects on the employee's employment,
allegedly resulting from a rule or order under section 4, 5, or 6 or a requirement of
section 5. Any such request shall be made in writing, shall set forth with reason-
able particularity the grounds for the request, and shall be signed by the employee,
or representative of such employee, making the request.

(2) (A) Upon receipt of a request made in accordance with paragraph (1) the
Administrator shall (i) conduct the investigation requested, and (ii) if requested
by any interested person, hold public hearings on any matter involved in the in-
vestigation unless the Administrator determines that there are no reasonable
grounds for holding such hearings. If the Administrator makes such a determina-
tion respecting a request for a hearing, the Administrator shall notify in writing
the person requesting the hearing of the determination and the reasons therefor.

(B) If public hearings are to be held on any matter involved in an investiga-
tion conducted under this subsection —

(i) at least five days' notice shall be provided the person making the re-
quest for the investigation and any person identified in such request,

(ii) a transcript shall be made of the hearings, and

(iii) each employee who made or for whom was made a request for such
hearings and the employer of such employee shall be required to present in-
formation respecting the applicable matter referred to in paragraph (1) (A)
or (1) (B) together with the basis for such information.

(3) Upon completion of an investigation under paragraph (2), the Administra-
tor shall make findings of fact, shall make such recommendations as the Admin-
istrator deems appropriate, and shall make available to the public such findings
and recommendations.

(4) In connection with any investigation or public hearing conducted under this
subsection, the Administrator may issue subpenas for the attendance and testi-
mony of witnesses and the production of relevant i>apers, books, and documents,
and the Administrator may administer oaths. Witnesses summoned shall be paid

605

the same fees and mileage that are paid witnesses in the courts of the United
States. In case of contumacy or refusal to obey a subpena served upon any person
under this paragraph, the United States district court for any district in which
such person is found or resides or transacts business, upon application by the
United States and after notice to such person, shall have jurisdiction to issue an
order requiring such person to appear and give testimony before the Administra-
tor to appear and produce papers, books, and documents before the Administrator,
or both, and any failure to obey such order of the court may be punished by such
court as a contempt thereof.

STUDIES

Sec. 25. (a) Indemnification Study. — The Administrator shall conduct a study
of all Federal laws administered by the Administrator for the purpose of deter-
mining whether and under what conditions, if any, indemnification should be
accorded any person as a result of any action taken by the Administrator under
any such law. The study shall —

(1) include an estimate of the probable cost of any indemnification pro-
grams which may be recommended ;

(2) include an examination of all viable means of financing the cost of any
recommended indemnification; and

(3) be completed and submitted to Congress not less than two years from
the effective date of this Act.

The General Accounting OflSce shall review the adequacy of the study submitted
to Congress pursuant to paragraph (3) and shall report the results of its review
to the Congress within six months of the date such study is submitted to
Congress.

(b) Classification, Storage, and Retrieval Study. — The Council on Environ-
mental Quality, in consultation with the Administrator, the Secretary of Health,
Education, and Welfare, the Secretary of Commerce, and the heads of other ap-
propriate Federal departments or agencies, shall coordinate a study of the feasi-
biUty of establishing (1) a standard classification system for chemical substances
and related substances, and (2) a standard means for storing and for obtaining
rapid access to information respecting such substances, A report on such study
shall be completed and submitted to Congress not later than eighteen months
after the effective date of this Act.

administration* of act

Sec. 26. (a) Cooperation of Federal Agencies. — Upon request by the Admin-
istrator, each Federal department and agency is authorized —

(1) to make its services, personnel, and facilities available (with or with-
out reimbursement), to the Administrator to assist the Administrator in the
administration of this Act ; and

(2) to furnish to the Administrator such information, data, estimates, and
statistics, and to allow the Administrator access to all information in its
possession as the Administrator may reasonably determine to be necessary
for the administration of this Act.

(b) Fees. — The Administrator may, by rule, require the payment of a reason-
able fee from any person required to submit data under section 4 or 5 of this Act
to defray the cost of administering this Act. Such rules shall not provide for any
fee in excess of $2,500. In setting such a fee, the Administrator shall take into
account the ability to pay of the person required to submit the data and the cost
to the Administrator of reviewing such data. Such rules may provide for sharing
such a fee in any case in which the expenses for testing are shared under section
4 or 5 of this Act.

(c) Action With Respect to Categories. — (1) Any action authorized or re-
quired to be taken by the Administrator under any provision of this Act with
respect to a chemical substance or mixture may be taken by the Administrator
in accordance with that provision with respect to a category of chemical sub-
stances or mixtures. Whenever the Administrator takes action under a provision

I of this Act with respect to a category of chemical substances or mixtures, any
reference in this Act to a chemical substance or mixture (insofar as it relates to
such action ) shall be deemed to be a reference to each chemical substance or mix-
ture in such category.

606 1

(2) For purposes of paragraph (1) : .]

(A) The term "category of chemical substances" means a group of chemi-j
cal substances the members of which are similar in molecular structure, inj
physical, chemical, or biological properties, in use, or in mode of entrance]
into the human body or into the environment, or the members of which are in]
some other way suitable for classification as such for purposes of this Act^
except that such term does not mean a group of chemical substances which
are grouped together solely on the basis of their being new chemical
substances.

(B) The term "category of mixtures" means a group of mixtures the mem-
bers of which are similar in molecular structure, in physical, chemical, or
biological properties, in use, or in mode of entrance into the human body or
into the environment, or the members of which are in some other way suitable
for classification as such for purposes of this Act.

(d) Assistance Office. — The Administrator shall establish in the Environ*
mental Protection Agency an identifiable oflBce to provide technical and other
nonfinancial assistance to manufacturers and processors of chemical substances
and mixtures respecting the requirements of this Act applicable to such manu-
facturers and processors, the policy of the Agency respecting the application of
such requirements to such manufacturers and processors, and the means and
methods by which such manufacturers and processors may comply with such
requirements.

DEVELOPMENT AND EVALUATION OF TEST METHODS

Sec. 27. (a) The Secretary of Health, Education, and Welfare, in consultation
with the Administrator and acting through the Assistant Secretary for Health,
may conduct, and make grants to public and nonprofit private entities and enter
into contracts with public and private entities for, projects for the development
and evaluation of inexpensive and efficient methods (1) for determining and
evaluating the health and environmental effects of chemical substances and mix-
tures, and their toxicity, persistence, and other characteristics which affect
health and the environment, and (2) which may be used for the development of
test data to meet the requirements of rules promulgated under section 4. The
Administrator shall consider such methods in prescribing under section 4 stand-
ards for the development of test data.

(b) No grant may be made or contract entered into under subsection (a) unless
an application therefor has been submitted to and approved by the Secretary.
Such an application shall be submitted in such form and manner and contain
such information as the Secretary may require. The Secretary may apply such
conditions to grants and contracts under subsection (a) as the Secretary deter-
mines are necessary to carry out the purposes of such subsection. Contracts may
be entered into under such subsection without regard to sections 3648 and 3709
of the Revised Statutes (31 U.S.C. 529 ; 41 U.S.C. 5).

(c) (1) The Secretary shall prepare and submit to the President and the Con-
gress on or before January 1 of each year a report of the number of grants made
and contracts entered into under this section and the results of such grants and
contracts.

(2) The Secretary shall periodically publish in the Federal Register reports
describing the progress and results of any contract entered into or grant made
under this section.

AUTHORIZATION FOB APPROPRIATIONS

Sec. 28. There are authorized to be appropriated to the Administrator for
purposes of carrying out this Act (other than section 27 thereof) $11,100,000 for
the fiscal year ending September 30, 1978, $10,100,000 for the fiscal year ending
September 30, 1979, and $11,100,000 for the fiscal year ending September 30,' 1980.
No part of the funds appropriated under this section may be used to construct
any research laboratories.

ANNUAL REPORT

Sec 29. The Administrator shall prepare and submit to the President and the
Congress on or before January 1, 1979, and on or before January 1 of each
succeeding year a comprehensive report on the administration of this Act during
the preceding fiscal year. Such report shall include —

(1) a list of the testing required under section 4 during the year for which
the report is made and an estimate of the costs incurred during such year by
the persons required to perform such tests ;

607

(2) the number of notices received during such year under section 5, the
number of such notices received during such year under such section for
chemical substances subject to a section 4 rule, and a summary of any action
taken during such year under section 5(g) ;

(3) a list of rules issued during such year under section 6;

(4) a list, with a brief statement of the issues, of completed or pending
judicial actions under this Act during such year ;

(5) a summary of major problems encountered in the administration of
this Act; and

(6) such recommendations for additional legislation as the Administrator
deems necessary to carry out the purposes of this Act.

EFFECTIVE DATE

Sec. 30. This Act shall take effect October 1, 1977.

The Chairman. Are there amendments to the remainder of the bill ?

AMENDMENTS OFFERED BY MR. MOORE

Mr. Moore. Mr. Chairman, I offer amendments.
The Clerk read as follows :

Amendments offered by Mr. Moore ; Page 210, after line 3, add the following
new section :

KULE REVIEW

Sec. 30 [Sec. 32, as passed], (a) Any rule prescribed pursuant to this Act by
the Administrator may by resolution of either House of Congress be disapproved,
in whole or in part, if such resolution of disapproval is adopted not later than the
end of the first period of 60 calendar days when Congress is in session (whether
or not continuous ) which period begins on the date such rule is finally adopted by
the Administrator, Secretary of the Treasury, or Secretary of Health, Education,
and Welfare, as the case may be. The authority which prescribes a rule pursuant
to this Act shall transmit such rule to each House of Congress immediately upon
its final adoption. Upon adoption of such a resolution of disapproval by either
House of Congress within such 60-day period, such rule, or part thereof, as the
case may be, shall cease to be in effect.

(b) Congressional inaction on or rejection of a resolution of disapproval of a
rule promulgation under this Act shall not be deemed an expression of approval
of such rule.

Redesignate the succeeding section accordingly.

Page 103, insert after the item in the table of contents relating to section 29
the following new item :

Sec 30. Rule Review.
Redesignate the succeeding item accordingly.

Mr. Moore. Mr. Chairman, I ask unanimous consent that the amend-
ments be considered en bloc.

The Chairman. Is there objection to the request of the gentleman
from Louisiana ?

There was no objection.

Mr. ^Ioore. Mr. Chairman, one of the biggest problems today in the
Federal Government operations is the massive regulatory power of
the bureaucracy. Let us not forget that regulations have the full force
and effect of law, and often go far beyond what we intend here in
Congress, in the act we passed under which the regulations may be
issued.

They are made by bureaucrats who are not elected and cannot even
be readily removed, as many of them are employees of independent
agencies and actually may well answer to no one, especially the people.

Our Government is an ingenuous one of checks and balances. We do

608

have checks and balances for the three branches of Government, and
we have had it for 200 years. But there has come upon us a fourth
branch of Government, one for which we do not have any checks and
balances. That fourth branch is the bureaucracy. We have no effective
way today to undo an undesirable regulation, as the court will not
touch a regulation if it is in fact legal. Congress itself is not going to
pass a law to reverse a regulation as it is far too cumbersome to over-
turn every undesirable or oppressive regulation.

The fourth branch we have today of the bureaucracy was not con-
templated by our Founding Fathers. Indeed, the first regulatory
agency that appeared in this country did so after this country was
well over 100 years old, in 1887, when the ICC was created. Today we
have over 105,000 Federal bureaucrats, according to the Office of
Management and Budget, cranking out regulations on every aspect of
our lives, at a cost, according to the 0MB, of $130 billion a year. But
far more important is the cost of our personal freedom infringed upon
by the issuance of every regulation. I point out to my colleagues that
this is being done without any effective checks or balances of this great
power of the rulemaking agencies. I point out to my colleagues that
this problem is not just going to go away. It is not one that we can sit
here and make speeches about and go home and say, "Yes, bureaucracy
is a terrible thing but there is nothing I can do about it." We can do
something here and now with the passage of this amendment.

In the last 15 years this Congress created 236 different rulemaking
agencies, while disbanding only 21. Today the number of agencies,
bureaucrats, rules and regulations are growing at an alarming rate.
This problem is becoming more acute. It is not going away. The people,
rightfully, want us to do something now to correct this imbalance of
power. It is a very real, a very legitimate campaign issue, which we
must address.

Some 10,000 people responded so far to my latCvSt questionnaire sent
out last month, and 80 percent of the people responding heartily sup-
port this proposal. They fear today the very real excessive and un-
checked power of regulatory agencies, they feel a loss of personal free-
dom and they feel a frustration, as they know that nothing is cur-
rently being done to check this power. As one of my constituents put
it, when he answered the questionnaire, "We often could live better
with the problem than we can with the Federal Government's solution
to it."

This amendment is not a cure-all solution, but it is a tool with which
we can begin to solve this problem. It will help check the imbalance of
power by giving either House of Congress at long last, as one of the
three lejjitimate branches of Government, a veto over any rule or reg-
ulation issued under this bill by the bureaucracy. It will begin to bring
into balance, this out-of -balance power of the bureaucracy.

This House during the 94th Congress has already eight times ac-
cented this same amendment to eight other bills. This House has not
reiected it once. I will also point out that this is very similar to the
Administrative Rulemaking Reform Act CH.R. 12048) which has been
reported from the Committee on the Judiciary, and is now pending
be^^ore the Committee on Rules, which we all hope will soon grant a
rule.

609

According to the Library of Congress, there are 19 other provisions
such as this that are currently existing in law, some going back as far
as 1946.

I feel very strongly that this amendment should be adopted, to give
protection the awesome powers of this bill and more importantly pro-
tection from the rulemaking powers of the bureaucracy. We must
protect our people from any further loss of personal freedom and
to bring into check this out-of-balance power.

Mr. EcKHARDT. Mr. Chairman, I rise in opposition to the amend-
ment.

Mr. Chairman, we are considering one of the most important issues
that has been rased here. I would like to say that if we should vote
favorably for this amendment, we would put into this bill precisely
the same provision that was the expressed reason and the only rea-
son for the veto of the Pesticide and Rodenticide Act by the Presi-
dent the other day.

There may be many Members who disagree with me with respect
to the desirability of attaching a yo-yo string to legislative authority.
I have always been against that, and in this respect I agree with the
President's objection in his veto message. Indeed the attachment of a
yo-yo string which may pull back authority by legislative veto has
exactly the opposite effect that many of my colleagues think it has.
It tends to make Congress grant more irresponsible authority be-
cause we feel we can pull it back when in fact we cannot.

But if Members believe in principle in this type of review, in this
type of mixing of legislative with executive authority, if Members
believe in this retention of a qualified power to change a law after
it is enacted, I believe they should nevertheless vote against this
amendment in this particular case, because this amendment requires
legislative review of every type of rule that is finally adopted by the
Administrator, by the Secretary of the Treasury, or by the Secretary
of the Department of Health, Education, and Welfare. This includes
a testing rule \mder which the only thing the Administrator has done
is to say that "This chemical poses a threat to humans or to the en-
vironment, and we think it ouglit to be tested", [section 4]

A chemical company that does not want to have it tested, a com-
pany that does not want to submit it to testing, then could come up to
Congress and lobby before Congress to reject the testing rule. Now,
are we not in a fine position to review the question of whether or
not testing should be had? And, of course, the EPA has authority
in some instances to say that "We want this kind of testing." Should
we come in and second-guess the agency and say that we want an-
other kind of testing?

The second review is with respect to a ban under section 6 if
ultimately a chemical is found to be dangerous such as PCB. We had
this argument, and nearly all the Members voted to ban PCB's legis-
latively after a given period of time. But would we permit some person
or some industry that thinks something similar to PCB's, like PBB's
I are not dangerous to come in and lobby before Congress to reverse a
; rule?

1 It seems to me that if we provide for a congressional veto in this
instance we are inviting every large chemical manufacturer in the

610

country to come in and ask us to veto an administrative act. Why.
should we encumber ourselves with this kind of provision ?

We have been talking here about little business. Who is going to have
the money to come up here and lobby for a change, for an ameliora-
tion, or for a removal of the limitation with respect to a chemical?
Is a little business going to have the money to do that ?

When we delegate authority, we ought to delegate it in restricted
fields, as we have done in this bill. When we are dealing with a ban,
we ought to give full due process, as we have done in this bill. When
we are considering prohibiting a person from putting a product that
he manufactures on the market, we should permit him to have the
opportunity of cross-examination; he should be allowed to cross-ex-
amine with respect to the rule, and we have done that here.

But let us not make this a political matter that can be later raised
by anyone who has the clout to change the legislative process,

Mr. Broyhill. Mr. Chairman, I ordinarily agree w ith amendments
that are similar to that offered by the gentleman from Louisiana (Mr.
Moore). In fact, I have cosponsored legislation which would require
the agencies to submit the rules which subject individuals to crimi-
nal penalties and to submit those rules and regulations to Congress
for a period of time for review.

However, Mr. Chairman, this amendment actually goes far beyond
the terms of that bill. Under this amendment, even nonsubstantial
rules, rules of just ordinary procedure of the agency to guide people
in their access to the agency, would be subject to this amendment.

I also would point out that there are some very technical rules
that are going to come about as a result of section 4. Particularly,
these are the rules of the agency which spell out what kind of tests
are going to be required on these various chemicals.

Mr. Chairman, I just do not think that the Congress has the ex-
pertise to be making these judgments on technical subjects like this.

Furthermore, Mr. Chairman, under this amendment there is no
guarantee that the Congress would act. There is no procedure spelled
out in this amendment that would require the consideration of these
rules by Congress. What I am saying, Mr. Chairman, is that, in con-
sidering the way in which this amendment is written, it is reasonable
to assume that all of the rules that would be submitted pursuant to
this amendment would lie in the committee; and no action will be
taken by the Congress. There is no procedure spelled out in this amend-
ment which gives the right to a Member to discharge a committee, for
example, from further consideration of that rule or regulation.

For these reasons, Mr. Chairman, I ask that this amendment be
rejected. Let us consider this subject in the bill which has been co-
sponsored by close to 200 Members, which I understand is now pend-
ing before the Committee on Rules; and let us consider this idea of
congressional review of rules and regulations in one bill under which
we can debate the merits of the legislation and not do it piecemeal
in this way.

Mr. Seiberling. Mr. Chairman, I would like to associate myself
with the remarks of the gentleman from North Carolina (Mr. Broy-
hill), as well as with the remarks of the gentleman from Texas (Mr.
Eckhardt).

611

It seems to me that this is an abdication of the legislative process
when we, on a blanket basis like this and without consideration of dis-
tinctions between different types of rules and rulemaking situations,
would have every one come back to the Congress. We would soon find
that we were utterly incapable of coping with the flood and would
have to triple the size of our committee staffs if we were to handle it
in a proper manner.

Mr. Broyhill. Mr. Chairman, let me comment. I do not personally
go all the way along with the argument of the gentleman from Ohio
(Mr. Seiberling). I am just speaking in opposition to this particular
amendment.

As I pointed out, Mr. Chairman, I have cosponsored legislation
which would apply to those rules which would subject the individual
to a criminal penalty. This amendment goes far beyond that. This
would apply to any rule.

Mr. Seiberling* Mr. Chairman, if the gentleman will yield further,
I thought that was a particularly good distinction which the gentle-
man from North Carolina (Mr. Broyhill) made, and I simply wanted
to commend him and associate myself with his remarks.

Mr. EcKHARDT. Mr. Chairman, I think one thing ought to be pointed
out : It was said that we never rejected these matters.

I think, as the gentleman has indicated, we need to consider them
individually. We have rejected such an amendment on the Coal Leas-
ing Act.

Each bill raises a different question and makes out a different case.
I think the gentleman has very clearly distinguished this case from
any of the others in which we have adopted such an amendment.

Mr. Martin. Mr. Chairman, I want to commend the gentleman from
Ix)uisiana (Mr. Moore) for his timely amendment, the arguments of
the gentleman from North Carolina (Mr. Broyhill) and the gentle-
man from Texas (Mr. Eckhardt) to the contrary notwithstanding.

Mr. Chairman, in 1771, over 200 years ago, a group of North Caro-
lina farmers, ironically calling themselves regulators, set out to oppose
excessive control by the King's agents. Today our people resent those
I people who are contemporary regulators. It is time, regardless of the
opinion of the executive branch, to limit our regulatory agencies, to
hold them accountable — in other words, to regulate the regulators.

Congress will respond under this amendment offered by the gentle-
,man from Louisiana (Mr. Moore) only where the cost of the regu-
ilators clearly exceeds the benefits.

It seems to me we would reserve the authority to make that judg-
ment. The executive branch should not be allowed to enlargfe its power
without being subject to elective authority. If we in the Congress are
indeed wise enouirh to judge the necessity to create such an agency as is
being proposed here today to regulate the chemical industry, it again
seems to me we should need the riglit to review those regulations and
reject them where they exceed our intent.

Mr. RoussELOT. Mr. Chairman, from some of the comments by my
colleagues who oppose this amendment they w^ould leave the impression
that Congress is mandated to review every single rule issued, and that
is not the case. We merely can take up the ones that our appropriate
committees think should be taken up, or that we feel are excessive. Is
that correct ?

612

Mr. Martin. That would be the way it would work out, I can assure
the gentleman from California.

Mr. RoussELOT. So that there is no demand that we absolutely take
up every new rule * * * it merely gives us a reviewing procedure. As
the gentleman from Louisiana (Mr. Moore) has wisely tried to provide j
in his amendment, it gives a veto capability to the Congress that we
have needed for some time. Because, unfortunately, so many of our reg-
ulatory agencies assume powers by implementing rules which we never
intended in original legislation.

I think this would be an excellent practice. I think that 60 days is
more than adequate time for our committees to take a hardnosed look at
many of these rules and regulations. ,

Again I compliment the gentleman from North Carolina (Mr.
Martin) and my colleague, the gentleman from Louisiana (Mr.
Moore). We have voted on this amendment many times although I i
have noticed that my colleague, the gentleman from Louisiana (Mr.
Moore) has very carefully worded this amendment to make sure that
it does not create any legal problems. I compliment both of my col-
leagues for offering this important amendment.

Mr. Martix. Mr. Chairman, I thank the gentleman for his observa-
tions. Over the past 15 years it has become the practice of Congress to I
create agency after agency and charging it to "Go ye forth into ye j
streets and do ye thing." These agencies have proceeded to do just that,
without restraint from any elected officials, and they themselves are not
elected and are not accountable for their actions. It is high time for j
such an amendment as this and other amendments that I have seen to ||
enable the Congress to reserve that authority to review the regulators I
and give them timely guidance. !

Mr. RoussELOT. I think the amendment is even more important be- j
cause this bill affects so many small chemical businesses. The rule- I
making power provided in this legislation is very substantial. It is j
important that the Congress give itself the chance to review this
rulemaking power.

Mr. Murphy of New York. Mr. Chairman, the President vetoed
earlier this month the Pesticide Control Act amendments because of
an amendment similar to that of the gentleman from Louisiana.

My colleague, the gentleman from Louisiana (Mr. Moore) has
offered his amendment in good faith and I can know and understand
the reason surrounding it. But I think the way to approach legislating
properly is the way we have done in this bill, and that is to get guide-
lines for the agency regarding the hearing process.

As a consequence, Mr. Chairman, I would ask that the committee
reject this amendment.

Mr. RoussEiX)T. Mr. Chairman, I would ask the gentleman from
New York, is there any great harm in the Congress taking the pre-
rogative of review? Does the gentleman see any great damage that
would be done to the congressional process for us to assume our respon-
sibilities of reviewing what agencies have done under the rulemaking
process ? Is that harmful ? 1

Mr. Murphy of New York. I think we have the resolution and the !
joint resolution route if we want to veto the Administrator's actions.
And we have oversight responsibilities. As the Members know, at the j
beginning of this Congress the majority caucus adopted a resolution

613

to broaden the oversight function of Congress for just the reason the
gentleman has stated.

Mr. RoussELOT. I am not suggesting that we should stop the con-
gressional oversight process. I think that is terribly important. But
related to that oversight process, we ought to make sure that agen-
cies do not engage in rulemaking that goes either beyond the legisla-
tive intent or maybe has not been properly thought out. Four hundred
thirty-five ^Members of this body hear from their constituents very
regularly on this problem of arbitrary rulemaking. They also hear
from those affected by legislation we pass. So is the gentleman really
agreeing with me that there is no great harm in this amendment ?

Mr. Murphy of New York. I would say the harm is this: This
Congress has worked 2 years, the previous Congress 2 years, and the
Congress before that 2 years, to try to bring out a Toxic Substances
Control Act to protect the health and the environment of Americans.
We can see that we can be vetoed after we have worked these 6 years
because of amendments such as this. I think to obviate that possibility
we have written the regulatory rules so that the Environmental Pro-
tection Administrator can bring forth proper rules. Accordingly I
would ask that the committee defeat the amendment.

The Chairman. The question is on the amendments offered by the
gentleman from Louisiana (Mr. Moore).

The question was taken ; and on a division (demanded by Mr. Moore)
there were — ayes 19, noes 41.

Mr. Moore. Mr. Chairman. I demand a recorded vote.

A recorded vote was ordered.

The vote was taken by electronic device, and there were — ayes 210,
noes 157, not voting 64, as follows :

[Roll No. 643]

AYES— 210

Alexander

Allen

Ambro

Andrews, N.C.

Andrews, N. Dak.

Archer

Armstrong

Ash brook

Bafalis

Baucus

Bauman

Beard. R.I.

Beard, Tenn.

Bell

Bennett

Bevill

Blaggri

Blanchard

Blouin

Boggs

Bowen

Breaiix

Breckinridge

Brinkley

Broomfield

Brown, Ohio

Buchanan
Bnrgener
Biirke. Fla.
Burke, Mass.
Burleson, Tex.
Butler
Carr

Cederberg
Clancy

Clausen, Don H.
Clawson. Del
Cleveland
Cochran
Cohen

Collins, Tex.

Cotter

Ooughlin

Crane

D'Amours

Daniel, Dan

Daniel, R. W.

Daniels, N.J.

Davis

Devine

Dickinson

Dodd

Downey, N.Y.

Downing. Va.

Duncan, Tenn.

Edgar

Emery

English

Erlenborn

Evans, Ind.

Findley

Fish

Pithian

Flowers

Flynt

Ford. Mich.

Fountain

Frenzel

Frey

Fuqua

Gaydos

Oilman

Ginn

Goldwater

Goodling

Gradison

Grassley

Guyer

614

Hagedorn

Lloyd, Tenn.

XV oe

HalGy

T .r^n or T ,Q

XvUUoll

Wall Til
rxdH, 111.

xiOusoeiOL

rliill, ±ex.

Lujan

Runnels

Hamilton

McDonald

Ruppe

Xidlllilltfl oLXilillUt

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irX JCi W c;Ll

OL VTcrixlalll

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ft Q T*Q G1 Tl
lk>dl dolll

xxdllbtrl

ividnon

odLterneiQ

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Xj.d.1 oXla

iud.rr.iii

ftoVlll 1 f70

ociiuize

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XTXclLllXo

fth»m

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HcfnGi*

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XTXdLollXLd^d

ftliiTiloir

Olll^lCj'

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fti tae

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opence

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A/Tttot*o Tti/1

ixxyuLo, xnu.

Vi T*n iri Ti
X mjL llLUll

"Nst f'oVioT

cL Lv.Xl\rX

Traxler

Ul/lltJo, i>I.V^.

X IcVll

XVCtoLtrll

Nedzi

VqiiHot' Tq cl"
T ciiiud uagi/

TJ'q von
xvd^trii

XCXlLllo

W^o oror/^rinoi*
TT dggVllUCX

Koll V

xvtJiiy

XJlXcll

TT dlOXl

O'Hara

TV dixi^x^x

iVtJLCllUlll

X dill

TT llltC

Keys

Pettis

Whitehurst

Kindness

Pickle

Whitten

Krebs

Pike

Wirth

Krueger

Poage

Wolf

LaFalce

Pressler

Wright

Lagomarsiuo

Pritchard

Wydler

Landrum

Quie

Wylie

Latta

Railsback

Young, Fla.

Lent

Regula

Young, Tex.

Levltas

Roberts

Siablocki

Lloyd, Calif.

Robinson

Zeferetti

NUKS — 157

Byron

Duncan Or<^£r

Annnnzio

Oarney

Early

Ashley

Carter

Eckhardt

Bedell

Clay

Edwards, Ala.

Rprdfliid

Collins, 111.

Edwards, Calif

Blester

Conable

Eilberg

Bingham

Conte

Evans, Colo.

Boland

Cornell

Fary

Bonker

Danielson

Fascell

Brademas

Delaney

Fenwick

Brodhead

Dellums

Fisher

Brooks

Dent

Flood

Broyhill

Derwinski

Florio

Burlison, Mo.

Diggs

Foley

Burton, John

Dingell

Ford, Tenn.

Burton, Phillip

Drinan

Forsythe

615

Fraser

Giaimo

Gibbons

Gonzalez

Gude

Harrington

Harris

Hawkins

Hayes, Ind.

Heckler, Mass.

Helstoski

Hicks

Holtzman

Horton

Howard

Jordan

Kastenmeier

Koch

Leggett

Long, Md.

McClory

McCloskey

McCollister

McCormack

McDade

McFall

McHugh

McKay

Madden

Maguire

Metcalfe

Meyner

Mezvinsky

Michel

Mikva

Miller, Calif.
Minish

Abdnor

Abzug

Adams

Anderson, Calif.

Anderson, 111.

Aspin

AuCoin

Badillo

Baldus

Boiling

Brown, Calif.

Brown, Mich.

Burke, Calif.

Chappell

Chisholm

Conlan

Conyers

Gorman

de la Garza

Derrick

du Pont

Esch

Mitchell, Md.

Moakley

Morgan

Mosher

Murphy, 111.

Murphy, N.Y.

Murtha

Myers, Pa.

Nix

Xolau

Nowak

Oberstar

Obey

O'Neill

Ottinger

Patten, N.J.

Patterson, Calif.

Pattison, N.Y.

Pepper

Perkins

Preyer

Price

Quillen

Rangel

Reuss

Rhodes

Richmond

Rinaldo

Rodino

Rogers

Rooney

Rose

Rosenthal

Rostenkowski

Roybal

Ryan

Sarbanes

NOT VOTING— (

Eshleman

Evins, Tenn.

Green

Hanley

Hays, Ohio

Hubert

Heinz

Henderson

Hinshaw

Holland

Holt

Howe

Jones. Ala.

Jones, Okla.

Jones, Tenn.

Karth

Lehman

Lundine

McKinuey

bleeds

Mink

Moorhead, Pa.

Scheuer

Schneebeli

Sebelius

Seiberling

Shriver

Simon

Skubitz

Slack

Smith, Nebr.
Solarz
Snellman
Staggers

Stanton, J. William
Stanton, James Y.
Stark

Steiger, Wis.
Stokes

Studds

Taylor, N.C.

Thompson

Thone

Tsongas

Udall

Ullman

Vander Veen

Vanik

Vigorito

Weaver

Whalen

Wiggins

Wilson, Bob

Wilson, Tex.

Winn

Yates

Yatron

Moss

Passman

Peyser

Randall

Rees

Riegle

Risenhoover

Roncalio

Russo

Santini

Sisk

Steel man
Steiger, Ariz.
Sullivan
Symington
Van Deerlin
Waxman
Wilson, C. H.
Young, Alaska
Young, Ga.

616

Mr. Hefner changed his vot€ from "no" to "aye."

So the amendments were agreed to.

The result of the vote was announced as above recorded.

AMENDMENT OFFERED BY MR. MAGUIRE

Mr. Maguire. Mr. Chairman, I offer an amendment.
The Clerk read as follows :

Amendment offered by Mr. Maguire: Page 208, insert after line 19 the
following :

STATE PROGRAMS

Sec. 28. (a) For the purpose of complementing (but not reducing) the authority
of, or actions taken by, the Administrator under this Act, the Administrator may
make grants to States for the establishment and oi>eration of programs to
prevent or eliminate unreasonable risks within the States to health or the
environment which are associated with a chemical substance or mixture and with
respect to which the Administrator is unable to take action under this Act for
their prevention or elimination. The amount of a grant under this subsection
shall be determined by the Administrator, except that no grant for any State
program may exceed 75 per centum of the establishment and operation costs
(as determined by the Administrator) of such program during the i)eriod for
which the grant is made.

(b) (1) No grant may be made under subsection (a) unless an application
therefor is submitted to and approved by the Administrator. Such anapplica-
tion shall be submitted in such form and manner as the Administrator may re-
quire and shall —

(A) set forth the need of the applicant for a grant under subsection (a),

( B ) identify the agency or agencies of the State which shall establish or
operate, or both, the program for which the application is submitted,

( C ) describe the actions proposed to be taken under such program,

(D) contain or be supported by assurances satisfactory to the Adminis-
trator that such program shall, to the extent feasible, be integrated with
other programs of the applicant for environmental and public health
protection,

(E) provide for the making of such reports and evaluations as the
Administrator may require, and

(F) contain such other information as the Administrator may prescribe.
(2) The Administrator may approve an application submitted in accordance

with paragraph (1) only if the applicant has established to the satisfaction of the
Administrator a priority need, as determined under rules of the Administrator,
for the grant for which the application has been submitted. Such rules shall take
into consideration the seriousness of the health effects in a State which are asso-
ciated with chemical substances or mixtures, including cancer, birth defects,
and gene mutations, the extent of the exposure in a State of human beings and
the environment to chemical substances and mixtures, and the extent to which
chemical substances and mixtures are manufactured, processed, used, and dis-
posed of in a State.

(c) Not later than six months after the end of each of the fiscal years 1979,
1980, and 1981, the Administrator shall submit to the Congress a report respect-
ing the programs assisted by grants under subsection (a) in the preceding fiscal
year and the extent to which the Administrator has disseminated information
respecting such programs.

(d) For the purpose of making grants under subsection (a) there are author-
i^AA^.^^^ appropriated $1,000,000 for the fiscal year ending September 30, 1978,
^1,000,000 for the fiscal year ending September 30, 1979, and $1,000,000 for the
fiscal year ending September 30, 1980. Sums appropriated under this subsection
shall remain available until expended.

Page 208, line 23, strike out "section 27'^ and insert in lieu thereof "sections 27
and Z8 .

Redesignate the succeeding sections accordingly.

Page 103, insert in the table of contents after the item relating to section 27
the following new item.

617

Sec. 28. State pro-ams.

Redesignate the succeeding items in the table of contents accordingly.

Mr. Maguire. Mr. Chairman, I support this landmark legisLation
and rise to otter an amendment which would provide financial assist-
ance to selected State to complement and augment the EPA efforts
authorized under this bill.

My amendment will give the Administrator of EPA the authority
to make grants to selected States, with severe problems related to toxic
chemicals, like Xew Jersey, to cover up to 75 percent of the costs of
establishing and operating programs to prevent or eliminate unreason-
able risks in the States to health or the environment associated with
chemical substances or mixtures. The grant money is earmarked for
use in ways which will complement the activities already underway or
being planned by f]PA for the implementation of this Act and for
activities which the Administrator is unable to undertake, because of
inadequate resources or other higher priorities. It is not intended to,
and will not replace, EPA's authority to require reporting, testing, or
any other of the authorities given in this act.

We have before us a formidable challenge — to take stock of the
chemical substances and mixtures now present in the environment
and to undertake, in an equitable manner, the task of determining
which substances may pose an unreasonable risk. It is a job so great
that the Federal (lovernment cannot be expected to liandle it alone.
The leadership in this effort properly belongs with the Federal Govern-
ment but the StatCvS too will play an important role in the process.

Under this amendment assistance for programs, in selected States
most heavily impacted by chemical pollution problems, will support
further innovation and expansion on tlie existing body of knowledge in
this field. The implications are significant for the chemical industr}^
and the Xation. Teamwork of State and Federal Governments in
tackling tlie problem of chemical pollution should ultimately prove
more efiicient for meeting the ])urposes of this act and could help to
minimize the burden on industry in submitting information and data
which will be required of them by this act.

This amendment gives the Administi-ator the authority to establish
rules for evaluating applications for grant assistance. These rules shall
take inro consideration three basic criteria for determining priority
need; first, the seriousness of health effects associated with chemical
substances and mixtures including cancer, birtli defects and gene
mutations; second", the extent of exposure of human beings and the
environment in a State to chemical substances and mixtures; and
third, the extent to which chemical substances and mixtures are manu-
factured, processed, used and disposed of within a State. By these
criteria we can be assui'ed that a State receiving this assistance has an
immediate need and tliat their experience in developing management
procedures and multimedia monitoring and inA'entorying procedures
will bolster P^PA's efforts in building a nationwide approach for
assessing the impact of chemical pollution on the public health and
the environment.

Concei-n has l)een expressed that this provision might represent a
"foot in the door" whereby the Environmental Protection Agency
might take advantage of the grant program to pass some of its testing.

79-313 O - 77 - 40

618

monitoring, and enforcement responsibilities on to State agencies.
This amendment has been carefully drafted to explicitly eliminate
such a possibility.

I have discussed my amendment with the floor manager Chairman
3,Iurphy, and with the majority and minority sponsors and I under-
stand that it is acceptable to them. I would like to add that a similar
amendment, sponsored by Senators Williams and Case was accepted
in the Senate version of the toxic substances bill.

^ly colleagues from Xew Jersey (Mi'. P^lorio and Mr. Rinaldo) join
me in urging that this amendment be unanimously adopted.

Mr. MuRriiY of Xew York. . . . I want to compliment my colleague,
the gentleman from Xew Jersey, on a well-thought-out amendment.
It does perfect the bill. Some States do have a concentration of chemi-
cal industry within the confines of those States. This amendment would
permit grants to be given to those States to protect themselves. I think
the amendment supplements the legislation, and I will agree to the
amendment.

Mr. Maguire. I thank the gentleman.

Mr. Broyhtll. ... I understand this is only a 3-year program as
envisioned in the bill ?

Mr. Maguire. That is correct. The amendment is for 3 years.

^fr. Broyiiill. For 3 years ?

]Mr. Maguire. Foi- 3 years ; that is correct.

Mr. Broyiiill. There are only 3 years of authorization; it is not an
unlimited authorization ?

Mr. ]\Ia(}1'ire. The gentleman is correct.

The (^iiAiRMAx. The question is on the amendment offered by the
gentleman from Xew eJersey (Mr. Maguire) . ^
Th(^ amendment was agreed to.

AMENDMENTS OFFERED BY MRS. FENW^K K

^Irs. Fen WICK. Mr. Chairman, I offer amendments.
The Clerk read as folloAvs :

Amendments offered by Mrs. Fenwick : Page 205, line 10. [Sec. 26(b)], after
"(b) Fees. — and insert "(1)".

Page 205, line 14. after "$2..500" insert "or, in the case of a small business
concern, any fee in excess of $100.00".

Page 205, after line 19, insert the following :

(2) The Administrator, after consultation with the Administrator of the Small
Business Administration, .^hall by rule prescribe standards for determining the
persons which qualify as small l)usiness concerns for purposes of this subsection.

Mrs. Fen WICK. Mr. Chairman, I ask unanimous consent that these
amendments be considered en bloc.

The Chairman. Is there objection to the request of the gentlewoman
from Xew Jersey ?

Thei'e was no objection.

^frs. Fenwick. Sir. Chaii'man, I will not take the time of the House.
These are small, simple amendments merely to make it possible for
small businesses for which the $2,500 fee is a very grave difficulty.
They are applied to persons required to submit data under sections 4
and 5 on request of the Administrator, and the $2,500 fee maximum is
impossible pai-ticularly if tliere is more tluin one substance to be tested.

619

Mr. McCoLLTSTER. ... I commend the cfontlewoman on her amend-
ments and siippoi't them.

^Irs. Fbxwick. I thank the gentleman.

Mr. MuRPiiY of New York. . . . The gentlewoman states the case
previously debated on protection for small business. It was inherent in
the committee's intent in this legislation. We thank her for clarifying
these amendments, and we will be happy to accept them.

Mrs. Fexwick. I thank the gentleman.

Ml-. Xoi^\x. I commend the gentlewoman for her amendments,
and urge their adoption.

Chaii-man. I rise in suppoit of the amendments. The S2,500
filing fee would work a severe hardship on suiall business enterprises
who manufacture chemicals.

Many small manufacturers thrive on limited-volume specialty prod-
ucts. These chemicals are often produced in quantities as small as
2,000 pounds per year. This compares with the thousands of tons which
some of the large manufacturers })roduce.

In addition, small companies often manufacture hundreds of these
limited-volume chemicals. One Midwest company, for example,
handles 1,0(M) difl'erent chemicals. Others produce an average of 200 or
300 chemical products. To impose repeated filing fees on these com-
panies is destructive, unfair and unnecessary.

Proponents of the bill proudly point to its endorsement by 186
manufacturers who produce 90 percent of our chemicals. This amend-
ment is designed to protect the 11,000 small businesses who produce the
other 10 percent. Du Pont with $.") billion in yearly sales or Union
Carbide with $3.5 can afford a $2,500 filing fee. But a small manufac-
turei- with a few million dollars in sales will not long survive a series
of hefty filing fees.

^Ir. Chairman, I believe these amendments are worthy of support
and I strongly urge my colleagues to adopt them.

Mrs. Ff.xwtck. I thank the gentleman also for his endorsement
and encouragement.

Mr. Maguirk. I commend the gentlewoman on her amendments.
My colleague, the gentlewoman from Xew Jersey, has improved the
bill in this respect, and I hope the amendments will be accepted.

Mrs. Fexwick. I thank my colleague for his comments.

The CiiAiR:\rAX. The question is on the amendments offered by the
gentlewoman from Xew Jersey (Mrs. Fenwick).

The amendments were agreed to.

AMEXDMEXT OFFERED BY ^IR. HECITLER OF WEST VIRGIXE\

Mr. Heciiler of West Virginia. ^Ir. Chairman, I offer an
amendment.

The Clerk read as follows :

Amendment offered b.v Mr. Hechler of West Virginia : On page 208, between
lines 19 and 20, insert tiie following new section:

"sunshine in G0\'ERNMENT

Sec. 28. [Sec. 29, as passed] (a) Each officer or employee of the Administrator
and the Secretary of Health. Edncation and Welfare who —

"(1) performs any function or duty under this Act; and

620

"(2) has any known financial interest (A) in any person subject to this
Act, or ( B ) in any person \Yho applies for or receives any grant, contract, or
other form of financial assistance pursuant to this Act ;
"shall beginning on -February 1, 1977, annually file with the Administrator or the
Secretary of Health, Education and Welfare, as appropriate, a written statement
concerning all such interests held by such officer or employee during the preceding
calendar year. Such statement shall be available to the public.
"(b) The Administrator and said Secretary shall —

"(1) act within ninety days after the date of enactment of this Act —

"(A) to define the term 'known financial interest' for purposes of
subsection (a) of this section; and

"(B) to establish the methods by which the requirement to file written
statements specified in subsection (a) of this section will be monitored
and enforced, including appropriate provisions for the filing by such
officers and employees of such statements and the review by the Admin-
istrator and said Secretary of such statements ; and
"(2) report to the Congress on June 1 of each calendar year with respect
to such disclosures and the actions taken in regard thereto during the
preceding calendar year.
"(c) lii the rules prescribed in subsection (b) of this section, the Administra-
tor and said Secretary may identify specific positions within the appropriate
agency which are of a nonregulatory or nonpolicymaking nature and provide
that officers or employees occupying such positions shall be exempt from the
requirements of this section.

"(d) Any officer or employee who is subject to, and knowingly violates, this
section or any regulation issued thereunder, shall be fined not more than $2,500
or imprisoned not more than one year, or both."
Renumbered the succeeding sections.

Mr. IIecitler of West Virginia. Mr. Chairman, I have a "Sunshine
in (Tovernnient'' amendment to H.R. 14032, as reported, at the desk
wliich is printed in the August 9, 1976 Record at page H8564. The
amendment adds a new section 28 and renumbers the present section
28 and succeeding sections.

Mr. Chairman, the purpose of this amendment is to bring more
sunshine into Government. It is the same provision ^vllich the Congress
adopted last December for the Federal Energy Administration and
some of tlie employees of the Interior Department administering
Public Law 94-163 — the Energy Policy and Conservation Act. On
Mav 20, 1976, the House adopted this provision for ERDxV employees
in H.R. 13350, which authorized appropriations for fiscal year 1977
for P]RI)A. Earlier this year, the House added it to H.R. 8560 for
employees of Interior administering the Outer Continental Shelf
leasing program and to H.R. 9560 for EPA employees administering
the water ]:)olluti()n program. The House also added it to H.R. 1377,
the public lands bill, for employees of Interior and to H.R. 13555, the
mine health and safety bill, for Interior, HEW, and Labor employees.
It was also added to H.R. 88401, the nuclear assurance bill, for ERDA
employees. In addition, it is included in H.R. 12112, as reported by
three committees, including the Interstate and Foreign Commerce
Committee, for ERDA employees and in H.R. 14496 for EPA
employees.

My amendment requires officers and employees of the agencies who
perform any function under the Toxic Substances Act to file annually
statements of any known financial interest in the persons subject to this
bill or who receive financial assistance under the bill. Such statements
would be available to the public and would have to be reviewed by
EPA. Positions witliin EPA that are of a nonregulatory or nonpolicy-

621

making nature could be exempted from this requirement by the
Administrator,

The amendment does not prevent any employee from having such
interests. It merely requires that they disclose such interests. It does
not apply to consultants.

Currently. EPA and other Federal agencies require their employees
who are at the GS-13 level or above and in a decisionmaking position
to file financial interest statements which are not available to the public.
This requirement is not based on any statutory provision but on a
1965 Executive Order Xo. 11222 and Civil Service Commission regula-
tions. But the Executive order and regulations do not have any teeth.
;My amendment does.

Moreover, in a series of reports on the effectiveness of the financial
disclosure system for agency employees, the GAO has found ''deficien-
cies'' in the system at Interior and several agencies, including in the
collection and timely review of such statements, and the resolution of
problems associated with the statements. In a March 3, 1975, report, the
GAO said:

Many USGS employees have financial interests which appear to conflict with
their Government duties. Many of these holdings viohite the Orjjanic Act of 1S79.
We believe that the ownership of these conflicting: interests is due to deficiencies
in the Department's financial disclosure system and that tliey will have to be
corrected to prevent the situation that now exists from continuing.

To improve he effectiveness of the USGS financial disclosure system, we recom-
mend that the Secretary of the Interior :

Review, and take remedial action on. the financial interests of T^SGS oflicials
which raise conflict of interest i>ossibilities or violate the Organic Act.

Prepare, keep current, and issue to USGS i>ersonnel specific guidelines, includ-
ing a list of prohibited securities, concerning financial interests which may violate
the Organic Act.

Require the Bureau Counselor to strictly adhere to the restrictions imposed on
USGS employees by the Organic Act.

Insure that adequately trained and experienced personnel, who are knowledge-
able of employees' duties and potential conflicts of interest, are appointed to
counsel employees and review financial disclosure statements.

Insure that oflScials responsible for reviewing financial disclosure statements
are given specific guidelines and reference manuals to enable them to adequately
evaluate the statements.

Require reviewing oflScers to sign and date the financial disclosure statements
to indicate they have reviewed them and determined that the financial interests
do not violate the Organic Act or raise conflict of interest possibilities.

Require the USGS Counselor to report the results of the annual financial dis-
closure review to the Department and to note any financial interests questioned
and any remedial action taken.

Establish procedures for i)eriodically reviewing financial disclosure statements
to insure that Bureau Counselors adequately enforce conflict of interest
regulations.

In a later report of December 1975. tlie GAO said that Interior was
taking steps to improve the situation but the GAO said there were
1.435 additional employees who should file statements, of wliich 1.100
were below the GS-13 level.

The GAO made similar findings in eight other studies since late
1974.

My amendment makes it clear that tlie Administrator of EPA must
periodically look at the positions to determine who should file and not
base his decision on the grade level of the employee. It also mandates
annual filing bv the affected employe and review by the agency and

622

provides criminal penalties for knowing violation. Adequate provision
is made for the Administrator to define what a "known financial inter-
est" is. Indeed, as example of such a definition, Interior published
proposed regulations defining this term on March 22, 1976, for the
purposes of Public Law 94-163. That definition, which is not jet
finalized, of course, is as follows :

Any pecuniary interest of which an oflacer or employee is cognizant or of which
he can reasonably be expected to have knowledge. This includes pecuniary interest
in any person engaged in the business of exioloring, developing, producing, refin-
ing, transporting by pipeline or distributing (other than at the retail level) coal,
natural gas, or petroleum products, or in proi)erty from which coal, natural gas,
or crude oil is commercially produced. This further includes the right to occupy
or use the aforesaid business or proi)erty, or to take any benefits therefrom based
upon a lease or rental agreement, or upon any formal or informal contract with a
person who has such an interest where the business arrangement from which the
benefit is derived or expected to be derived has been entered into between the
parties or their agents. With respect to officers or employees who are beneficiaries
of "blind trusts," the disclosure is required only of interests that are initially
committed to the blind trust, not of interests thereafter acquired of which the
employee or officer has no actual knowledge.

Finally, the regulations would be expected to make it clear that
public disclosure of financial statements shall be only for lawful
purposes. A violation of this requirement is subject to criminal
prosecution.

I urge adoption of my amendment.

Mr. Murphy of New York. Mr. Chairman, I think this is a worthy
and constructive amendment. It would certainly prevent conflicts of
interest or even allegations of conflicts of interest. The committee
would be happy to accept the amendment.

The Chairman. Tlie question is on the amendment offered by the
gentleman from West Virginia (Mr. Hechler).

The amendment was agreed to.

Mr. Dr:vTXE. Mr. Chairman. I rise in opposition to pending legisla-
tion. I would like to have the Members read and to pay attention to the
minority views which appear on page 139 of the report. I will not en-
large on them due to the lateness of the hour.

Also I would like to point out that the administration opposes this
legislation as it is now being considered. It objects to the requirements
for the premarket notification on all new chemical substances, the re-
porting requirements on substances prior to manufacture, and the bill's
unnecessarily broad definition for requiring testing of chemical
substances.

I might add further that the adoption of the Moore amendment a
few moments ago, which I voted for, makes the bill, in my opinion,
even more objectionable to the administration and I cannot predict
what the final outcome might be.

Mr, RoussELOT. Mr. Chairman, I rise in vigorous opposition to the
legislation H.E. 140e32, Toxic Substances Control Act. In my estima-
tion, this bill is nothing more than one more attempt to legislate
Utopia by an unrealistic and a reckless Conoress. The worthy inten-
tion of tile legislation is good — to protect the health and welfare of
the Nation's citizens. But when one considers that this goal is already
being accomplished by at least 27 different laws now on the books,
that the proposed new law could potentially run about 10,000 small
companies out of business, and that the bill may be unconstitutional.

623

one questions whether or not H.K. 14032 is really necessary. I think it
is not.

There are at least three reasons Avhy tbin bill sliould be soundly
defeated. First, the bill lias serious constitutional problems. Provisions
of this legislation — section 11 — provides for unconstitutional search
or entry without a warrant. A person can be subjected to fine and
imprisonment without trial by jury — section 16. This is a clear viola-
tion of the seventh amendment. Section 6 provides that the EPA
Administrator may prohibit the manufacture of new chemicals by
rulemaking procedures without due process, a violation of the 14th
amendment. On constitutional grounds alone, then, this bill should be
rejected.

Second, this bill would result in endless delay and would overload
regulatory agencies. Similar regulations covering the safety and effec-
tiveness of drugs currently are in effect in the Federal Drug Admin-
istration and have served to greatly burden the development and mar-
keting of new drugs and medicines. With passage of this bill, the same
type of testing could be required of all new chemicals. The EPA alone
could be forced by environmental groups to process at least 300 and
possibly over 1,000 new chemicals every year.

Third, it has been estimated that enactment of H.R. 14032 could
force as many as 10.000 small chemical manufacturers out of business.
It has pointed out today that the Toxic Substances Control Act is
being supported by the chemical industry. Wiile the Manufacturing
Chemists Association, representing 186 of the largest chemical com-
panies in the country, has come out in favor of this bill, the other
10,000 smaller companies involved in the chemical business, cannot
possibly comply. The costs associated with compliance with many of
. the restrictive testing measures — testing costs per product have been
estimated at between $50,000 and $800,000— would simply force them
out of business.

I For these reasons, ^Ir. Chairman. I ur^e my colleagues to vote down
I this unnecessary, costly, and unconstitutional piece of legislation.

AMENDMENT OFFERED BY MR. MURPHY OF NEW YORK

Mr. Murphy of Xew York. Mr. Chairman, I offer an amendment.
The Clerk read as follows:

Amendnient offered by Mr. Mnrphy of New York : Pajje 208, in line 23 [Sec. 28;
, Sec. 30 as passed], strike out '•$11,100,000" and insert in lien thereof ".$12,625.-
1 000" : iji line 24 strike cut -$10,100,000" and insert in lieu thereof "$lf).200.000" ;
and in line 25, strike out "$11,100,000" and insert in lieu thereof "$17,850,000".

' Mr. Murphy of New York. Mr. Chairman, my amendment increases
I the authorization levels contained in the legislation. The amendment
would increase the authorizations for the 1978 fiscal year from $11.1
million to $12,625,000. It would increase the 1979 authorization from
$10 million to $16.2 million, and it would increase the 1980 authoriza-
tion from $11.1 million to $17.35 million.

The authorizations presently in the bill were based upon estimates
• made when it was assumed the bill would become effective during the
1975 fiscal year. Time delays and the budget deadlines have resulted
in the effective date for the legislation being moved back to October
1977. As a result, anticipated inflation and increased costs of operation

624

make it necessary to increase the levels of authorizations of appropria-
tions for the first 3 years of operation under the bill.

The increased authorizations have been cleared by the Office of Man-
agement and Budget. The ranking minority members of our cojnmit-
tee support the increase.

There should be absolutely no inflationary impact upon the economy
as a result of this minor increase.

The need for the increased authorization is clearly demonstrated
if one compares the authorization levels contained in this bill with the
sums appropriated for administering other, similar programs. For
example, the Congress has appropriated $39 million for administra-
tion of the Federal Insecticide. Fungicide. Rodenticide Act. Over $147
million have been appropriated for carrying out the Clean Air Act.
and $422 million for operation of the Water Pollution Control
Act. As you can see, the sums authorized here are far below those for
any of these other similar programs. Even with the increased level of
authorization, we will be authorizing the bare minimum necessary for
effective implementation of this highly important legislation. I urge
my colleagues to support the amendment.

The Chairmax. The question is on the amendment offered by the
gentleman from New York (Mr. Murphy).

The amendment was agreed to.

AMENDMENT OFFERED BY MR. MURPHY OF NEW YORK

Mr. Murphy of Xew York. Mr. Chairman, I offer an amendment.
The Clerk read as follows :

Amendment offered by Mr. Mukphy of Xew York: Page 169 [Sec. 10], insert
"DEVELOPMENT," after "research," in line 14.

Viiiie 1()1). insert "development." after "research*' in lines 19 and 22.
Page 170, insert after line 26 tlie following :

(c) Screexixg Techniques. — The Administrator shall coordinate with the
Assistant Secretary for Health research undertaken by the Administrator and
directed toward the development of rapid, reliable, and economical screening
techniques for carcinogenic, mutagenic, teratogenic, and ecological effects of
chemical substances and mixtures.

(d) Monitoring.— The Administrator shall establish and be responsible for
research aimed at the development, in cooperation with local. State, and Federal
agencies, of monitoring techniques and instruments which may be used in the
detection of toxic chemical substances and mixtures and which are reliable,
economical, and capable of being implemented under a wide variety of conditions.

(e) Basic Research. — The Administrator shall establish research programs
to develop the fundamental scientific basis of the screening and monitoring tech-
niques described in subsections (c) and (d). the bounds of their reliability of
such techniques, and the opportunities for their improvement.

(f) Manpower Training. — The Administrator shall establish and promote
programs and workshops to train or facilitate the training of Federal laboratory
and technical personnel in existing or newly developed screening and monitoring
techniques.

(g) Exchange of Research and Development Results. — The Administrator
shall, in consultation with the Secretary of Health, Education, and Welfare and
other heads of appropriate agencies, establish and coordinate a system for ex-
cliange among Federal. State, and local authorities of research and development
results respecting toxic chemical substances and mixtures, including a system
to facilitate and promote the development of standard data format and analysis
and consistent testing procedures.

I'age 20S [Sec. 28], insert after "other than section 27" in line 23 the following:
•'and sub.sections (a) and (c) through (g) of section 10."

625

Mr. Murphy of Xew York. Mr. Chairman, this amendment is an
amendment that would have been offered by the gentleman from Cali-
fornia (Mr. Browx), who is the chairman of the Subcommittee on
Environment and the Atmosphere of the Committee on Science and
Technologj\

Mr. Chairman, this amendment provides additional guidance to
the Administrator regarding research and development work con-
ducted under the bill. It directs the Administrator to develo23 improved
monitoring techni(iues and instnnnents for the detection of toxic chem-
ical substances and mixtures. It also directs the Administrator to
establish and promote programs to train Federal laboratory and tech-
nical personnel in existing or newly developed chemical screening and
monitoring techniques. Because the authorization levels in this bill are
extremely low, the moneys to carry on this expanded research and
training program will come from authorization of appropriations
provided in the legislation originating in the Committee on Service
and Technology.

Mr. Chairman, this amendment provides constructive guidance and
direction to the Environmental Protection Administration in carry-
ing out research and related programs respecting toxic chemicals.

The subcommittee, chaired by the gentleman from California
(Mr. Brown), has invested considerable time and effort in reviewing
current EPA research and development activities. This amendment
would help overcome some of the short -comings which exist in the
present programs, and it should improve the research activities con-
ducted under the auspices of the toxic substances legislation.

Mr. Chairman, I would urge acceptance of the amendment.

Mr. McCoLLTSTER. Mr. Chairman, we have no objection to the
amendment.

Mr. Hfxhler of West Virginia. Mr. Chairman, as a member of the
Committee on Science and Technology. I strongly support this amend-
ment.

The Chairman. The question is on the amendment offered by the
gentleman from New York (Mr. Murphy).
The amendment was a<rreed to.

^Ir. Butler. Mr. Chairman, mv purpose in arising is to inquire
li the g(Mitleman from Xobraska (Mr. McCollister) if the gentleman
"an explain the effect of the preemption provision [Sec. 18] on the
ability of a State to meet local problems of great magnitude ; as for
example the Kepone problem, which is not a toxic substance, but one
\vhich illustrates a local problem that might arise. Will a State be fore-
:losed by this legislation from taking effective legislation on their
Dwn ?

Mr. McCollister. ]Mr. Chairman, the State law is preempted only
when the EPA has issued a rule under section 4, section 5 or section 6.

If the EPA has not acted, the States are free to act. If the EPA has
K'ted. then the States must apply for an exemption from the
preemption.

Before the State can put a different requirement into effect, it has
o ask for an exemption from the preemption.

This provision was designed to discourage differing State require-
nents which would put an undue burden on those companies that do
:)usiness in a number of States.

626

Mr. 'Butler. Mr. Chairman. I thank the gentleman. I judge that
in the absence of action by the EPA under section 4, 5, or 6. that the
States are free to take whatever action they deem appropriate under
the circumstances.

Mr. Broyiiill. Mr. Chairman, there is nothing in this act that affects
the right of States to act in their authority over disposal of hazardous
properties or hazardous chemicals, for that matter.

^rr. BrTL^:R. ^Ir. (^hairman, T recognize that and I appreciate the
gentleman's contribution.

The (^iiAiRMAx. If there are no further amendments, the question
is on the committee amendment in the nature of a substitute, as
amended.

The committee amendment in the nature of a substitute, as amended,
was agreed to.

The Chairman, l^ndei* the rule, the Committee rises.

Accordingly the Counnittee I'ose; and the Speaker having resumed
the chair, ]Mr. Mann, Chairman of the Committee of the Whole House
on the State of the Union, reported that that Committee having had
under consideration the bill (H.R. 14082) to regulate commerce and
protect health and the environment by requiring testing and necessary
restrictions on certain chemical substances and mixtures, and for other
purposes, pursuant to House Resolution 1458. he reported the bill back
to the House with an amendment adopted bv the Committee of the
Whole.

The Speaker. Under the rule, the previous question is ordered.

Is a separate vote demanded on any amendment to the committee
amendment in the nature of a substitute adopted by the Committee of
the Wliole ? If not. the question is on the amendment.

The amendment was agreed to.

The Speakp:r. The question is on the engrossment and third reading
of the bill.

The bill was ordered to be engrossed and read a third time, and was
read the third time.

MOTIOX TO RECOMMIT OFFERED BY MR. COLLIXS OF TEXAS

Mr. Collins of Texas. Mr. Speaker, I offer a motion to recommit.

The Speaker. Is the gentleman opposed to the bill ?

Mr. Collins of Texas. 1 am, ^Ir. Speaker.

The Speaker. The Clerk will report the motion to recommit.

The Clerk read as follows :

Mr. Collins of Texas moves to recommit the bill H.R. 14032 to the Committee
on Interstate and Foreign Commerce.

The Speaker. AVithout objection, the previous question is ordered on
the motion to recommit.
There was no objection.

The Speaker. The question is on the motion to recommit.

The motion to reconunit was rejected.

The Speaker. The question is on the passage of the bill.

The question was taken ; and the Speaker announced that the ayes
appeared to have it.

^Ir. Collins of Texas. Mr. Speaker.I object to the vote on the ground
that a (piorum is not present and make the point of order that a quorum
is not present.

627

The Speaker. Evidently a quorum is not present.
The Serfreant at Arms will notify absent Members.
The vot^ was taken by electronic device, and there were — yeas 319,
nays 45, not voting- 67, as follows :

[Roll No. 644]

YEAS— 319

Cotter

Gnver

AlpYfl nflpr

Coiiffhlin

AXcl^Ctlv^X 11

Allen

7~)' A Til fill

Haley

Anibro

Daiiipl n

Hall, 111.

Daniel R W

T-Tn 111 1 1 tnn

XXtllllllLi/ll

Dciiiit^ls X.J.

Hanley

A^ 1111V111£«1V7

Df\ iiipl ^^ri

C* 1 1 1 VT 1 0 V / 11

XX cl 11 11 tliUl CI

Ashley

Davis

XXd 1 IVlll

"Rn ffllisi

Delanev

xxd.1 1 iIlgLUU

AJCt HI- Uo

Dellunis

Harris

Tin nm fi n

Dent

TTq T*di 1
xxdl olid

Beard. R.I.

Derwinski

Hn wki rm

■XXC4. >> £\lXto

Bedell

Differs

XXd_\ t^!>, XIlU.

Bell

Dingell

xxtrviiurl , >> . ? cL,

Bpnnpf t

Dodd

T-TppItIpi* ATq CO

Rprp"! n n f1

Downey X.Y.

Hefner

Bevill

Do\yning, Va.

xxtris I UKi

Bio.^^i

Drinan

Hicks

Blester

Duncan, Or eg.

TT i P'Vi frt wpr
AAigiiLuw tri

Binglio.111

Duncan, Tenn.

Hillis

Rla Tiphfl rd

Early

XXUlldllU

Blouin

Eckhardt

XAK' 1. L^llldll

Edgar

T-T OT* frill

XXUl L till

Bolaiid

Edwards, Calif.

TTnwp rrl

XXi^ \> dl vl

Boiiker

Eilberg

TTn liliQ Trl
XX 11 i;iid 1 11

Bovveii

Emery

TTii o*h£»c
XX iiginr>

Bradenias

Erlenboru

TTn 11 (TO fci

XX UllgdtC:

Breaux

XX j> lie

Breokinridfii'p

Fary

Tn r>r»liw

Briiiklev

Eascell

«J trllUl IX!>

Tlr<»fUiPn f1

l^^pn wi r'L'

A V 11 W IL IV

Trkliiicrfcii r^*ili"f
ilUlllloUll, V cllll.

Brooks

Findlev

Brooiiifield

Fish

Tnrrl a 11
tJ Ul cid 11

ITi cVi£ki<

Kasten

Tli'nT^Vii 1 1

XJl liiii

I! iLuian

Kasteniueier

1 > llCllclllclll

Is.azen

X> Ul gclltrl

X" lUI 1()

Kenij)

Tliii'L'^j T^'^l o

XJlllKt^, X Id.

mir^Yi nTi"i

iveituuiii

Biirke, ^lass.

X Ijt ilL

Keys

Iv(K2h

Burton, John

X oru, iMicn.

Krebs

Ij xJx LI, X Crllll.

Ivrueger

Butler

Forsythe

La Fa Ice

Byron

Fountain

Lagomarsino

Carney

Eraser

Landrum

Carr

Frenzel

Latta

Carter

Frey

Leggett

Clancy

Fuqua

Lent

Clausen, Don H.

Gaydos

Leyitas

Clay

Giaimo

Lloyd, Calif.

Cleveland

Gibbons

Lloyd, Tenn.

Cochran

Gilman

Long, La.

Cohen

Ginn

Long, Md.

Collins, 111.

Gonzalez

Lott

Conable

Goodling

Lujan

Conte

Gradison

McClory

Cornell

Gude

McCloskey

628

McCollister

McCormack

McDade

McEweii

McFall

McHugh

McKay

Madden

Madigaii

Maguire

Mahon

Mann

Martin

Ma this

Matsunaga

Mazzoli

Melcher

Metcalfe

Meyner

Mezvinsky

Michel

Mikva

Milford

Miller, Calif.

Miller, Ohio

Mills

Mineta

Minish

Mitchell, Md.

Mitchell, N.Y.

Moakley

Moffett

Mollohan

Moore

Morgan

Mosher

Mottl

Murphy. 111.

Murphy, N.Y.

Murtha

Myers, Pa.

Natcher

Neal

Xedzi

Nichols

Nix

Nolan

Nowak

Oberstar

O'Brien

Archer

Armstrong

Ashbrook

Beard. Tenn.

Cederberg

Clawson, Del.

Collins, Tex.

Crane

Devine

Dickinson

Edwards, Ala

English

Evans, Ind.

Gold water

Grassley

O'Hara

O'Neill

Patten, N.J.

Patterson, Calif.

Pattison, N.Y.

Pepper

Perkins

Pettis

Pickle

Pike

Poage

Pressler

Preyer

Price

Pritchard

Quie

Quillen

Railsback

Rangel

Regula

Reuss

Richmond

Rinaldo

Roberts

Robinson

Rodino

Roe

Rogers

Rooney

Rose

Rosenthal

Rostenkowski

Roush

Roybal

Ruppe

Ryan

St Germain

Sarasin

Sarbanes

Satterfield

Scheuer

Schroder

Schulze

Seiberling

Sharp

Sh river

Sikes

Simon

Slack

Smith, Nebr.

Nays — 45

Hall, Tex.

Hammerschmidt

Hansen

Hutchinson

Ichord

J arm an

.Ten ret te

Johnson, Colo,

.Tohn.son, Pa.

Kelly

Kindness

McDonald

Montgomery

Moorhead, Calif.

Myers, Ind.

Snyder
Solarz
Spellman
Staggers

Stanton, J. Willia
Stanton, James V
Stark
Steed

Steiger, Wis.

Stephens

Stokes

Stratton

Studds

Talcott

Taylor, N.C.

Teague

Thompson

Thone

Thornton

Treen

Tsongas

Udall

Ullman

Vander Veen

Vanik

Vigorito

Walsh

Wampler

Weaver

Whalen

White

Whitehurst

Whitten

Wlison, Bob

Wilson, C. H.

Wilson, Tex.

Winn

Wirth

Wolff

Wright

Wydler

Wylie

Yates

Yatron

Young, Fla.

Young, Tex,

Zablocki

Zeferetti

Paul

Rhodes

Rousselot

Runnels

Schneebeli

Sebelius

Shipley

Shuster

Smith, Iowa

Stuckey

Symnis

Taylor, Mo,

Traxler

Waggonuer

Wiggins

629

Not Voting — 67

Abdnor

Eshleman

Passman

Abziijj

Evins, Tenn.

Peyser

Adams

Green

Randall

Anderson. Calif.

Hays, Ohio

Rees

Anderson, 111.

Hebert

Riegle

Aspin

Heinz

Ri.senhoover

AuCoin

Henderson

Roncalio

Badillo

Hinshaw

Russo

Baldus

Holt

Santini

Bollinjr

Howe

Sisk

Brown, Calif.

Jones, Ala.

Skubitz

Brown, Mich.

Jone.s, Okla.

Spence

Burke, Calif.

Jones, Tenn.

Steel man

Burleson, Tex.

Karth

Steiger, Ariz.

Chapiiell

Lehman

Sullivan

Chisholni

Lundine

Symington

Conlan

McKinney

Van Deerlin

Conyers

Meeds

Vander Jagt

Corman

Mink

Waxman

de la Garza

Moorhead, Pa.

Young, Alaska

Derrick

Mo.ss

Young, Ga.

du Pont

Obey

Esch

Ottinger

So the bill was passed.

The result of the vote was announced as above i-ecorded.
A motion to reconsider was laid on the table.

:\rOTIOX OFFERED BY INfR. STAGGERS

Mr. Staggers. Mr. Speaker, pursuant to the provisions of House
Resolution 1458. I move that Connnittee on Interstate and Foreio^n
Commerce be dischartred from the further consideration of the Senate
bill (S. 8140) to regulate commerce and protect human health and
the environment by requirin^r testing- and necessary use restrictions
on certain chemical substances, and for other purposes.

The Clerk read the title of the Senate bill.

The Speaker pro tempore. The question is on the motion offered
by the frentleman from "West Viro^inia (Mr. Sta^r^iei's) .
The motion was agreed to.

MOTTOX offered BY ^klR. STAGGERS

Mr. Staggers. Mr. Speaker, I offer a motion.
The Clerk read as follows :

Mr. Staggers moves to strike out all after the enacting clause of the Senate
bill S. 3149 and to insert in lieu thereof the provisions of H.R. 14032, as passed,
as follows :

SHORT TITLE

Section 1. This Act may be cited as the "Toxic Substances Control Act".

TABLE OF contexts

Sec. 1. Short title.

Sec. 2. Findings, policy, and intent.

Sec. .S. Definitions.

Sec. 4. Testinjr of chemical substances and mixtures.
Sec. o. Manufacturinjr and ))rocessing notices.

Sec. G. Regulation of hazardous chemical substances and mixtures.
Sec. 7. Imminent hazards.

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Sec. 8. Reporting and retention of information.
Sec. 9. Relationship to otlier Federal laws.

Sec. 10. Research, collection, dissemination, and utilization of data.
Sec. 11. Inspections.
Sec. 12. Exports.

Sec. 13. Entry into customs territory of the United States.
Sec. 14. Disclosure of data.
S^c. 15. Prohibited acts.
Sec. 16. Penalties.

Sec. 17. Specific enforcement and seizure.

Sec. 18. Preemption.

Sec. 19. Judicial review.

Sec. 20. Citizens' civil actions.

Sec. 21. Citizens' petitions.

Sec. 22. National defense waiver.

Sec. 23. Employee protection.

Sec. 24. Employment effects.

Sec. 2.1. Studies.

Sec. 26. Administration of Act.

Sec. 27. Development and evaluation of test methods.

Sec. 28. State proj?rams.

Sec. 29. Sunshine in government.

Sec. 30. Authorization for appropriations.

Sec. 31. Annual report.

Sec. 32. Rule review.

Sec. 33. Effective date.

FINDINGS, POLICY, AND INTENT

Sec. 2. (a) Findings. — The Congress finds that —

(1) humans and the environment are being exposed to a large number
of chemical substances and mixtures each year ;

(2) among the many chemical substances and mixtures constantly being
developed and produced are some w^hose manufacture, processing, distribu-
tion in commerce, use, or disposal may cause or significantly contribute to an
unreasonable risk to health or the environment ; and

(3) the effective regulation of interstate commerce in such chemical sub-
stances and mixtures also necessitates the regulation of intrastate com-
merce in such chemical substances and mixtures.

(b) Policy. — It is the policy of the United States that —

(3) authority over chemical substances and mixtures should be exercised
in such a manner as not unduly to impede, or to create unnecessary eco-
nomic barriers to, technological innovation while fulfilling the primary
purpose of this Act to assure that such innovation and commerce in such
chemical substances and mixtures do not cause or significantly contribute
to an unreasonable risk to health or the environment.

definitions

Sec. 3. As used in this Act :

(1) The term "Administrator" means the Administrator of the Environ-
mental Protection Agency.

(2) (A) Except as provided in subparagraph (B), the term "chemical sub-
stance" means —

(ii) any element or imcombined radical.
(B) Such term does not include —

(i) any mixture.

631

(ii) any pesticide (as defined in the Federal Insecticide, Fungicide, and
Rodenticide Act) when manufactured, processed, or distributed in com-
merce for use as a pesticide,

(iii) tobacco or any tobacco product,

(iv) any source material, special nuclear material, or byproduct mate-
rial (as such terms are defined in the Atomic Energy Act of 1954 and reg-
ulations issued under such Act),

(v) any article the sale of which is subject to the tax imposed by sec-
tion 4181 of the Internal Revenue Code of 1954 (determined without re-
gard to any exemptions from such tax provided by section 4182 or 4221 or
any other provision of such Code), and

(vi) any food, food additive, drug, cosmetic, or device (as such terms
are defined in section 201 of the Federal Food, Drug, and Cosmetic Act)
when manufactured, processed, or distributed in commerce for use as a
food, food additive, drug, cosmetic, or device.

The term '"food" as used in clause (vi) of this subparagraph includes poultry and
poultry products (as defined in sections 4(e) and 4(f) of the Poultry Products
Inspection Act), meat and meat food products (as defined in section l(j) of
the Federal Meat Inspection Act), and eggs and egg products (as defined in
section 4 of the Egg Products Inspection Act).

(3) The term "commerce" means trade, traflBc, or transportation (A) between
a place in a State and any place outside of such State, or (B) which affects
trade, traflSc, or transportation described in clause (A).

(4) The term "distribute in commerce" or "distribution in commerce" when
used to describe an action taken with respect to a chemical substance or mix-
ture or article containing a substance 'or mixture means to sell, or the sale of,
the substance, mixture, or article in commerce ; to introduce or deliver for in-
troduction into commerce, or the introducing or delivery for introduction into
commerce of, the substance, mixture, or article ; or to hold, or the holding
of, the substance, mixture, or article after its introduction into commerce.

(5) The term "environment" includes water, air, and land and the inter-
relationship which exist among and between water, air, and land and all living
things.

(6) The term "health and safety study" means any study of any effect of a
chemical substance or mixture on health or the environment, including epidemio-
logical studies, studies of occupational exposure to a chemical substance or
mixture, toxicological clinical, and ecological studies of a chemical substance
or mixture, and any test performed pursuant to this Act.

(7) The term "manufacture" means to import, produce, or manufacture.

(8) The term "mixture" means any combination of two or more chemical sub-
stances if the combination does not occur in nature and is not, in whole or in
part, the result of a chemical reaction; except that such term does include
a combination which occurs, in whole or in part, as a result of a chemical re-
action if each of the chemical substances comprising the combination is not a
new chemical substance and if the combination could have been manufactured
for commercial purposes without a chemical reaction at the time the chemical
substances comprising the combination were combined.

(9) The term "new chemical substance" means any chemical substance not
included in the chemical substance list complied and published under section
8(b).

(10) The term "process" means the preparation of a chemical substance or
mixture for distribution in commerce —

(A) in the same form or physical state, or in a different form or physical
state from that, in which it was received by the person making such prep-
aration, or

(B) as part of an article containing the chemical substance or mixture.

(11) The term "processor" means any person who processes a chemical sub-
stance or mixture.

(12) The term "standards for the development of test data" means a pre-
scription of —

(A) the-

(i) health and environmental effects, and

(ii) information relating to toxicity, persistence, and other char-
acteristics which affect health and the environment,

for which test data for a chemical substance or mixture are to be developed
any any analysis that is to be performed on such data, and

632

(B) to the extent necessary to assure that such data are reliable and
adequate, the manner in which such data are to be developed, the specifica-
tion of any test protocol or methodology to be employed in the development
of such data, and such other requirements as are necessary to provide such
assurance.

(13) The term "State" means any of the several States, the District of Co-
lumbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Canal
Zone. American Samoa, or the Trust Territory of the Pacific Islands.

(14) The term "United States", when used in the geographic sense, means
all the States.

TESTING OF CHEMICAL SUBSTANCES AND MIXTURES

Sec 4. (a) Testing Requirements. — If the Administrator finds that —

(1) (A) (i) the manufacture, distribution in commerce, processing, use,
or disposal of a chemical substance or mixture or any combination of ,such
actions may cause or significantly contribute to an unreasonable risk to
health or the environment,

(ii) there are insufficant data and exi>erience upon which the effects of
such manufacture, distribution in commerce, processing, use, or disposal
or combination of such actions on health or the environment can reasonably
be determined or predicted, and

(iii) testing of such substance 'or mixture with respect to such effects
is necessary to develop such data ; or

(ii) there are insuflScient data and experience upon which the effects
of the manufacture, distribution in commerce, processing, use, or disposal
of such substance or mixture or any combination of such actions on health
or the environment can reasonably be determined or predicted, and

(iii) testing of such substance or mixture with respect to such effects
is necessary to develop such data ; and

(2) in the case of a mixture, the effects which the mixture's manufacture
distribution in commerce, processing, use. or disposal or any combination
of such actions may have on health or the environment may not be rea-
sonably and more efficiently determined or predicted by testing the chemical
substances which comprise the mixture ;

the Administrator shall by rule require that testing be conducted on such sub-
stance or mixture to develop data with respect to the health and environmental
effects for which there is an insufficiency of data and experience and which are
relevant to a determination that the manufacture, distribution in commerce,
processing, use, or disposal of such substance or mixture or any combination
of such actions does or does not cause or significantly contribute to an unrea-
sonable risk to health or the environment.

(b)(1) Testing Requirement Rule. — A rule under subsection (a) requirinjx
the testing of a chemical substance or mixture shall include —

(A) identification of the substance or mixture for which testing is required.

(B) standards for the development of test data for sucli substance or mix-
ture, and

In determining the standards and period to be included, pursuant to subpara-
graphs (B) and (C). in a rule under subsection (a), the costs of the various
test protocols and methodologies which may be required under the rule and the
reasonably foreseeable availability of facilities and personnel for performing
testing under the rule. Such a rule may require the submission of preliminary data
during the period prescribed under subparagraph (C).

(2) (A) The health and environmental effects for whicli standards for the de-
velopment of test data may l)e prescril>ed include carcinogenesis, mutagenesis,
teratogenesis, be]la^^oral disorders, cumulative or synergistic effecrs. and any
other effect which may cause or significantly c()ntribute to an unreasonable risk
to health or the environment, and the cliaracteristics of chemical substances and

633

mixtures for which such standards may be prescribed include persistence, acute
toxicity, subacute toxicity, chronic toxicity, and any other characteristic which
may cause or significantly contribute to such a risk. The methodologies that ma.^
be prescribed in such standards include epidemiology, serial, or hierarchical tests :
in vitro tests : and whole animal tests. Before prescribing epidemiology rests in
such standards, the Administrator shall consult with the Director of the National
Institute for Occupational Safety and Health.

(B) From time to time, but not less than once each twelve months, the Ad-
ministrator shall review the adequacy of the standards for development «f data
prescribed in rules under subsection (a) and shall, if necessary, institute pro-
ceedings to make appropriate revisions of such standards.

(3) (A) A rule under sul)section (a ) respecting a chemical substance or mixture
shall require the persons described in subparagraph (B) to conduct tests and sub-
mit data on such substance or mixture, except that the Administrator may permit
two or more of such persons to designate one such person or a qualified third party
to conduct such tests and submit such data on behalf of the persons making the
designation.

(B) The following persons shall be required to conduct tests and submit data
on a chemical substance or mixture subject to a rule under subsection (a) :

(i) Each iierson who manufactures or intends to manufacture such sub-
stance or mixture if the Administrator makes a finding described in subsec-
tion (a) (1) (A) (ii) or (a) (1) (B) (ii » with resi^ect to the manufacture of
such substance or mixture.

(ii) Each i^erson who processes or intends to process such substance or mix-
ture if tlie Administrator makes a finding described in subsection (a) (1) (A)
(ii) or (a) (1) (B ) (ii> with resx)ect to the proces.sing of such substance or

mixture.

(iii) Eacli person who manufactures or processes or intends to manufac-
ture or process such substance or mixture for distribution in commerce if
with respect to the distribution in commerce of such sul)stance or mixture
the Administrator makes a finding describing in subsection (a)(l)fA)(ii»
or (a) (1) (R) (ii ).

(iv) Each ix'rson who manufactures or processes or intends to manufac-
ture or process such substance or mixture if with respect to the disiwsal of
such substance or mixture tlie Administrator makes a finding described in
subsection (a)(lMA)(ii) or (a) (1) (B) (ii).

(v) Each i>erson who manufactures or processes or intends to manufac-
ture or process such chemical substance or mixture for a use with respect to
which the Administrator makes a finding described in subsection (a) (1) (A)
(ii) or (a) (1 ) (B) (ii).

(4) A rule under subsection (a) requiring the testing of a chemical substance
or mixture shall expire at the end of the reimbursement period (as defined in
subsection (c)(3)(B)) applicable to test data for such substance or mixture,
unless the Administrator repeals the rule before such date.

(5) Rules issued under subsection (a) (and any amendment thereto or repeal
thereof) shall be promulgated pursuant to section 553 of title 5. United States
Code, except that in promulgating, amending, or repealing any such rule (A)
the Administrator shall give interested persons an opportimity for the oral pres-
entation of data, views, or arginnents. in addition to an opi>ortunity to make
written submissions: and (B) a transcript shall be made of any oral presenta-
tion. The Administrator may not promulgate a rule under subsection (a) resi>ect-
ing a substance or mixture unless the Administrator makes and publishes with
the rule the findings described in paragraph (1) (A) or (1)(B) of such sub-
section and. in the case of a rule respecting a mixture, the finding described in
paragraph (2) of such subsection.

(c) Exemption. — (1) Any i^erson required by a rule under suL)section (a) to
conduct tests and submit data on a chemical substance or mixture may apply to
the Administrator (in such form and manner as the Administrator shall pre-
scribe) for an exemption from such requirement.

(2) If. upon receipt of an application under paragraph (1). the Administrator
determines that —

(A) the chemical substance or mixture (including any contaminant present
in such substance or mixture) with respect to which such application was
submitted is equivalent to a chemical substance or mixture for which data
has been submitted to the Administrator in accordance with a rule under sub-
section ( a^ or for which data is being developed pursuant to such a rule, and

79-313 0 - 77 - 41

634

(B) submission of data by tlie applicant on such substance or mixture
would be duplicative of data which has been submitted to the Administrator
in accordance with such rule or which is being develoi>ed pursuant to such
rule,

the Administrator shall exempt, in accordance with paragraph (3) or (4), the
applicant from conducting tests and submitting data on such substance or
mixture.

(3) (A) If the exemption of any i^erson from the requirement to conduct tests
and submit test data on a chemical substance or mixture is granted on the basis
of the existence of previously submitted lest data and if such exemption is
granted during the reimbursement period for such test data (as prescribed by
subparagraph (B)), then (unless such person and the persons referred to in
clauses (i) and (ii) agree on the amount and method of reimbursement) the
Administrator shall order the person granted the exemption to provide fair and
equitable reimbursement (in an amount determined under rules of the
Administrator) —

(i) to the person who previously submitted such test data, for a portion
of the costs incurred by such person in complying with the requirement
to submit such data, and

(ii) to any other person who has been required under this subparagraph
to contribute with resi^ect to such costs, for a portion of the amount such
person was required to contribute.

In promulgating rules for the determination of fair and equitable reimburse-
ment to the persons described in clauses (i) and (ii) for costs incurred with
resi>ect to a chemical substance or mixture, the Administrator shall consider all
relevant factors, including the effect on the competitive position of the person
required to provide reimbursement in relation to the persons to be reimbursed
and the share of the market for such substance or mixture of the person re-
quired to provide reimbursement in relation to the share of such market of the
persons to be reimbursed. An order under this subparagraph shall, for purposes
of judicial review, be considered final agency action.

(B) For purposes of subparagraph (A), the reimbursement period for any
test data for a cliemical substance or mixture is a period —

(i) l)eginning on the date such data was submitted in accordance with
a rule promulgated under subsection (a), and

(ii) ending —

(I) five years after the date referred to in clause (i), or

(II) at the expiration of a period which begins on the date referred
to in clause (i) and is equal to the period which the Administrator
determines was necessary to develop such data,

whichever is later.

(4) (A) If the exemption of any person from the requirement to conduct tests
and submit test data on a chemical substance or mixture is granted on the basis
of the fact that test data is being developed by one or more persons pursuant
to a rule promulgated under subsection (a), then (unless such person and the
persons referred to in clauses (i) and (ii) agree on the amount and method of
reimbursement) the Administrator shall order the person granted the exemption
to provide fair and equitable reimbursement (in an amount determined under
rules by the Administrator) —

(i) to each such person who is developing such test data, for a portion
of the costs Incurred by each such person in complying with such rules, and

(ii) to any other person who has been required under this subparagraph
to contribute with respect to the costs of complying ^yith such rule, for a
portion of the amount such person was required to contribute.

In promulgating rules for the determination of fair and equitable reimbursement
to the ])ersons described in clauses (i) and (ii) for costs incurred with respect
to a chemical substance or mixture, the Administrator shall consider the factors
described in the second sentence of paragraph (3) (A). An order under this sub-
paragraph shall, for purposes of judicial review, be considered final agency
action.

(B) If an exemption is granted on the basis of the fact that one or. more
persons are developing test data jnirsuant to a rule promulgated under subsec-
tion (a) and if after such exemption is granted the Administrator determines
that no sucli person has complied with such rule, the Administrator shall (i)
after providing written notice to the i>erson who holds such exemption and an
opportunity for a hearing, by order terminate such exemption, and (ii) notify

635

in writing such person of the requirements of the rule ^yith respect to which
such exemption was granted. «iiilu
fd) Notice— Upon the receipt of any test data pursuant to a rule under
subsection (a), the Administrator shall, subject to section 14, promptly publisli

shall (1) Identify the chemical substance or mixture for which data have been
received: (2) list the uses or intended uses of such substance or mixture and
the information required by the applicable standards for the development of
test data; and (3) describe the nature of the test data developed. Except as
otherwise provided in section 14. such data shall be made available by the
Administrator for examination by any person.

(e) Priority List.— (1) (A) There is established a committee to make recom-
mendations to the Administrator respecting the chemical substances and mix-
tures to which the Administrator should give priority consideration for the
promulgation of a rule under subsection (a). In making such a recommendation
with respect to any chemical substance or mixture, the committee shall consider
all relevant factors, including —

(i) tlie quantities in which the substance or mixture is or will be
manufactured.

(ii) the quantities in which the substance or mixture enters the
environment.

(iii) the number of persons who will be exposed to the substance or mix-
ture in their places of employment and the duration of such exiwsure.

(iv) the extent of human exposure to the substance or mixture.

(V) the extent to which the substance or mixture is closely related to a
chemical substance or mixture which is known to cause or significantly
contribute to an unreasonable risk to health or the environment.

(vi) the existence of data concerning the effects of the substance or
mixture on health or the environment.

(vii) the extent to which testing of the sub.stance or mixture may result
in the development of data upon which the effects of the substance or mix-
ture on health or the environment can reasonably be determined or pre-
dicted, and

(viii) the reasonably foreseeable availability of facilities and personnel
for performing testing on the substance or mixture.

The recommendations of the committee shall be in the form of a list of
chemical substances and mixtures which shall be listed, either by indi-
vidual substance or mixture or by groups of substances or mixtures, in the
order in which the committee determines the Administrator should take
action under subsection (a) with respect to the substances and mixtures.

(B) Not later than twelve months after the effective date of this Act, the com-
mittee shall transmit to the Administrator the list required by subparagraph
(A) together with the reasons for the committee's inclusion of each chemical
substance or mixture on the lists. At least every six months after the trans-
mission to the Administrator of the list pursuant to the preceding sentence, the
committee shall make such revisions in the list as it determines to be necessary
and shall transmit them to the Administrator together with the committee's
reasons for the revisions. The Administrator shall make available to the public
the list transmitted by the committee, any revision by the committee in such
list (including the date on which such revision was transmitted to the Adminis-
trator), and the reasons of the committee for inclusion of a chemical substance
or mixture on the list and for any revision in the list. The Administrator shall
provide reasonable opportunity to any interested person to file with the Admin-
istrator written comments on the committee's list or any revision of the commit
tee of such list and shall make such comments available to the public.

(C) The Administrator may promulgate a rule under subsection (a) with
respect to a chemical substance or mixture which is not contained on a list
published under this subsection.

(2) (A) The committee established by paragraph (1) (A) shall consist of
eight members as follows :

(i) One member (or designee of the member) appointed from the Environ-
mental Protection Agency by the Administrator.

(ii) One member (or designee of the member) appointed by the Secretary
of Labor from oflicers of the Department of Labor engaged in the Secretary's
activities under the Occupational Safety and Health Act of 1970.

(iii) Oi\e member (or designee of the member) appointed from the Council
on Environmental Quality by the Chairman of the Council.

636

(iv) One member (or designee of the member) appointed from the Na-
tional Institute for Occupational Safety and Health by the Director of the
Institute,

(v) One member (or the designee of the member) appointed from the
National Institute of Environmental Health Sciences by the Director of the
Institute.

(vi) One member (or designee of the member) appointed from the Na-
tional Cancer Institute by the Director of the Institute.

(vii) One member (or designee of the member) appointed from the Na-
tional Science Foundation by the Director of the Foundation.

(viii) One member (or designee of the member) appointed from the
Department of Commerce by the Secretary of Commerce. A member may
designate an individual to serve on the member's behalf only with the ap-
proval of the applicable appointing authority and only if the individual is
from the entity from which the member was appointed. A vacancy in the
committee shall be filled in the same manner in which the original appoint-
ment was made.

(B) (i) The term of office of a member of the committee is four years, except
that of the members first appointed, four members shall have initial terms of
two years. Any member appointed to fill a vacancy occurring prior to the expira-
tion of the term for which the member's predecessor was appointed shall be
appointed only for the remainder of such term. If any member of the committee
leaves the office or entity from which the member was appointed, such member
may not continue as a member of the committee, and. for purposes of the pre-
ceding sentence, the member's position shall be considered as being vacant. A
member may serve after the expiration of the member's term of oflSce until
a successor has taken office.

(ii) Initial appointments to the committee shall be made not later than the
sixtieth day after the effective date of this Act. Not later than the ninetieth day
after such date the members of the committee shall hold a meeting for the selec-
tion of a chairman from among their number and to determine, by lot, the four
members who shall have initial terms of two years.

(C) The Administrator shall provide the committee such administratj,ve sup-
port services as may be necessary for the committee to carry out its function
under this subsection.

MANUFACTURING AND PBOCESSING NOTICES

Sec. f). (a) Notification for Manutactutie of Ne\v Chemical Substances. —
On and after the date on which the Administrator first publishes under section
S(b) a list of chemical substanc-es manufactured or processed in the United
States, no person may manufacture a new chemical substance unless (except as
provided in subsection (i) (relating to exemptions) ) such person —

(1) has. at least ninety days before such manufacture, submitted to the
Administrator, in accordance with subsection (f) (relating to notice con-
tent), a notice of such person's intention to manufacture such substance,
and

(2) has complied with any applicable requirement of subsection (d)
(relating to submission of test data).

(b) Notification for the Manufacture or Processing of a Chemical Sub-
stance for a Significant New Use. — (1) No person may manufacture or proc-
ess a chemical substance for a use which the Administrator has determined, in
accordance with paragraph (2), is a significant new use of such substance unless
(except as provided in subsection (i) ) such i)erson —

(A) has. at least ninety days before such manufacture or processing, sub-
mitted to the Admini.«Jtrator, in accordance with subsection (f), a notice of
such person's intention to manufacture or process such substance for such
use, and

(B) has complied with any applicable requirement of subsection (d).
(2) A determination by the Administrator that a new u.se of a chemical sub-
stance is a signific-ant new use with re.spect to which notification is required
under paragraph (1) or subsection (c)(1)(B) shall be made by a rule pro-
mulgated after a consideration of all relevant factors, including —

(A) the projected volume of manufacturing and processing of such sub-
stance for such use.

637

(B) the extent to which such use changes the tyi)e or form of exposure
of humans or the environment to such substance, and

(C) the extent to which such use increases the magnitude and duration
of exposure of humans or the environment to such substance.

The last sentence of section 19(c) (1) shall not apply to judicial review of any
rule promulgated under this paragraph.

(c) Notification for the Manufacture or Processing of Listed Chemical
Substances. — (1) (A) No person may manufacture a chemical substance —

(i) which is listed under paragraph (2) , and

(ii) which was a new chemical substance at the time of publication of
the earliest proposed rule under paragraph (2) listing such substance,

unless (except as provided in subsection (i)) such person has, at least ninety
days before such manufacture, submitted to the Administrator, in accordance
with subsection (f), a notice of such person's intention to manufacture such sub-
stance and has complied with the requirement of subsection (d).

(B) No person may manufacture of process a chemical substance, listed under
paragraph (2). for a use which the Administrator has determined, in accord-
ance with subsection (b) (2), is a significant new use of such substance unless
(except as provided in .subsection (i) ) such person —

(i) has, at least ninety days before such manufacture or processing, sub-
mitted to the Administrator, in accordance with subsection (f), a notice
of such person's intention to manufacture or process such substance for
such use, and

(ii) has complied with the requirement of subsection (d).

(2)(A)(i) Within twelve months after the effective date of this Act, the
Administrator shall, by rule, compile, and from time to time thereafter revise,
a list of chemical .substances the manufacture, processing, distribution in com-
merce, use, or disposal of which, or any combination of such actions resi^ecting
which, the Administrator finds causes or significantly contributes to or may
cause or significantly contribute to an unreasonable risk to health or the
environment.

( I ) the effects of the chemical substance on health and the magnitude
of human exposure to it ; and

(II) the effects of the chemical substance on the environment and the
magnitude of environmental exposure to it.

(B) The Administrator shall, in prescribing a rule under subparagraph (A)
which lists any chemical substance, identify those uses, if any, which the Ad-
ministrator determines, in accordance with subsection (b) (2), would constitute
a significant new use of such substance. The last sentence of .section 19(c)(1)
shall not apply to judical review of any provision of a rule under subparagraph
(A) which provision is prescribed pursuant to this subparagraph.

(C) Any ruie under subparagraph (A), and any amendemnt or repeal of
such a rule, shall be promulgated pursuant to the procedures specified in section
553 of title 5, United States Code, except that (i) the Administrator shall give
interested i)ersons an opiX)rtunity for the oral presentation of data, views, or
arguments, in addition to an opportunity to make written submissions, and (ii)
a transcript shall be kept of any oral presentation. The Administrator may not
promulgate under subparagraph (A) a rule listing a chemical substance unless
the Administrator makes and publishes with the rule the finding described in
such subparagraph.

(d) Requirement Respecting Submission of Test Data. — (1) (A) If —

(i) a person is required by subsection (a), (b), or (c) to submit a notice
to the Administrator before beginning the manufacture or processing of a
chemical substance, and

(ii) such i>erson is required to submit test data for such substance pur-
suant to a rule promulgated under section 4 before the submission of such
notice or such person has been granted an exemption under section 4(c)
from the requirement of such rule.

such person mav not, before the expiration of the period prescribed by subpara-
graph (B). manufacture such substance if the i^erson is subject to subsection

638

(a) or (c) (1)(A) or manufacture of process such substance for a significant
new use if the person is subject to subsection (b) or (c) (1) (B) .
(B) The period referred to in subparagraph (A) is —

(i) in the case of a person required to submit test data pursuant to a
rule promulgated under section 4(a) a period of ninety days which begins
on the date on which such person submits to the Administrator such data in
accordance with such rule, and

(ii) in the case of a person who under section 4(c) is exempt from a
requirement to submit test data pursuant to a rule promulgated under sec-
tion 4(a), a period of ninety days which begins on the date of the submis-
sion in accordance with such rule of the test data the submission or the
development of which was the basis for the exemption.

(2) (A) If—

(i) a person is required by subsection (c) to submit a notice to the Admin-
trator before, beginning the manufacture or processing of a chemical sub-
stance, and

(ii) (I) a rule promulgated under section 4 before the submission of such
notice requiring the submission of test data for such substance does not
require such i>erson to submit such data, or

(II) the Administrator has not promulgated such a rule for such sub-
stance before the submission of such notice,
such person may not, before the expiration of the ninety-day period which begins
on the date such person submits to the Administrator data prescribed by sub-
paragraph (B), manufacture such substance if such i)erson is subject to sub-
section (c) (1) (A) or manufacture or process such substance for a significant
new use if such person is subject to subsection (c) (1) (B) .

(B) Data submitted pursuant to subparagraph (A) shall be data which the
person submitting the data believes show that —

(i) in the case of a substance for which notice is required under subsection
(c) (1) (A), the manufacture, processing, distribution in commerce, use, and
disposal of the chemical substance or any combination of such actions
would not cause or significantly contribute to an unreasonable risk tOf health
or the environment, or

(ii) in the case of a chemical substance for which notice is required under
.subsection (c)(1)(B). the intended significant new use of the chemical
substance would not cause or significantly contribute to an unreasonable
risk to health or the environment.

(3) Data submitted under paragraph (1) or (2) shall be made available,
subject to section 14. for examination by interested persons.

(e) Extension of Notice Period. — The Administrator may for good cause ex-
tend for one additional period of not to exceed ninety days the period, prescribed
by subsection (a), (b). (c). or (d), before which the manufacturing or process-
ing of a chemical substance subject to such subsection may begin. Subject to
section 14. such an extension and the reasons therefor shall be published in the
Federal Register and shall constittue a final agency action subject to judicial
review.

(f) Content cf Notice; Publication in the Federal Register. — (1) The
notice required by subsections (a), (b), and (c) respecting a chemical substance
shall include —

(A) the name of the chemical substance ;

(B) the chemical identity and molecular structure of the substance, in-
sofar as such are reasonably ascertainable ;

(D) a reasonable estimate of the amount of the substance to be manu-
factured or processed and, insofar as reasonably ascertainable, a reasonable
estimate of the amount of the .substance to be manufactured or processed
for each proposed category of use of the substance ;

(E) a description of the byproducts, if any. resulting from the manufac-
ture, processing, use, or disposal of the substance, insofar as such are reason-
ably ascertainable ; and

(F) any test data in the possession or control of the person giving such
notice which are related to the effect on the health or the environment of any
manufacture, procc-^sing, distribution in commerce, use. or disposal of the sub-
stance or any article containing such substance.

639

Such a notice shall be made available, subject to section 14, for examination by
interested persons,

(2) Subject to section 14, not later than five days (excluding Saturdays, Sun-
days and legal holidays) after the date of the receipt of a notice under subsec-
tion (a), (b), or (c) or data under subsection (d) the Administrator shall pub-
lish in the Federal Register a notice which—

(A) identifies the chemical substance for which notice or data has been
received ;

( B ) lists the uses or intended uses of such substance ; and

(C) in the case of the receipt of data under subsection (d), describes the
nature of the tests performed on such substance and any data which was
developed pursuant to subsection (d) or a rule under section 4.

(g) Regulation Pending Development of Information. — (1) (A) The dis-
trict courts of the United States shall, upon application of the Administrator
made through attorneys of the p]nvir(mmental Protection Agency, have jurisdic-
tion to enjoin in ac'C<)rdance with subparagraph (B). the manufacture, processing,
or distribution in commerce of a chemical substance subject to a notification re-
quirement of sul)section (a), (b),or (c) if the court finds that —

(i) information available to the Administrator is insuflicient to permit a
reasoned evaluation of the effects on health or the environment of the manu-
facture, processing, distribution in commerce, use, or disposal of such chemi-
cal substance or any combination of such actions, and

(ii) in the absence of such information, the manufacture, processing, dis-
tribution in commerce, use, or disposal of such substance or any combina-
tion of such actions may cause or significantly contribute to an unreason-
able risk to health or the environment.

(B) An injunction issued under subparagraph (A) with respe^ct to a chemical
substance subject to a notification requirement under subsection (b) or (c)(1)
(B) respecting a significant new use of such substance shall apply <mly to the
manufacture, proce.ssing. or distribution in commerce, as the case may be, of the
substance for such use.

(i) upon the expiration of the five-day period beginning on the day after
the issuance of the injunction, if the Administrator does not within such
period publi.*^h the notice required by paragraph (2), or

(ii) if the Administrator publishes such notice within such period, upon
the completion or termination of the processing begun by publication of
such notice.

(2) (A) Within five days after the issuance of an injunction under paragraph
(1) with respect to a chemical substance, the Administrator shall publish, in
accordance with section 553(b) of title 5, United States Code, a general notice
of proposed rulemaking to begin proceedings for the promulgation of a rule to
applv to such substance one or more of the requirements described m section
6(a)' as is necessary to adequately protect against the risk to health or the en-
vironment found by the court under paragraph (1) (A) (ii). ^.i.-«„ci^

(B) Upon publication of such a notice the Administrator shall, as expeditiousiv
as possible, provide reasonable opportunity for a hearing (in '-^cc^rdance witn
paragraphs (2) and (3) of section 6(c) ) on such proposed rule, and either adopt
such rule (as proposed or with modifications) or by ^^f. P^^V^tho rn^P Tf
Federal Register terminate the proceeding for the Pronnilgation of the ruie ir
such a hearing is requested, the Administrator shall ^^^^fJ^^\^^'^^^^^^^^^
in fifteen days from the date such request is made unless ^^f f ^^^in strator^^^^^
each person making the request agree upon a later date the hea^^
and after the hearing is concluded the Administrator shall, withm thirty dajs
of the concilia of^the hearing, either adopt such rule as proposed or^^^^^
modifications) or terminate the proceeding (as prescribed in the preceding
sentence).

. 3 MV.r a rule promulCTted under pnrasrnph (2^ ha. '•'Vf rr^Za\''suoh
maV petition the Administrator to initiate a proceeding to amend or repeal sue
rule W thhi tl ittV "lavs ot the receipt of such a petition, the Administrator shall
hv orTer e thrgrant or deny the petition. If the Administrator f ™""^
etiHon the"wnfinistrator shall promptly initiate a proceeding for thhe amend-

640

ment or repeal, as the case may be, of such rule. Such a proceeding shall be con-
ducted in accordance with paragraphs (2) and (3) section 6(c).

(h) Petition for Standards for the Development of Test Data. — A person
intending to manufacture or process a chemical substance for which notice is
required under subsection (a), (b), or (c) and who is not required under a
rule under section 4 to conduct tests and submit data on such substance may
petition the Administrator to prescribe standards for the development of test
data for such substance. The Administrator shall either grant or deny any such
petition within sixty days of its receipt. If the petition is granted, the Adminis-
trator shall prescribe such standards for such substance within seventy-five
days of the date the petition is granted. If the petition is denied, the Administra-
tor shall publish in the Federal Register the reasons for such denial.

(i) Exemption. — (1) The Administrator may, upon application (made in
such form and manner as the Administrator may prescribe) exempt any person
from the requirement of subsection (a), (b), (c), or (d) or of any combination
of such subsections to enable such person to manufacture or process a chemical
substance for test marketing purposes —

(A) upon a showing by such person satisfactory to the Administrator
that the manufacture, processing, distribution in commerce, use and dis-
posal of such substance for such purposes would not cause or significantly
contribute to any unreasonable risk to health or the environment, and

(B) under such restrictions as the Administrator considers appropriate.
Within forty-five days of the receipt of an application under this paragraph
the Administrator shall either approve or deny such application.

(2) (A) The Administrator may upon application (made in such form and
manner as the Administrator may prescribe) exempt any person from the re-
quirement of subsection (d)(2) to submit data for a chemical substance. If,
upon receipt of an application under the preceding sentence, the Administrator
determines that —

(i) the chemical substance (including any contaminant present in such
substance) with respect to which such application was submitted is equiva-
Jent to a chemical substance for which data has been submitted to tj^e Ad-
ministrator in accordance with subsection (d) (2), and

(ii) submission of data by the applicant on such substance would be
duplicative of data which has been submitted to the Administrator in ac-
cordance with such subsection,

the Administrator shall exempt the applicant from submitting such data on
such substance. No exemption granted under this subparagraph with respect to
the submission of data for a chemical substance may take effect before the
beginning of the reimbursement period applicable to such data.

(B) If the Administrator, under subparagraph (A), exempts any person from
submitting under subsection (d)(2) data for a chemical substance because of
the existence of previously submitted data and if such exemption is granted
during the reimbursement period for such data, then (unless such person and
the persons referred to in clauses (i) and (ii) agree on the amount and method
of reiml)ursement) the Administrator shall order the person granted the exemp-
tion to provide fair and equitable reimbursement (in an amount determined
under rules of the Administrator) —

(i) to the person who previously submitted the data on which the exemp-
tion was l)ased. for a portion of the costs incurred by such person in com-
plying with the requirement under subsection (d) (2) to submit such data,

^"?ii ) to anv other person who has been required under this subparagraph
to contribute with respect to such costs, for a portion of the amount such
person was required to contribute. . , . ^ 4.

In promulgating rules for the determination of fair and equitable reimbursement
to the persons described in clauses (i) and (ii) for costs incurred with respect
to a chemical substance, the Administrator shall consider all relevant factors, in-
cluding the effect on tlie competitive position of the person required to provide
reimbursement in relation to the persons to be reimbursed and the share of the
market for such substance of the person required to provide rei mbur somen, m
relation to the share of such market of the persons to be reimbursed. An order
under this subparagraph shall be considered final agency action, for purposes ot

■ (C) For purposes of this paragraph, the reimlmrsement period for any pre-
viouslv submitted data for a chemical substance is a period—

641

(i) beginning on the date' of the termination of the prohibition, imposed
under this section, on. .the manufacture or processing of such substance by
the person who submitted such data to the Administrator, and

(ii) ending —

(I) five years after the date referred to in clause (i), or

(II) at the expiration of a period which begins on the date referred to
in clause (i) and is equal to the period which the Administrator deter-
mines was necessary to develop such data,

whichever is later.

(3) The requirements of subsections (a), (b), (c), and (d) do not apply with
respect to the manufacturing or processing of any chemical substance which is
manufactured or processed, or proposed to be manufactured or processed, only
in small quantities (as defined by the Administrator by rule) solely for —

(A) scientific experimentation or analysis or

(B) chemical research or analysis on such substance or another sub-
stance, including such research or analysis for the development of a product,

if all persons engaged in such experimentation, research, or analysis for a manu-
facturer or processor are notified (in such form and manner as the Administrator
may prescribe) of any risk to health which the manufacturer or processor has
reason to believe may be associated with such chemical substance.

(4) (A) The requirements of subsections (a) and (c) (1) (A) do not apply
with respect to the manufacturing or processing of any chemical substance
which is the same as a listed chemical substance.

(B) For purposes of subparagraph (A), a chemical substance shall not be
considered as different from a listed chemical substance solely because —

(ii) an inert listed chemical substance has been added to or deleted from
the chemical substance being compared.

(ii) the term "listed chemical substance" means a chemical substance in-
cluded in the list complied and published under section 8(b).

(5) The Administrator may, upon application, by rule exempt the manufac-
turer of anv new chemical substance from all or part of the requirements of this
section if the Administrator determines that such chemical substance will not
cause or significantly contribute to an unreasonable risk to health or the environ-
ment. A rule under this paragraph (and any substantive amendment to, or
repeal of. such a rule) shall be promulgated in accordance with paragraphs (2)
and (8) of section 6(c). ^ „ , „

(j) Defixitiqn.— For purposes of this section, the terms "manufacturer ana
"process" mean to manufacture or to process for commercial purposes.

REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND MIXTURES

Sec. 6. (a) Scope of Regulation.— If the Administrator finds that there is a
reasonable basis to conclude that the manufacture, processing, distribution in
commerce, use or disposal of a chemical substance or mixture or any comDi-
nation of such actions causes or significantly contributes to or will cause or
significantlv contribute to an unreasonable risk to health or the environment,
the Administrator shall by rule apply to such substance or mixture one or more
of the following requirements as is necessary to adequately protect against sucn

' (DA requirement prohibiting the manufacturing, processing, or distribu-
tion in commerce of such substance or mixture or limiting the amount ot
such substance on mixture which may be manufactured, processed, or dis-
tributed in commerce.
(2) \ requirement —

)a) prohibitinir the manufacture, processing, or distribution m com-
merce of such substance or mixture for (i) a particular use or ^n) a
particular use in a concentration in excess of a level specified by the
Administrator in the rule imposing the requirement, or

642

(B) limiting the amount of such substance or mixture which may be
manufactured, processed, or distributed in commerce for (i) a particu-
lar use or (ii) a particular use in a concentration in excess of a level
specified by the Administrator in the rule imposing the requirement.

(3) A requirement that such substance or mixture or any article con-
taining such substance or mixture be marked with or accompanied by clear
and adequate warnings and instructions with respect to its use or disposal
or with respect to both. The form and content of such warnings and instruc-
tions shall be prescribed by the Administrator.

(4) A requirement that manufacturers and processors of such substance
or mixture make and retain records of the processes used to manufacture
or process such substance or mixture.

(5) (A) A requirement regulating the manner or method of disposal of
such substance or mixture or article containing such substance or mixture
by its manufacturer or processor or any other person who uses it for com-
mercial purposes.

(B) A requirement under subparagraph (A) may not require any person
to take any action which would be in violation of any law or requirement
of or in effect for a State or political subdivision, and shall require each
person subject to it to notify each State and political subdivision in which a
required disposal may occur of such requirement.

(G) If the rule imposes on a chemical substance or mixture a requirement
described in paragraph (1) or (2), a requirement directing the manu-
facturer, processor, or distributor in commerce of such substance or
mixture or article containing such susbtance or mixture or directing
any combination of such i)ersons (A) to gave notice of such risk to
processors or distributors in commerce of such substance, mixture, or article,
or to both, and to the extent reasonably ascertainable to any other person
in possession of or exposed to such substance, mixture, or article; (B) to
give public notice of such risk ; or (C) to give both such notices.
A recpiirement imposed under this subsectian shall be the least burdensome re-
(piirement necessary to adequately protect against the risk with respect to which
the requirement was imiK)sed and may be limited in application to specified geo-
graphic areas.

(b) PROTECTIO^^ Against Adulteration or Contamination of Substances
Axi) Mixture. — If the Administrator has good cause to believe that a particular
manufacturer or processor is manufacturing or processing a chemical substance
or mixture in a manner which unintentionally causes the chemical substance or
mixture to cause or significantly contribute to or to be likely to cause or sig-
nificantly contribute to an unreasonable risk to health or the environment —

(1) the Administrator may by order require such manufacturer or proc-
essor to submit a description of the relevant quality control procedures
followed in the manufacturing or processing of such chemical substance or
mixture : and

(2) if the Administrator determines after the issuance of an order de-
scribed in paragraph (1) —

(B) that the use of such quality control procedures has resulted in
the distribution in commerce of chemical substances or mixtures which
cause or significantly contribute to an unreasonable risk to health or the
environment, the Administrator may order the manufacturer or proc-
essor to (i) give notice to such risk to processors or distributors in com-
merce of any such substance or mixture, or to both, and, to the extent
reasonably ascertainable, to any other person in i)os.session of or ex-
posed to any such substance, (ii) to give public notice of such risk, and
(iii) to provide such replacement or repurchase of any such substance
or mixture as is necessary to adequately protect health or the environ-
ment.

A determination under subparagraph (A) or (B) of paragraph (2) shall
be made on the record aftei- opportunity for hearing in accordance with
section 5.54 of title 5. Ignited States Code. The manufacturer or processor
subject to a requirement to replace or repurchase a chemical substance or

643

mixture may decide NA'hether to replace or repurchase the substance or
mixture and shall take either such action in the manner prescribed by the
Administrator.

(A) the effects of such substance or mixture on health and the magnitude
of human exposure to such substance or mixture,

(B) the effects of such substance or mixture on the environment and the
magnitude of environmental exposure to such substance or mixture,

(C) the benefits of such substance or mixture for various uses and the
availability of other substances or mixtures for such uses, and

(D) the reasonably ascertainable economic consequences of such rule
taking into account tbe impact on small business.

If the Administrator determines that a risk to health or the environment could
be eliminated or reduced to a suflficient extent by actions taken under another
Federal law (or laws) administered in whole or in part by the Administrator,
the Administrator may not promulgate a rule under subsection (a) to protect
against such risk unless the Administrator makes a finding that it is in the public
interest to protect against such risk under such rule taking into consideration
all aspects of the risk, the authorities under this Act and such other law (or
laws) to enforce actions taken under this Act or such law (or lavrs) to protect
against such risk, a comparison of the estimated costs of complying with actions
taken under this Act and under such law (or laws), and the relative efficiency of
actions under this Act and under such law (or laws). In the judicial review
of a rule under subsection (a) the last sentence of section 19(c)(1) shall not
apply witb respect to the determinations and findings required to be made by
this paragraph.

(2) (A) Rules under subsection (a) shall be promulgated pursuant to section
553 of title 5 of the United States Code ; except that in promulgating any such
rule (i) the Administrator shall give interested persons an opportunity for the
oral presentation of data, views, or arguments, in addition to an opportunity
to make written submissions: (ii) a transcript shall be kept of any oral presen-
tation; and (iir) during any such oral presentation, the Administrator shall in
elude an opportunity for cross-examination as provided in subparagraph (B).
The Administrator may not i)romulgate a rule under subsection (a) respecting
a chemical substance or mixture unless the Administrator makes and publishes
with the rule the finding described in such subsection. «

(B) An interested person is entitled, if the Administrator determines that it
is necessary to resolve disputed issues of material fact, to conduct or have con
ducted by the Administrator such cross-examination of persons as the Admin
istrator determines (i) to be appropriate in view of any need for expedition, the
nature of the is.'jues involved, and the number of participants and the nature of
their interests, and (ii) to be required for a full and true disclosure with re-
spect to such issues.

(C) (i) If the Administrator determines that a group of persons, each of whom
would but for this subparagraph be entitled to conduct (or have conducted)
cross-examination, has the same or similar interests in a proceeding, the Admin-
istrator may (I) conduct cross-examination on behalf of such group, or (II)
require such group to designate a sinsrle representative of such interests for pur-
poses of conducting cross-examination in such proceeding and such representa-
tive shall, except as provided in clause (ii), conduct such cross-examination.
If such group cannot asrrpe upon a single representative for such purposes, the
Administrator may limit the representation of such interests for such purposes.

(ii) When any person who is a member of a group with respect to which the
Administrator has made a determination under clause (i) is unable to agree
upon group representation with the oth^er members of the group, then such
person shall not be denied under the authority of such clause the opportunity
to conduct (or have conducted) cross-examination as to issues affecting the
person's particular interests if (I) the person satisfies the Administrator that
the person has made a reasonable and good faith effort to reach agreement upon
group representation with the other members of the group and (II) the Ad-

644

ministrator determines that there are substantial and relevant issues which are
not adequately presented by the group representative.

(D) The Administrator may issue procedural rules for the conduct of any oral
presentation (including cross-examination) under this paragraph and may im-
pose such reasonable time limits on each person's oral presentations authorized
by this paragraph as may be appropriate in view of any need for expedition, the
nature of the issues involved, and the number of participants and the nature of
their interests.

(E) In the judicial review of a rule under subsection (a) the last sentence
of section 19(c) (1) shall not apply to any determination of the Administrator
under this paragraph.

(3) (A) The Administrator may, pursuant to rules prescribed by it, i)rovide
compensation for reasonable attorneys' fees, expert witness fees, and other costs
of participating in a rulemaking proceeding for the promulgation of a rule under
subsection ( a ) to any person who represents an interest which will substantially
contribute to a fair determination of the issues to be resolved in the proceeding
taking into account the number and complexity of such issues and whether rep-
resentation of such interest will contribute to widespread public participation
in the proceeding and representation of a fair balance of interests for the resolu-
tion of such issues if —

(i) the economic interest of such person is small in comparison to the
costs of effective participation in the proceeding by such person, or

In determining whether compensation should be provided to a person under this
subparagraph and the amount of such compensation, the Administrator shall
take into account the financial burden whidi will be incurred by such person
in participating in the rulemaking proceeding.

(B) Tlie aggregate amount of compensation paid under this paragraph in any
fiscal year to all persons who, in rulemaking proceedings in which they receive
compensation, are persons who either —

(i ) would be regulated by the proposed rule, or

(ii) represent persons who would be so regulated, may not exceed 25 per
centum of the aggregate amount paid as compensation under this paragraph
to all persons in such fiscal year.

(4) Paragraphs (1), (2), and (3) of this subsection apply to the promulga-
tion of a rule rei>ealing, or making a substantive amendment to, a rule promul-
gated under subsection (a).

(d) ?]ffective Date. — (1) The Administrator shall specify in any rule under
subsection (a) the date on which it shall take effect, which date shall be as
soon as feasible.

(i) the Administrator determines that —

(I) the manufacture, processing, distribution in commerce, use. or
disposal of the chemical substance or mixture subject to such proposed
rule or any combination of such activities is likely to result in an un-
reasonable risk of serious or widespread harm to health or the environ-
ment before such effective date ; and

(II) making such proposed rule so effective is necessary to protect
the public interest ; and

(ii) in the case of a proposed rule to prohibit the manufacture, processing,
or distribution of a chemical substance or mixture because of the risk de-
termined under clause (i)(I), a court has in an action under section 7
granted relief with respect to such risk associated with such substance or
mixture.

645

Administrator and the person making the request agree upon a later date for
the hearing to begin, and after the hearing is concluded the Administrator shall,
within ten days of the conclusion of the hearing, either affirm such rule (as pro-
posed or with modifications) or revoke it.

(e) Poly chlorinated Biphenyls. — (1) within 6 months after the effective date
of this Act the Administrator shall initiate proceedings for the promulgation of
rules to —

(A) prescribe methods for the disposal of polychlorinated biphenyls, and

(B) require polychlorinated biphenyls to be marked with clear and ade-
quate warnings and instructions with respect to their processing, distribution
in commerce, use, or disposal or with respect to any combination of such
activities.

Requirements prescribed by rules under this paragraph shall be consistent with
the requirements prescribed by or under paragraphs (2) and (3).

(2) (A) Except as provided under subparagraph (B), effective one year after
the effective date of this Act no person may manufacture, process, or distribute in
commerce any polychlorinated biphenyl for any use other than a use in a totally
enclosed manner.

(B) The Administrator may by rule authorize the manufacture, processing,
or distribution in commerce (or any combination of such activities) of any poly-
chlorinated biphenyl for any use other than a use in a totally enclosed manner
if the Administrator tinds that such manufacture, processing, or distribution in
commerce (or combination of such activities) will not cause or significantly con-
tribute to an unreasonable risk to health or the environment.

(C) for the purposes of this paragraph, the term "totally enclosed manner"
means any manner which will ensure that any leakage of a polychlorinated bi-
phenyl from its enclosure will be insignificant as determined by the Administrator
by rule.

(3) (A) Except as provided in subparagraphs (B) and (C), effective two years
after the effective date of this Act no person may manufacture any polychlori-
nated biphenyl, and effective two and one-half years after such effective date
no person may process or distribute in commerce any polychlorinated biphenyl.

(B) Any interested person may petition the Administrator for an exemption
from the requirements of subparagraph (A) for a particular use of a polychlori-
nated biphenyl, and the Administrator may grant by rule such an exemption
the Administrator determines that —

(i) the exemptiou is necessary for the protection of the health or environ-
ment, and

(ii) good faith efforts have been made to develop a chemical substance
which may be sustituted for such polychlorinate<l biphenyl in such use and
which does not cau.«:e or significantly contribute to an unreasonable risk
to health or the environment.

An exemption granted under this subparagraph shall be subject to such terms
and conditions as the Administrator may prescribe and shall be in effect for
such period (but not more than one year from the date it is granted) as the
Administrator may prescribe.

(C) Subparagraph (A) shall not apply to the distribution in commerce of any
article containing any polycliiorinated biphenyi if such article was manufactured
before two and one-half years after the effective date of this Act.

(4) Any rule under paragraph (1), (2)(B), or (3) (B) shall be promulgated
in accordance with paragraphs (2) and (3) of sub.section (c).

IMMINENT HAZARDS

Sec. 7. (a) Actions Authorized and Required. — (1) The Administrator may
file an action in a district court of the United States —

(A) for seizure of an imminently hazardous chemical substance or mixture
or any article containing such a substance or mixture,

(B) for relief (as authorized by subsection (b)) against any person who
manufactures, processes, or distributes in commerce an imminently hazard-
ous chemical substance or mixture or any article containing such a sub-
stance or mixture, or

An action may be filed under this paragraph notwithstanding the existence of a
rule under section 4, 5, or 6, and notwithstanding the pendency of any adminis-
trative or judicial proceeding under any provision of this Act.

646

(2) If the Administrator has not made a rule under section 6(a) immediately
effective (as authorized by subsection 6(d) (2) (A) (i)) with respect to an im-
minently hazardous chemical substance or mixture, the Administrator shall file
in a district court of the United States with respect to such substance or mixture
or article containing such substance or mixture an action described in subpara-
graphs (A), (B), or (C) or paragraph (1).

(b) Jurisdiction of Court. — (1) The district court of the United States in
which an action under subsection (a) is brought shall have jurisdiction to grant
such temporary or permanent relief as may be necessary to protect health or
the environment from the unreasonable risk associated with the chemical sub-
stance, mixture, or article involved in such action.

(2) In the case of an action under subsection (a) brought against a person who
manufactures, processes, or distributes in commerce a chemical substance or
mixture or an article containing a chemical substance or mixture, the relief au-
thorized by paragraph (1) may include the issuance of a mandatory order requir-
ing (A) in the case of purchasers of such substance, mixture, or article known
to the de'^endant, notification to such purchasers of the risk associated with it ;
(B) public notice of such risk; (C) recall; (D) the replacement or repurchase
of such substance, mixture, or article; or (E) any combination of the actions
described in the preceding clauses.

(3) In the case of an action under subsection (a) against a chemical sub-
stance, mixture, or article, such substance, mixture, or article may be proceeded
against by process of libel for its seizure and condemnation. Proceedings in such
an action shall conform as nearly as possible to proceedings in rem in admiralty.

(c) Venue and Consolidation. — (1) (A) An action under subsection (a)
against a i^erson who manufactures, processes, or distributes a chemical sub-
stance or mixture or an article containing a chemical substance or mixture may
be brought in the United States District Court for the District of Columbia or for
any judicial district in which any of the defendants is found, resides, or transacts
business ; and" process in such an action may be served on a defendant in any
other district in which such defendant resides or may be found. An action under
subsection (a) against a chemical substance, mixture, or article may be brought
in any United States district court within the jurisdiction of which the substance,
mixture, or article is found.

(C) Subpenas requiring attendance of witnesses in an action brought under
subsection (a) may run into any judicial district.

(2) Whenever proceedings under subsection (a) involving identical chemical
substances, mixtures, or articles are pending in courts in two or more judicial
districts, they shall be consolidated for trial by order of any such court upon ap-
plication reasonably made by any party in interest, upon notice to all parties in
interest.

(d) Action T'nder Section 6. — ^Where appropriate, concurrently with the filing
of an action under subsection (a) or as soon thereafter as may be practicable, the
Administrator shall initiate a proceeding for the promulgation of a rule under
section 6(a).

(e) Representation. — Notwithstanding any other provision of law, in any ac-
tion under subsection (a), the iVdmini.strator may direct attorneys of the En-
vironmental Protection Agency to appear and represent the Administrator in

such an action.

(f) Definition. — ^^For purposes of subsection (a), the term "imminently haz-
ardous chemical substance or mixture" means a chemical substance or mixture
which cau.ses or significantly contributes to an imminent and unreasonable risk
of serious or widespread harm to health or the environment. Such a risk to health
or the environment shall be considered imminent if it is shown that the manu-
facture, processing, distribution in commerce, use, or disposal of the chemical
substance or mixture or any combination of such actions is likely to result in
such harm to health or the environment before a final rule under section 6 can
protect against such risk.

647

REPORTING AND RETENTION OF INFORMATION

Sec. 8. (a) Reports. — (1) The Administrator shall promulgate rules under
which —

(A) each person (other than a small manufacturer or processor) who
manufactures or processes or proposes to manufacture or process a chemical
substance (other than a chemical substance described in subparagraph (B)
(ii)) shall maintain such records, and shall submit to the Administrator
such reports, as the Administrator may i*easonably require, and

(B) each person (other than a small manufacturer or processor) who
ministrator by rule) solely for scientific-experimentation or analysis or

(i) a mixture, or

(ii) a chemical .substance in small quantities (as defined by the Ad-
ministrator by rule) solely for scientific-experimentation or analysis or
for chemical research or analysis on such substance or another sub-
stance, including such research or analysis for the development of a
product.

shall maintain records and submit to the Administrator reports but only to
the extent the Administrator determines the maintenance of records or sub-
mission of reports, or both, if necessary for the effective enforcement of this
Act.

The Administrator may not require in a rule promulgated under this paragraph
the maintenance of records or the submission of reports with respect to changes
in the proportions of the components of a mixture unless the Administrator finds
that the maintenance of such records or the submission of such reports, or both,
is necessary for the efi.iective enforcement of this Act. For purposes of the com-
pilation of tlie list of chemical substances required under subsection (b), the
Administrator sliall promulgate rules pursuant to this subsection not later than
one hundred and eigh'y days after the effective date of this Act.

(2) The Administrator may require under paragraph (1) reporting with
x-espect to the following :

(A) "J'he common or trade name, the chemical identity, and the molecular
structure of each chemical substance or mixture for which such a report is
required, insofar as known to the person making the rei>ort or insofar as
reasonably ascertainable.

(B) The categories or proposed categories of use of each such substance
or mixturi', insofar as known to the i)erson making the report or insofar as
reasonably ascertainable.

(C) Reasonable estimates of the amount of each substance and mixture to
be manufactured or processed and, insofar as known to the person making
the report or insofar as reasonably ascertainable, a reasonable estimate of
the amount of each such substance and mixture to be manufactured or proc-
essed for each of its categories or proposed categories of use.

(D) A description of the byproducts resulting from the manufacture,
processing, use, or disposal of each such substance or mixture, insofar as
known to the person making the report or insofar as reasonably ascertainable.

(E) All existing data concerning the adverse environmental and health
effects of such substance or mixture, insofar as known to the person making
the report.

(F) Estimates of the number of persons who wall be exposed to such sub-
stance or mixture in their places of employment and the duration of such
exposure, insofar as known to the person making the report.

To the extent feasible the Administration shall not require under paragraph (1)
unnecessary or duplicate reporting.

(3) (A)(i) The Administrator may by rule require a small manufacturer or
processor of a chemical substance to submit to the Administrator such informa-
tion resi)ecting the chemical substance as the Administrator may require for
publication of the first list of chemical substances required by subsection (b).

( ii ) The Administrator may by rule require a small manufacturer or processor
of a chemical substance or mixture —

(I) subject to a rule proposed or promulgated under section 4, 5(c). 5(g),
or. 6. or

(II) with respect to which relief has been granted pursuant to a civil
action brought under section 7, to maintain such records on such
substance, or mixture, and to submit to the Administrator such reports on

648

such substance or mixture, as the Administrator may reasonably require. A
rule under this clause requiring reporting may require reporting with respect
to the matters referred to in paragraph (2).
(B) The Administrator, after consultation with the Administrator of the
Small Business Administration, shall by rule prescribe standards for determining
the manufacturers and processors which qualify as small manufacturers and
processors for purposes of this paragraph and paragraph (1).

(b) IxvENTOKY. — (1) The Administrator shall compile, keep current, and pub-
lish a list of each chemical substance which is manufactured or processed in the
United States. Such list shall at least include each chemical substance which
any person reports, under section 5 or subsection (a) of this section, is manu-
factured or processed in the United States or was manufactured or processed
in the United States within three years before the effective date of the rules
promulgated pursuant to the last sentence of subsection (a) (1). In the case of
a chemical substance for which a notice is submitted in accordance with section
5, such chemical substance shall be included in such list as of the earliest date
(as determined by the Administrator) on which such substance was manufactured
or processed in the United States. The Administrator shall first publish such a
list not later than one year after the effective date of this Act. The Administrator
shall not include in such list any chemical substance which is manufactured or
processed only in small quantities (as defined by the Administrator by rule)
solely for scientific experimentation or analysis or for chemical reasearch or
analysis on such substance or another substance, including such research or
analysis for the development of a product.

(2) To the extent consistent with the puri>oses of this Act, the Administrator
may, in lieu of listing, pursuant to paragraph (1), a chemical substance individ-
ually, list a category of chemical substances in which such substance is included.

(1) records of adverse reactions to the health of employees be retained
for a period of not more than fifty years fr(mi the date such reactions were
first reported to or known by the person maintaining such records, and

(2) any other record be retained for a period of not more than five years
from the date the information contained in the record was first reported
to or known by the person maintaining the record.

Records required to be maintained under this subsection may include records of
consumer allegations of personal injury or harm to health, reports of occupa-
tional disease or injury, and reports or complaints of injury to the environment
submitted to the manufacturer, processor, or distributor in commerce by individ-
uals or governmental agencies. Ui)on request of an officer or employee duly
designated by the Administrator, each person who is required to maintain
records under this subsection shall permit the inspection of such records and
shall submit copies of such records.

(d) Health and Safety Studies. — The Administrator shall promulgate rules
under which the Administrator may require any i>erson who manufactures,
processes, or distributes in commerce or who proposes to manufacture, process,
or distribute in connnerce any chemical sub.stance or mixture (or with respect to
paragraph (2), any person who has possession of a study) to submit to the
Administrator —

(1) lists of health and safety studies conducted or initiated by or for such
person at any time or known to such person ; and

(2) copies of any such studies appearing on a list submitted pursuant to
paragraph (1) or (2), or otherwise known by such person.

(e) Notice to Administrator of Unreasonable Risks. — Any i^erson who
manufactures, processes, or distributes in commerce a chemical substance or
mixture and who obtains information which reasonably supi>orts the conclusion
that such substance or mixture causes or significantly contributes to a substan-
tial risk to health or the environment shall immediately inform the Administra-
tor of such information unless such person has actual knowledge that the Admin-
istrator has been adequately informed of such information.

(f ) Definitions. — For purposes of this section, the terms "manufacture" and
"process" mean manufacture or i)rocess for commercial purposes.

649

RELATIONSHIP TO OTHER FEDERAL LAWS

Sec. 9(a) Laws Not Administered by the Administrator. — (1) If the Admin-
istrator has reason to believe that tlie manufacture, processing, distribution in
commerce, use, or disposal of a chemical substance or mixture or any combina-
tion of such actions causes or significantly contributes to or is likely to cause
or significantly contribute to an unreasonable risk to health or the environment
and determines that such risk may be prevented or reduced to a sufficient extent
by action taken under a Federal law not administered by the Administrator, the
Administrator shall submit to the agency which administers such law a report
which describes such risk and includes in such description a specification of
the activity or combination of activities which the Administrator has reason to
believe so causes or contributes to such risk. Such report shall also request such
agency —

(A) (i) to determine if the risk described in such report may be prevented
or reduced to a suflScient extent by action taken under such law, and

(ii) if the agency determines that such risk may be so prevented or
reduced, to issue an order declaring whether or not the activity or combina-
tion of activities si)ecified in the description of such risk causes or sig-
nificantly contributes to such risk : and

(B) to report such determination and order to the Administrator.

Any report of the Administrator shall include a detailed statement of the infor-
mation on which it is based and shall be pul)lished in the P'ederal Register. The
agency receiving a request under such a report shall make the requested deter-
mination, issue the reciuested order, and make the requested report within such
time as the Administrator si)ecifies in the recpiest, but such time si>ecified may
not be less than ninety days from the date the request was made. The reiK)rt
of an agency in response to a request of the Administrator shall be accom-
panied by a detniled statement of the findings and conclusions of the agency
respecting the order and determination requested to be made and shall be pub-
lished in the Federal Regi.ster.

(2) If the Administrator makes a report under paragraph (1) with resi>ect
to a chemical substance or mixture and the agency to which such report was
made either —

(A) issues an order declaring that the activity or combination of activi-
ties specified in the description of the risk described in the report does not
cause or significantly contribute to the risk described in the report, or

(B) initiates, within ninety days of the publication in the Federal Register
of the report of the agency under paragraph (1) in resiK)nse to the Admin-
istrator's report, action under the law (or laws) administered by such
agency to protect against such risk,

the Administrator may not take any action under section 6 or 7 with respect to
such risk.

(3) If the Administrator has initiated action under secti<m 6 or 7 with respect
to a risk associated with a chemical substance or mixture which was the subject
of a report made to an agency under paragraph (1), .such agency shall before
taking action under the law ( or laws) administered by it to protect against such
ri.sk consult with the Admini.strator for the piTrpose of avoiding duplication of
Fefleral action against such risk.

(b) Laws Administered by the Administrator. — The Administrator shall
coordinate actions taken under this Act with actions taken under other Federal
laws administered in whole or in part by the Administrator. If a risk to health
or the environment associated with a chemical substance or mixture could be
eliminated or reduced to a sufficient extent by actions taken under the author-
ities contained in such other Federal laws, the Administrator shall use such
authorities to protect against such risk unless the Administrator determines that
it is in the public interest to protect against such risk by actions taken under
this Act. This sub.section shall not be construed to reUeve the Administrator of
any requirement imposed on the Administrator by such other Federal laws.

(c) AccrPATiONAL Safety and Health. — In exercising any authority under
this Act. the Administrator shall not. for purposes of section 4(b)(1) of the
Occupational Safety and Health Act of 1970. be deemed to be exercising statutory
authority to prescribe or enforce standards or regulations affecting occupational
safety and health.

(d) Coordination.— In administering this Act, the Administrator shall con-
sult and coordii^ate with the Secretary of Health. Education, and Welfare and

79-313 0 - 77 - 42

650

the heads of any other appropriate Federal executive department or agency,
any relevant independent regulatory agency, and any other appropriate in-
strumentality of the Federal Government for the purpose of achieving the
maximum enforcement of this Act while imposing the least burdens of dupli-
cative requirements on those subject to the Act and for other purposes. The
Administrator shall report annually to the Congress on actions taken to co-
ordinate with such other Federal departments, agencies, or instrumentalities,
and on actions taken to coordinate the authority under this Act with the
authority granted under other Acts referred to in subsection (b).

RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION, AND UTILIZATION OF DATA

Sec. 10. (a) Authority. — The Administrator shall, in consultation and co-
operation with the Secretary of Health, Education, and Welfare and with
other heads of appropriate departments and agencies, conduct such research,
development, and monitoring as is necessary to carry out the purposes of this
Act. The Administrator may enter iiito contracts and may make grants for
such re-search, d-^velopment, and monit< ring. C 'iitrMcts m -y be entered into
under this sul^seeUon withoi t regard to sections 3048 and 3709 of the Revised
Statutes (81 T'.S.C. 529, 41 U.S.C. T) ) .

(b) Data Systems. — (1) The Administrator shall establish, administer, and
be responsible for the continuing activities of an interagency committee which
will design, establish, and coordinate an efficient and effective system, within
the Environmental Protection Agency, for the collection, dissemination to other
Federal departments and agencies, and use of data submitted to the Adminis-
trator under this Act.

(2) (A) The Administrator shall, in consultation with the Secretary of
Health, Education, and Welfare and other lieads of appropriate departments
and agencies design, establish, and coordinate an efhcient and effective system
for the retrieval of toxicological and other scientific data which could be useful
to the Administrator in carrying out the purposes of this Act. Systematized re-
trieval shall be developed for use by all Federal and other departments and
agencies with responsibilities in the area of regulation or study of chemical
substances and mixtures and their effect on health or the environment.

(B) The Administrator, in consultation with the Secretary of Health, Educa-
tion, and Welfare, is authorized to make grants and enter into contracts for
the development of a data retrieval system described in subparagraph (A).
C'ontracts may be entered into under this subparagraph without regard to
sections 3(;4S and 3709 of the Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5).

(c) Screening Techniques. — The Administrator shall coordinate with the
Assistant Secretary for Health research undertaken by the Administrator and
directed toward the development of rapid, reliable, and economical screening
techniques for carcinogenic, mutagenic, teratogenic, and ecological effects of
chemical substances and mixtures.

(d) Monitoring. — The Administrator shall establish and be responsible for
research aimed at the development, in cooperation with local. State, and Fed-
eral agencies, of monitoring techniques and instruments which may be used in
the detection of toxic chemical substances and mixtures and which are reliable,
economical, and capable of being implemented under a wide variety of
conditions.

(e) Basic Research. — The Administrator shall establish research pro-
grams to develop the fundamental scientific basis of the screening and monitor-
ing techniques described in subsections (c) and (d), the bounds of their relia-
bility of such techniques, and the opportunities for their improvement.

(f) Manpower Training. — The Administrator shall establish and promote
programs and workshops to train or facilitate the training of Federal labora-
tory and technical personnel in existing or newly develoi>ed screening and
monitoring techniques.

fg) Exchange of Research and Development Results. — The Administrator
shall, in consultation with the Secretary of Health, Education, and Welfare and
other heads of appropriate agencies, establish and coordinate a system for
exchange among Federal, State, and local authorities of research and develop-
ment results re.specting toxic chemical substances and mixtures, including a sys-
tem to facilitate and promote the development of standard data format and
analysis and consistent testing procedures.

651

IXSPEXTIONS

Sec. 11. (a) Is General. — For purposes of enforcement of this Act the Ad-
ministrator, or any representative of the Administrator, duly designated by
the Administrator, may inspect any establishment, facility, or other premises
in which chemical substances or mixtures are manufactured, processed, stored,
or held before or after their distribution in commerce and any conveyance
being used to transport chemical substances or mixtures in connection with
distribution in commerce. Such an inspection may only be made upon present-
ing appropriate credentials and a written notice to the owner, operator, or
agent in charge of the premises or conveyance to l>e inspected. A separate notice
shall be given for each such inspection but a notice shall not be required for
each entry made during the period covered by the inspection. Each such inspec-
tion shall be commenced and completed with reasonable promptness and shall
be conducted at reasonable times, within reasonable limits, and in a reasonable
manner.

Cb) Scope. — (1) Except as provided in paragraph (2). an inspection under
subsection (a) shall extend to all things within the premises or conveyance
inspected (including records, files, papers, processes, controls, and facilities)
bearing on whether the requirements of this Act applicable to the chemical sub-
stances or mixtures within such premises or convevance have been complied
with.

(2) No inspection under subsection (a) shall extend to —

(A) financial data.

(B) sales data other than shipment data.

fD) per.sonnel data, or

(E) research data (other than research data required by this Act),
unless the nature and extent of such data are described with reasonable
specificity in the written notice required by subsection (a) for such inspection.

EXPORTS

Sec. 12. (a) General. — (1) Except as provided in paragraph (2) and sub-
section (b), this Act (other than section 8) shall not apply to any chemical
substance, mixture, or an article containing a chemical substance or mixture
if—

(A) it can be shown that such substance, mixture, or article is being
manufactured, processed, sold, or held for sale, for export from the United
States, unless such substance, mixture, or article was, in fact manufactured,
processed, or distributed in commerce, for use in the United States, and

(B) such sub.stance, mixture, or article when distributed in commerce,
or any container, bears a stamp or label stating that such substance, mix-
ture, or article is intended for export.

(2) Paragraph (1) shall not apply to any chemical substance, mixture,
or article if the Administrator finds that the substance, mixture, or article
will cause or significantly contribute to an ^unreasonable risk to health
within the United States or to the environment of the United States. The
Administrator may require, under section 4. testing of a chemical substance
or mixture exempted from this Act by paragraph (1) to determine whether
or not such substance or mixture causes or significantly contributes to an
unreasonable risk to health within the United States or to the environment
of the United States,
(b) Notice. — (1) If any person exports or intends to export to a foreign
country a chemical substance or mixture for which the submission of data is
required under section 4 or 5(d), such person shall notify the Administrator of
such exportation or intent to export and the Administrator shall furnish to
the government of such country notice of the availability of the data submitted
to the Administrator under such section for such substance or mixture.

(2) If anv person exports or intends to export to a foreign country a chemical
substance or mixture for which a rule has been proposed or promulgated under
section 5 or 6, or with respect to which an action is pending, or relief has been
granted under section 7. such person shall notify the Administrator of such
exi)ortation or intent to export and the Administrator shall furnish to the
government of such country notice of such rule, action, or relief.

652

ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES

Sec. 13 (a) In General. — (l)The Secretary of the Treasury shall refuse
entry into the customs territory of the United States (as defined in general
headnote 2 to the Tariff Schedules of the United States) of any chemical sub-
stance, mixture, or article containing a chemical substance or mixture offered
for entry if —

( A) it fails to comply with any rule in effect under this Act, or
{ B) it is offered for entry in violation of section .j. a rule or order under
section 5 or 6, or an order issued in an action brought under section 5 or 7.

(2) If a chemical substance, mixture, or article is refused entry under para-
graph (1), the Secretary of the Treasury shall notify the consignee of such
entry refusal, shall not release it to the consignee, and shall cause its disposal
or storage (under such rules as the Secretary of the Treasury may prescribe)
if it has not been exported by the consignee within ninety days from the date of
receipt of notice of such refusal, except that the Secretary of the Treasury
may, pending a review by the Administrator of the entry refusal, release to
the cansignee such substance, mixture, or article on execution of bond for the
amount of the full invoice of such substance, mixture, or article (as such value
is set forth in the customs eatry), together with the duty thereon. On failure
t<^ return such substance, mixture, or article for any cause to the custody of
the Secretary of the Treasury when demanded, such consignee shall be liable to
the United States for liquidated damages equal to the full amount of such bond.
All charges for storage, cartage, and labor on substances, mixtui-es, or articles
which are refused entry or release under this section shall be paid by the
owner or consignee, and in default of such payment shall constitute a lien
against any future entry made by such owner or consignee.

(b) Rules. — The Secretary of the Treasury, after consultation with the
Administrator, shall issue rules for the enforcement of subsection (a) of this
section.

disclosure ok DATA

Sec. 14. (a) In General. — Except as provided by subsection (b), any in-
formation reported to. or otherwise obtained by, the Administrator (or any
representative of the Administrator) under this Act, which is exempt from
disclosure pursuant to subsection (a) of section 552 of title 5, United States
Uode. by reason of subsection (b) (4) of such section, shall not be disclosed by
the Administrator or by any officer or employee of the United States, except that
such information may l)e disclosed —

( 1 ) to officers and employees of the United States —

(A) in conneciion with their official duties under laws for the pro-
tection of health or the environment, or

( R ) for specific law enforcement purposes ;

(2) to contractors with the United States and employees of such con-
tractors if in the opinion of the Administrator such disclosure is necessary
for the satisfactory performance by the contractor of a contract with the
United States entered into on or after the effective date of this Act for the
performance of work in connection with this Act : or

(3) when relevant in any proceeding under this Act. except that dis-
closure in such a proceeding shall be made in such manner as to preserve
confidentiality to the extent practicable without impairing the proceeding.

(b) Data From Health and Safety Studies. — (1) Subsection (a) does not
prohibit the disclosure of —

(A) any health and safety study submitted under this Act with respect
to-
ll) any chemical substance or mixture which on the date the study
is to be disclosed has been offered for commercial di.<tribution. or

(ii) any chemical substance or mixture for which testing is required
under section 4 or for which notification is required under section 5,
and

(R) any data reported to, or otherwise obtained by the Administrator
from a healtli and safety study which relates to a chemical .substance or
mixture described in clause (i) or (ii) of subparagraph (A).
This paragraph does not authorize the release of data which discloses processes
used in the manufacturing or processing of a chemical substance or mixture or,
in the case of a mixture, the release of data disclosing the portion of the mix-
ture comprised by any of the chemical substances in the mixture.

653

(2) If a request is made to the Administrator under subsection (a) of sec-
tion 552 of title 5. United States Code, for information which is described in
the first sentence of paragraph (1) and which is not information described in
the second sentence of such paragraph, the Administrator may not deny such
request on the basis of subsection (b) (3) or (b) (4) of such section.

(c) Desigxatio.x of Confidential Data; Disputes. — (1) In submitting under
this Act, a person may (A) designate the data which the person believes is
entitled to confidential treatment under subsection (a), and (B) submit such
designated data separately from other data submitted under this Act.

(2) If the Administrator proposes to release for in.spection data which has
been designated under paragraph (1)(A). the Administrator shall notify, in
writing and by certified mail, the person who submitted such data of the intent
to release such data. If the release of such data is to be made pursuant to a
request made under section 5.')2(a) of title 5, United States Code, such notice
shall be given immediately upon approval of such request by the Administrator.
The Administrator may not release such data until the expiration of thirty days
after the person submitting such data has received the notice required by this
paragraph.

(d) Criminal Penalty for Wrongful Disclosure. — (1) Any officer or em-
ployee of the United States or former officer or employee of the United States,
who by virtue of such employment or official position has obtained pos.session of,
or has access to, material the disclosure of which is prohibited by subsection (a),
and who knowing that disclosure of .such material is prohibited by such subsec-
tion, willfully discloses the material in any manner to any person not entitled
to receive it. shall be guilty of a misdemeanor and fined not more than $5,000 or
imprisoned for not more than one year, or both. Section 1005 of title 18. United
States Code, does not apply with respect to the publishing, divulging, disclosure,
or making known of, or making available, information reported or otherwise
obtained under this Act.

(2) For the purposes of paragraph (1), any contractor with the United States
who is furnished information as authorized by subsection (a) (2), and any em-
ployee of any such contractor, shall be considered to be an employee of the
United States.

(e) Access by Congress. — Xotwithstandins: any limitation contained in this
section or any other provision of law, all information reported to or otherwise
ol)tained by the Administrator (or any representative of the Administrator)
under this Act shall l>e made available, upon written request of any duly author-
ized committee of the Congress, to such committee.

prohibited acts

Sec. 15. It shall be unlawful for any person to —

(1) fail or refuse to comply with (A) any rule or order promulgated or
issued under section 4. (B) any requirement prescribed by section 5, or (C)
any rule or order promulgated under section 5 or 6 :

"(2) use for commercial purposes a chemical suJistance or mixture which
such person knew or had reason to know was manufactured, processed, or
distributed in commerce in violation of section 5. a rule or order under section
5 or 0. or an order issued in an action brought under section 5 or 7 :

(3) fail or refuse to CA) establish or maintain records. (B) submit re-
ports, notices, or other information, or fC) permit access to or copying of
records, as required by this Act or a rule thereunder: or

(4) fail or refuse to permit entry or inspection as required by section 11.

penalties

Sec 16 (a) Civil — (1) Anv i^rson who violates a provision of section 15 of
this Act shall be liable to the iSiited States for a civil penalty in an amount not to
exceed SJ'^n 000 for eich such violation. Each day such a violation continues shall
for purposes of this subsection constitute a separate violation of section 15

(2) (A) A civil penaltv for a violation of section 15 shall be as.sessed by the
Administrator by an order made on the record after

accordance with this subpara^rraph) for a hearing in accordance ^^'f ^^^^^^f ^J" '^^^
of title 5 United States Code. Before i.ssuing such an order, the Administrator
shall give written notice to the person to be assessed a civil penalty under such

654

order of the Administrator's proposal to issue such order and provide such person
an opportunity to request, within fifteen days of the date the notice is received
by such person, such a liearin^ on the order.

(B) In determining; the amount of a civil penalty, the Administrator shall take
into account the nature, circumstances, extent, and jiravity of the violation or
violations and, with respect to the violator, ability to pay, effect on ability to con-
tinue to do business, any history of prior such violations, the degree of culpability,
and such other matters as justice may require.

(C) The Administrator may, in the Administrator's discretion, compromi.se,
modify, or remit, with or without conditions, any civil penalty which may be
imposed under this subsection. The amount of such penalty, wlien finally deter-
mined, or the amount ajxreed upon in compromise, may be deducted from any
sums owing by the ITnited States to the person charged.

(3) Any person who requested in accordance with paragraph (2) (A) a hearing
respecting the asses.sment of a civil i^enalty and who is aggrieved by an order
assessing a civil penalty may file a petition for judicial review of such order with
the United States Court of Appeals for the District of Columbia Circuit or for
any other circuit in which such person resides or transacts business. Such a
petition may only be filed within the thirty-day period beginning on the date the
order making such assessment was issued.

(4) If any person fails to pay an assessment of a civil penalty after it has
become a final order and does not file a petition for judicial review of the order
in accordance with paragraph (3) or after a court in an action brought under
paragraph (3) has entered final judgment in favor of the Administrator, the
Attorney General shall recover the amount as.sessed (plus interest at currently
prevailing rates from such date) in an action brought in any appropriate dis-
trict court of the United States. In such an action, the validity, amount, and
appropriateness of such penalty shall not be subject to review.

(b) Criminal. — Any person who knowingly or willfully violates any provision
of section 15 shall, in addition to or in lieu of a civil penalty which may be im-
posed under subsection (a) of this section for such violaticm, be subject, upon
conviction, to a fine of not more than $25,000 for each day of violatioji, or to
imprisonment for not more than one year, or both.

(c) Notice, Repurchase, or Replacement. — If in a proceeding for the issuance
of an order luider paragraph (1) to assess a civil penalty against a person the
Administrator determines that such person manufactured, processed, or distrib-
uted in commerce a chemical substance or mixture in violation of a requirement
applicable to such substance or mixture under paragraph (1) or (2) of section
6(a) or otherwise determines by order made on the record after opportunity for
agency hearing that a person has so violated such a requirement, the Administra-
tor may, in such order, require such person (1) to give notice of the risk as.sociated
with the chemical substance or mixture subject to such requirement to processors
or distributors in commerce of such substance or mixture, or to both, and, to the
extent reasonably ascertainable, to any other person in possession of or exposed
to such substance or mixture ; (2) to give public notice of such risk ; (3) to either
replace or repurchase such substance or mixture, as determined by the person
(or persons) to whom the requirement is directed, in the manner prescribed by
the Administrator: pr (4) to take any combination of the actions described in
the preceding clauses.

/ SPECIFIC enforcement AND SEIZURE

Sec. 17. (a) Specific Enforcement. — (1) The district courts of the United
States shall have jurisdiction over civil actions to —

(A) restrain any violation of section 15,

(B) restrain any person from manufacturing or processing a chemical
substance before the expiration of the period before which such manufactur-
ing or processing is prohiliited under section 5,

(D) compel the taking of any action required by or under this Act.
<2) A civil action described in paragraph (1) may be brought —

(A) in the case of a civil action described in subi)aragraph (A) of such
paragraph, in the United States district court for the judicial district wherein
any act, omission, or transaction constituting a violation of section 15 oc-
curred or wherein the defendant is found or transacts business, or

655

(B) in the case of any other civil action described in such paragraph, in
the United States district court for the judicial district wherein the defendant
is found or transacts business.

In any such civil action process may be served on a defendant in any judicial
district in which a defendant resides or may be found. Subpenas requiring at-
tendance of witnesses in any such action may run into any judicial district.

(b) Seizure. — Any chemical substahce or mixture which was manufactured,
processed, or distributed in commerce in violation of this Act or any rule or order
promulgated under this Act or any article containing such a substaiice or mixture
shall be liable to be proceeded against, by process, of libel for the seizure and
condemnation of such substance, mixture, or article, in any district court of the
United States within the jurisdiction of which such substance, mixture, or article
is found. Such proceedings shall conform as nearly as possible to proceedings in
rem in admiralty.

PREEMPTIOX

Sec. 18. (a) Effect ox State Law. — (1) Except as provided in paragraph (2),
nothing in this Act shall affect the authority of any State or political subdivision
of a State to establish or continue in effect regulation of any chemical substance,
mixture, or article containing a chemical or mixture.

(2) Except as provided in subsection (b) —

(A) if the Administrator requires by a rule promulgated under section 4
the testing of a chemical substance or mixture, no State or political subdivi-
sion may, after the effective date of such rule, establish or continue in effect
a requirement for the testing of such substance or mixture for purposes simi-
lar to those for which testing is required under such rule; and

(B) if the Administrator prescril^es a rule or order under section 5 or 6
of this Act (other than a rule imposing a requirement described in subsec-
tion (a) (5 of section 6) which is applicable to a chemical substance or mix-
ture, and which is designed to protect against a risk to health or the
environment associated with such substance or mixture, no State or political
subdivision of a State may, after the effective date of such requirement,
establish or continue in effect a requirement applicable to such substance or
mixture, or an article containing such substance or mixture, and designed
to protect against such risk unless such requirement is identical to the
requirement prescribed by the Administrator or unless such requirement is
adopted under the authority of the Clean Air Act or any other Federal law.

(b) ExE^rPTioN. — Upon application of a State or political subdivision of a State
the Administrator may by rule exempt from subsection (a)(2), under such
conditions as may be prescribed in such rule, a requirement of such State or
political subdivision designed to protect against a risk to health or the environ-
ment associated with a chemical substance, mixture, or article containing a
chemical substance or mixture if —

(2) the State or political subdivision requirement (A) provides a signi-
ficantly higher degree of protection from such risk than the requirement
under "this Act described in subsection (a) (2) and (B) does not, through dif-
ficulties in marketing, distribution, or other factors, unduly burden interstate
commerce.

JUDICIAL REVIEW

Sec. 19. (a) In General.— Not later than sixty days following the promulgation
of a rule under section 4, 5. or 0(a) of this Act. any person may file a petition for
judicial review of such rule with the United States Court of Appeals for the Dis-
trict of Columbia Circuit or for the circuit in which such person resides or in
which such person's principal place of business is located. Copies of the petition
shall be forthwith transmitted by the clerk of such court to the Administrator
and to the Attornev General. The Administrator shall transmit to the Attorney
General, who shall" file in the court, the record of the proceedings on which the
Administrator leased such rule as provided in section 2112 of title 28, United

656

states Code. For purposes of this section, the term "record" means such rule ; any
transcript required of any oral presentation ; any written submission of interested
parties; and any other information which the Administrator considers to be
relevant to such rule and with respect to which the Administrator, on or before
the Administrator, the court may rule, published a notice in the Federal Register
identifying such information.

(b) Additional Data. — If the petitioner applies to the court for leave to adduce
additional data, views, or arguments, and shows to the satisfaction of the court
that such additional data, views, or arguments are material and that there are
reasonable grounds for the petitioner's failure to adduce such data, views, or
arguments in the proceeding before the Administrative, the court may order the
Administrator to provide additional opportunity for oral presentation of data,
views, or arguments and for written submissions. The Administrator may modify
findings or determinations upon which the rule subject to review by such court
was based, or make new findings or determinations by reason of the additional
data, views or arguments so taken and shall file such modified or new findings
or determinations, and the Administrator's recommendation, if any, for the modi-
fication or selling aside of such rule, with the return of such additional data,
views, or arguments.

(c) Authority and Review Standard. — (1) Upon the filing of a petition under
subsection (a), the court shall have jurisdiction (A) to review the rule involved
in accordance with chapter 7 of title 5, T'nited States Code, and (B) to grant ap-
propriate relief, including interim relief, as provided in such chapter. Any rule
promulgated by the Administrator under section 4, 5, or 6 of this Act and reviewed
under this section shall be affirmed, unless the determination or findings required
to be made by the Administrator under the applicable section are not supported
by substantial evidence on the record taken as a whole.

(2) The judgment of the court affirming or setting aside, in whole or in part,
any rule reviewed in accordance with this section shall be final to review by the
Supreme Court of the United States upon certiorari or certification, as provided
in section 1254 of title 28, United States Code.

(3) The judgment of the court in an action brought pursuant to subsection
(a) may include an award of costs of suit and reasonable fees for attorneys and
expert witnesses if the court determines that such an award is appropriate. The
Supreme Court of tlie United States in its decision on a review of a judgment
in such an action may provide for the award of costs of suit and reasonable fees
for attorneys if the court determines that such an award is appropriate.

(d) Other Remedies. — The remedies provided in this .section shall be in
addition to and not in lieu of any other remedies provided by law.

citizen's civil actions

Sec. 20. (a) In General. — Except as provided in subsection (b), any person
may commence a civil action —

(1) against any per.son (including (A) the United States, and (B) any
other governmental in.'^trumentality or agency to the extent iiermitted by the
eleventh amendment to the Constitution) who is alleged to be in violation
of this Act or any rule prescribed under section 4, 5, or 6(a) to restrain such
violation, or

(2) against the Administrator to compel the Administrator to perform
any act or duty under this Act which is not discretionary.

Any civil action under paragraph (1) shall be brought in the United States dis-
trict court for the district in which the alleged violation occurred or in which
the defendant resides or in which the defendant's principal place of business is
located. Any action brought under paragraph (2) shall be brought in the United
States District Court for the District of Columbia, or the United States district
court for the judicial district in which the plaintiff is domiciled. The district
courts shall have jurisdiction over suits brought under this section, without
regard to tlie amount in controver.sy or the citizenship of the parties. In any
civil action under this subsection process may be served on a defendant in any
judicial district in which the defendant resides or may he found and subpenas
for witnes.ses may run into any judicial district.

657

(b) Limitation. — No civil action may be commenced —

(1) under subsection (a)(1) to restrain a violation of this Act or rule
under this Act —

(A) before the expiration of sixty days after the plaintiff has given
notice of such violation (i) to the Administrator, and (ii) to the person
who is alleged to have committed such violation, or

(2) under subsection (a) (2) before the expiration of sixty days after the
plaintiff has given notice to the Administrator of the alleged failure of the
Administrator to perform an act or duty which is the basis for such action
or, in the case of an action under such subsection for the failure of the Ad-
ministrator to file an action under section 7, before the expiration of ten
days after such notification.

Notice under this subsection shall be given in such manner as the Administrator
shall prescribe by rule.

(c) General. — (1) In any action under this section, the Administrator, if not
a party, may intervene as a matter of right.

(2) The court, in i.ssuing any final order in any action brought pursuant to
subsection (a), may award costs of suit and reasonable fees for attorneys and
expert witnes.ses if the court determines that such an award is appropriate. Any
court, in issuing its decision in an action brought to review such an order, may
award costs of suit and reasonable fees for attorneys if the court determines
that such an award its appropriate.

(3) Nothing in this section shall restrict any right which any person (or class
of persons) may have under any statute or common law to seek enforcement
of this Act or any rule under this Act or to seek any other relief.

(d) Consolidation. — When two or more civil actions brought under subsec-
tion (a) involving the same defendant and the same issues or violations are
pending in two or more judicial districts, .such pending actions, upon application
of such defendants to such actions which is made to a court in which any such
action is brought, may, if such court in its discretion so decides, be consolidated
for trial by order (issued after giving all parties reasonable notice and oppor-
tunity to be heard) of such court and tried in —

(1) any district which is selected by such defendant and in which one of
such actions is pending,

(2) a district which is agreed upon by stipulation between all the parties
to such actions and in which one of such actions is pending, or

(3) a district which is selected by the court and in which one of such
actions is pending.

The court issuing slich an order shall give prompt notification of the order to
the other courts in which the civil actions consolidated under the order are
pending.

citizen's petitions

Sec. 21. (a) In General. — Any person may petition the Administrator to ini-
tiate a proceeding for the issuance, amendment, or repeal of a rule under section
4, 5(c), or 6(a).

(b) Procedures.— (1) Such petition shall be filed in the principal office of the
Administrator and shall set forth the facts which it is claimed established that
it is necessary to issue, amend, or repeal a rule under section 4, 5(c). or 6(a).

(2) The Administrator may hold a public hearing or may conduct such investi-
gation or proceeding as the Administrator deems appropriate in order to deter-
mine whether or not such petition should be granted.

(3) Within ninetv days after filing of a petition described in paragraph (1),
the Administrator shall either grant or deny the petition. If the Administrator
grants such petition, the Administrator shall promptly commerce an appropriate
proceeding in accordance with section 4, 5(c), or 6(a). If the Administrator
denies such petition, the Administrator shall publish in the Federal Register the
Administrator's reasons for such denial.

658

(4) (A) If the Administrator denies a petition filed under this section (or if
the Administrator fails to grant or deny such petition within the ninety-day
period) the petitioner may commence a civil action in a United States district
court to compel the Administrator to initiate a rulemaking proceeding to take
the action requested. Any such action shall be filed within sixty days after the
Administrator's denial of the petition or if the Administrator fails to grant or
deny the i>etition within ninety days after filing the petition, within sixty days
after the expiration of the ninety-day period.

(B) If in an action under subparagraph (A) respecting a petition to initiate
a proceeding to issue a rule under section 4, 5(c) . or 6(a) the petitioner demon-
strates to the satisfaction of the court, by a preponderance of the evidence in a
de novo proceeding before the court, that —

(i) in the case of a petition to initiate a proceeding for the issuance of a
rule under section 4, shall the manufacture, distribution in commerce, pro-
cessing, use, or disposal of the chemical substance or mixture to be .subject
to such rule may cause or significantly contribute to an unreasonable risk
to health or the environment,

(ii) in the case of a petition to initiate a proceeding for the issuance of a
rule under section 5(c), that the manufacture, processing, distribution in
commerce, use, or di.<<posal of a chemical substance petitioned to be included
in a list compiled under such rule causes or significantly contributes to an
unreasonable risk to health or the environment, or

(iii) in the case of a i>etition for the issuance of a rule under section 6
(a), that there is a reasonable basis to conclude that the manufacture,
processing, distribution in commerce, use. or disposal of a chemical sub-
stance or mixture to be subject to such rule causes or significantly con-
tributes to or will cause or significantly contribute to an unreasonable risk
to health or the environment,

the court shall order the Administrator to initiate the action requested by the
petitioner unless the court finds, after con.sidering the extent of the risk to
health or the environment alleged by the petitioner in relation to the extent of
risks to health or the environment with respect to which the Administrator is
taking action under this Act. the resources available to the Administrator to take
action requested by the petitioner, and other relevant factors, the failure of the
Administrator to initiate such action was not unreasonable.

(C) The court in issiuing any final order in any action brought pur.«;uant to
subparagraph (A) may award costs of suit and reasonable fees for attorneys
and expert witnesses if the court determines that .«;uch an award is appropriate.
Any court, in issuing its decision in an action brought to review such an order,
may award costs of suit and reasonable fees for attorneys if the court deter-
mines that such an award is appropriate.

(5) The remedies under this .section shall be in addition to. and not in lieu of
other remedies provided by law.

NATIONAL DEFENSE WAIVER

Sec 22. The Administrator shall waive compliance with any provision of this
Act upon a request and determination by the President that the requeste<l waiver
is neces.sary in the interest of national defensie. The Administrator shall main-
tain a written record of the basis upon which such waiver was granted and make
such record available for in camera examination when relevant in a judicial
proceeding under this Act. Upon the issuance of such a waiver, the Administra-
tor .<ihall publi.sh in the Federal Register a notice that the waiver was granted
for national defense purposes, unless, upon the request of the President, the
Administrator determines to omit such publication because the publication itself
would be contrary to the interests of national defense, in which event the Admin-
istrator shall submit notice thereof to the Armed Services Committees of the
Senate and the House of Representatives.

EMPLOYEE protection

Sec. 23. (a) In General. — Xo employer may discharge any employee or other-
wise discriminate against any employee with respect to the employee's compen-
sation, terms, conditions, or privileges of employment becau.se the employee (or
any person acting pursuant to a request of the employee) ha.s —

(1) commenced, cau.se to be commenced, or is about to commence or cause
to be commenced a proceeding under this Act ;

659

(2) testified or is about to testify in any such proceeding: or

(3) assQSted or participated or is about to assist or participate in any
manner in sucli a proceeding or in any other action to carry out the pur-
poses of this Act.

(b) Remedy. — (1) Any employee who believes that the employee has been dis-
charged or otherwise discriminated against by any person in violation of sub-
section (a) of this section may, within thirty days after such alleged violation
occurs, file (or have any person file on the employee's behalf) a complaint with
the Secretary of Labor (hereinafter in this section referred to as the "Secre-
tary") alleging such discharge or discrimination. Upon receipt of such a com-
plaint, the Secretary shall notify the person named in the complaint of the filing
of the complaint.

(2) (A) Upon receipt of a complaint filed under paragraph (1), the Secretary
shall conduct an investigation of the violation alleged in the complaint. "Within
thirty days of the receipt of such complaint, the Secretary shall complete such
investigation and shall notify in writing the complainant (and any person acting
on behalf of the complainant) and the person alleged to have committed such
violation of the results of the investigation conducted pursuant to this para-
graph. Within ninety days of the receipt of such complaint the Secretary shall,
unless the proceeding on the complaint is terminated by the Secretary on the
basis of a settlement entered into by the Secretary and the person alleged to have
committed such violation, issue an order either providing the relief prescribed
by subparagraph (B) or denying the complaint. An order of the Secretary shall
be made on the record after notice and opportunity for agency hearing. The
Secretary may not enter into a settlement terminating a proceeding on a com-
plaint without the participation and consent of the complainant.

(B) If in response to a complaint filed under paragraph (1) the Secretary
determines that a violation of subsection (a) of this section has occurred, the
Secretary sliall order (i ) the person who committed such violation to take atfirm-
ative action to abate the violation, (ii) such person to reinstate the com-
plainant to the complainant's former position together with the compensation
(including back pay), terms, conditions, and privileges of the complainant's
employment, (iii) compensatory damages, and (iv) where appropriate, ex-
emplary damages. If such an order is issued, the Secretary, at the request of the
complainant, shall assess against the person against whom the order is issued a
sum equal to the aggregate amount of all costs and expenses (including attor-
ney's fees) reasonably incurred, as determined by the Secretary, by the com-
plainant for, or in connection with, the bringing of the complaint upon which the
order was issued.

(c) Re\'iew. — (1) Any i^erson adversely affected or aggrieved by an order is-
sued under subsection (b) may obtain review of the order in the United States
Court of Appeals for the circuit in which the violation, with respect to which
the order was issued, allegedly occurred. The petition for review must be filed
within sixty days from the issuance of the Secretary's order. Review shall con-
form to chapter 7 of title 5 of the United States Code.

(2) An order of the Secretary, with respect to which review could have been
obtained under paragraph (1), shall not be subject to judicial review in any
criminal or other civil proceeding.

(d) Enforcement. — (1) Whenever a person has failed to comply with an order
issued under subsection (b)(2), the Secretary shall file a civil action in the
United States district court for the district in which the violation was found to
occur to enforce such order. In actions brought under this subsection, the district
courts shall have jurisdiction to grant all appropriate relief, including injunctive
relief and compensatory and exemplary damages. Civil actions brought under
this subsection shall be heard and decided expeditiously.

(2) Anv nondiscretionarv dutv imposed by this section is enforceable in man-
damus proceeding brought under section 1361 of title 28. United States Code.

(e) Exclusion.— Subsection (a) of this section shall not apply with respect to
anv emplovee who, acting without direction from the employee's employer (or
any agent "of the employer), deliberately causes a violation of any requirement of
this Act.

EMPLOYMENT EFFECTS

Sec. 24. (a) In General.— The Administrator shall evaluate on a continuing
basis the potential effects on employment (including reductions in employment
or loss of employ^ment from threatened plant closures of —

(1) the issuance of a rule or order under section 4, 5, or 6, or

660

(2) a requirement of section 5.
{b)(l) Investigations. — Any employee (or any representative of an em-
ployee) may request the Administrator to make an investigation of —

(A) a discharge or layoff or threatened discharge or layoff of the em-
ployee, or

(B) adverse or threatened adverse effects on the employee's employment,
allegedly resulting from a rule or order under section 4, 5, or 6 or a requirement
of section 5. Any such request shall be made in writing, shall set forth with
reasonable particularity the grounds for the request, and shall be signed by the
employee, or representative of such employee, making the request.

(2) (A) Ui>on receipt of a request made in accordance with paragraph (1) the
Administrator shall (i) conduct the investigation requested, and (ii) if requested
by any interested person, hold public hearings on any matter involved in the
investigation unless the Administrator determines that there are no reasonable
grounds for holding such hearings. If the Administrator makes such a determi-
nation respecting a request for a hearing, the Administrator shall notify in writ-
ing the person requesting the hearing of the determination and the reasons
therefor.

(B) If public hearings are to be held on any matter involved in an investiga-
tion conducted under this subsection —

(i) at least five days' notice shall be provided the person making the
request for the investigation and any person identified in such request,

(ii) a transcript shall be made of the hearings, and

(iii) each employee who made or for whom was made a request for such
hearings and the employer of such employee shall be required to present
information resi>ecting the applicable matter referred to in paragraph (1)
(A) or (1) (B) together with the basis for such information.

(3) Upon completion of an investigation under paragraph (2), the Adminis-
trator shall make findings of fact, shall make such recommendations as the
Administrator deems appropriate, and sliall make available to the public such
findings and recommendations.

(4) In connection with any investigation or public hearing conducted under
this subsection, the Administrator may issue subpenas for the attend^^nce and
testimony of witnesses and the production of relevant papers, books, and docu-
ments, and the Admini.strator may administer oaths. Witnesses summoned shall
be paid the same fees and mileage that are paid witnesses in the courts of the
United States. In case of contumacy or refusal to obey a subpena served upon
any person under this paragraph, the United States district court for any district
in wliicli such person is found or resides or transacts business, upon application
by the United States and after notice to such person, shall have jurisdiction to
issue an order requiring such person to api>ear and give testimon.v before the
Administrator to appear and produce papers, books, and documents before the
Administrator, or both, and any failure to obey such order of the court may be
punished by such court as a contempt thereof.

STUDIES

Sec. 25. (a) Indemnification Study. — The Administrator shall conduct a
study of all Federal laws administered by the Administrator for the purpose of
determining whether and under what conditions, if any, indemnification should
be accorded an.v person as a result of any action taken by the Administrator
under any such law. The study shall —

(1) include an estimate of the probable cost of any indemnification pro-
grams which may be recommended :

(2) include an examination of all viable means of financing the cost of any
recommended indemnification : and

(3) be completed and submitted to Congress not less than two years from
the effective date of this Act.

The General Accounting Office shall review the adequacy of the study submitted
to Congress pursuant to paragraph (3) and shall report the results of its review
to the Congress within six months of the date such study is submitted to
Congress.

(b) Classification. Storage, and Retrieval Stttdy. — The Council on En-
vironmental Qualit.v, in consultation with the Administrator, the Secretary of
Healtli, Education, and Welfare, the Secretary of Commerce, and the heads of
other appropriate Federal departments or agencies, shall coordinate a study of

661

the feasibility of establishing (1) a standard classitieation system for chemical
substances and related substances, and (2) a standard means for storing;- and
obtaining? rapid access to information respectinj^ such substances, A reiK)rt on
such study shall be completed and submitted to ('(Ui^jress not later than eighteen
months after the effective date of this Act.

ADMINISTRATION OF ACT

Sec. 26. (a) Cooperation of Fkderal Agilvcies. — I'pon request by the Admin-
istrator, each Federal department and agency is authorized —

(1) to make its services, i)ersonnel, and facilities available (with or with-
out reimbursement) to the Administrator to assist the Administrator in the
administration of this Act ; and

(2) to furnish to the Administrator such information, data, estimates, and
statistics, and to allow the Administrator access to all information in its
possession as the Administrator may reasonably determine to be necessary
for the administration of this Act.

(b) Fees. — (1) The Administrator nuny. by rule, require the payment of a
reasonable fee ivtmi any person required to submit data under secti(m 4 or .") of
this Act to defray the cost of administering this Act. Such rules shall not pro-
vide for any fee in excess of $2,500 or in tlie case of a small business concern,
any fee in excess of $100, In setting such a fee, the Administrator shall take into
account the ability to pay of the person required to submit such data and the
cost to the Administrator of reviewing such data. Such rules may provide for
sharing such a fee in any case in which the exi>enses of testing are .shared under
section 4 or 5 of this Act.

(2) The Administrator, after consultation with the Administrator of the
Small Business Administration, shall by rule prescribe standards for determin-
ing the i)ersons which (pialify as small business concerns for purposes of this
sub.section.

(c) Action "With Respect to Categories. — (1) Any action authorized or
required to be taken by the Administrator under any provision of this Act with
respect to a chemical substance or mixture may be taken by the Administrator
in accordance with that provision with respect to a category of chemical sub-
stances or mixtures. AVhenever the Administrator takes action under a pro-
vision of this Act with respect to a category of chemical substances or mixtures,
any reference in this Act to a chemical substance or mixture (insofar as it relates
to such action) shall be deemed to be a reference to each chemical substance or
mixture in such category.

(2) For purposes of p,'u-i graph (1) :

(A) The term "category of chemical substances" means a group of chemical
substances the members of which are similar in molecular structure, in physical,
chemical, or biological properties, in use. or in mode of entrance into the liuman
body or into the environment, or the members of which are in some other way
suital)le for classification as such for i)urposes of this Act. excei)t that such term
does not mean a groui> of chemical substances which are grouped together solely
on the basis of their being new chemical substances.

(R) The term ""category of mixtures" means a group of mixtures the members
of which are similar in molecular structure, in physical, chemical, or biological
properties, in use, or in mode of entrance into the human body or into the envi-
ronment, or the members of which are in some way suitable for classification as
such for i)urposes of this Act.

(d) Assistance Office.— The Administrator sliall establish in the Environ-
mental Protection Agency an identifiable office to provide technical and other non-
financial assistance to manufacturers and processors of chemical substances and
mixtures respecting the requirements of this Act api)licable to such manufac-
turers and processors, the policy •fif the Agency respecting the application of such
requirements to such manufacturers and processors, and the means and methods
by which such manufacturers and processors may comply with such
requirements.

development and evaluation of test methods

Sec 27. (a) The Secretary of Health, Education, and Welfare, in consultation
with the Administrator and acting through the Assistant Secretary for Health,
may conduct, and make grants to public and nonprofit private entities and enter

662

into contracts with public and private entities for, projects for the development
and evaluation if inexpensive and efficient methods (1) for determining and
evaluating the health and environmental effects of chemical substances and
mixtures, and their toxicity, i)ersistence, and other characteristics which affect
health and the environment, and (2) which may be used for the development of
test data to meet the requirements of rules promulgated under section 4. The
Administrator shall consider such methods in prescribing under section 4 stand-
ards for the development of test data.

(b) No grant may be made or contract entered into under subsection (a) unless
an application therefor has been submitted to and approved by the Secretary.
Such an application shall be submitted in such form and manner and contain
such information as the Secretary may require. The Secretary may apply such
conditions to grants and contracts under subsection (a) as the Secretary deter-
mines are necessary to carry out the purposes of such subsection. Contracts may
be entered into under such subsection without regard to sections 3048 and 3709
of the Revised Statutes (31 U.S.C. 529 ; 41 U.S.C. 5).

(2) The Secretary shall i>eriodically publish in the Federal Register reports
describing the progress and results of any contract entered into or grant made
under this section.

STATE PROGRAMS

Sec. 28. (a) For the purpose of complementing (but not reducing) the author-
ity of, or actions taken by, the Administrator under this Act, the Administrator
may make grants to States for the establishment and operation of programs to
prevent or eliminate unreasonable risks within the States to health or the envi-
ronment which are associated with a chemical substance or mixture and with
respect to which the Administrator is unable to take action under this Act for
their i)revention or elimination. The amount of a grant under this subsection
shall be determined by the Administrator, except that no grant for OJiy State
program may exceed 7.") i)er centum of the establishment and operation costs (as
determined by the Administrator) of such program during the period for which
the grant is made.

(b) (1) No grant may be made under subsection (a) unless an application
therefor is submitted to and approved by the Administrator. Such an application
shall be submitted in such form and manner as the Administrator may require
and shall —

(A) set forth the need of the applicant for a grant under subsection (a),

(B) identify the agency or agencies of the State which shall establish or
operate, or both, the program for which the application is submitted,

(E) provide for the making of such reports and evaluations as the Admin-
istrator may require, and

(F) contain such other information as the Administrator may prescribe.
(2) The Administrator may approve an application submitted in accordance

with paragraph (1) only if the ai)plicant has estalilished to the satisfaction of
the Administrator a priority need, as determined under rules of the Administra-
tor, for the grant for which the application has been submitted. Such rules shall
take into consideration the seriousness of the health effects in a State which are
associated with cliemical substances or mixtures, including cancer, birth defects,
and gene mutations, the extent of the exposure in a State of human beings and
the enviromnent to cliemical substances and mixtures, and the extent to which
chemical substances and mixtures are manufactured, processed, used, and dis-
posed of in a State.

(c) Not later than six months after the end of each of the fiscal years 1979,
1980, and 1981. the Administrator sliall submit to the Congress a report respect-
ing the i)rograms assisted by grants under subsection (a) in tlie preceding fiscal
year and the extent to wliich the Administrator has disseminated information
respecting such programs.

663

(d) For tho purpose of inakiiij; j^runts under subsection (u) there are au-
tliorized to he appropriated .1;1,(K>0,0()0 for the liscal year ending? September 30
1978, .l;i,()0O.OO() for the liscal year ending' Septeml)er 30, 107J) and SI 000 (k)(>
for the liscal year ending' September 30, 11)80. Sums appropriated under this
subsection shall remain avaihible until expended.

SUNSHINE IN (iOV-EKN.MENT

Si;c. (a) Each officer or employee of the Admini.s^rator and the Secretary
of Health, Education and Welfare who —

(1) performs any function or duty under this Act ; and

(2) has any known linancial interest (A) in any person subject to this
Act, or (B) III any person who applies for or receives any grant, contract,
or other form of linancial assistance pursuant to this Act ;

shall, beginninj; on February 1, 1«)77, annually lile with the Administrator or
the Secretary of Health, Education and Welfare, as appropriate, a written
statement concerninj;- all such interests held by such officer or employee during?
the precedin;;- calendar year. Such statement shall be available to the public,
(bj 'J'he Administrator and said Secretary shall —

(1) act within ninety days after the date of enactment of this Act—
(A) to detine the term "known financial interest" for purposes of

subsection ( a ) of this section ; and

(H> to establish the methods by which the reciuirement to file written
statements specified in subsection (a) of this section will be monitored
and enforced, includin;; approiu-iate provisions for the filinjf by such
officers and employees of such statements and the review by the Admin-
istrator and said Secretary of such statements ; and

(2) report to the Congress on June 1 of each calendar year with respect
to such disclosures and the actions taken in regard thereto during the
preceding calendar year.

(c) In the rules prescribed in subsection (b) of this section, the Administrator
and said Secretary may identify specific positions within the appropriate agency
which are of a nonregulatory or nonpolicymakiug nature and provide that
officers or emi)l()yees occupying such positions shall be exempt from the re(iuire-
ments of this .section.

(d) Any officer or employee who is subject to. and knowingly violates, this
section or any regulation issued thereunder, shall be fined not more than $2,500
or imprisoned not more than one year, or both.

AUTIIOKIZATION FOK AI'PKOl'KIATIONS

Sec. 30. There are authorized to be appropriated to the Administrator for
purposes of carrying out this Act (other than sections 27 and 28 and subsections
(a) and (c) through (g) of section 10 thereof) Jf;i2.G2r).0(X) for the fiscal year
ending Septenjber 30, 1078. $10,200,000 for the fiscal year ending September 30.
1071), and $17,3r)0.(K)() for the fiscal year ending Septeml)er 30. 1080. No part of
the funds appropriated under this section may l)e u.sed to construct any research
laboratories.

ANNUAL REPORT

Sec. 31. The Administrator shall prepare and submit to the I'resident and
the ('(mgre.ss on or l)ef(u-e January 1. 11)79. and on or before January 1 of each
succeeding year a comprehensive report on the administrati(m of this Act during
the preceding fiscal vear. Such report shall include —

(1) a list of the testing reciuired under section 4 during the year for which
the report is made and an estimate of the costs incurred during such year
bv the persons re(iuired to perfonn such tests : • - ^v,

' (2) the number of notices received during such .vear under section t.ne.
number of such notices received during such year under such section for
chemical substances subject to a section 4 rule, and a summary of any
action taken during such year under section 5(g) :

(3) a list of rules issued during such year under section (> :

(4) a list, with a brief statement of the issues, of completed or pending
judicial actions under this Act during such year ; , . . .

(5) a summary of major problems encountered in the administration ot

^^^et^suclTrecommendations for additional legislation as the Administrator
deems necessary to carry out the purposes of this Act.

664

RULE KEVIKW

Sec. 32. (a) Any rule prescribed pursuant to this Act by the Administrator
may by resolution of either House of Congress be disapproved, in whole or in
part, if such resolution of disapi)roval is adopted not later than the end of the
lirst period of (JO calendar days when Conj^ress is in session (whether or not
continuous) which period begins on the date such rule is tinally adopted by the
Administrator, Secretary of the Treasury, or Secretary of Health, Education,
and Welfare, as the case may be. The authority which prescribes a rule pursuant
to this Act shall transmit such rule to each House of Congress immediately upon
its tinal adoption. Upon adoption of such a resolution of disapproval by either
House of Congress within such (JO-day period, such rule, or part thereof, as the
case may be, shall cease to be in effect.

(b) Congressional inaction on or rejection of a resolution of disapproval of
a rule promulgated under this Act shall not be deemed an expression of approval
of such rule.

EFFECTIVE DATE

Sec. 38. This Act shall take effect October 1. 1977.
The motion was {i<>:mMl to.

The Semite bill was ordered to he read a third time, was read the
thii-d time, and passed, and a motion to reconsider was laid on the
table.

A similar House bill (H.R. 14():i2) was laid on the table.

CHAPTER IV

COXFEREXCE REPORT AXT) DEBATES

79-313 0 - 77 - 43

94th Congress ) HOUSE OP IlEPRESENTATIVES ( Report
2d Session ) ( No. 94-1679

TOXIC SUBSTANCES CONTROL ACT

Septembeb 23, 1976. — Ordered to be printed

Mr. Staggers, from the committee of conference,
submitted the following

CONFERENCE REPORT

[To accompany S. 3149]

The committee of conference on the disagreeing votes of the two
Houses on the amendment of the House to the bill (S. 3149) to
regulate commerce and protect human health and the environment by
requiring testing and necessary use restrictions on certain chemical
substances, and for other purposes, having met, after full and free
conference, have agreed to recommend and do recommend to their
respective Houses as follows :

That the Senate recede from its disagreement to the amendment
of the House and agree to the same with an amendment as follows :

In lieu of the matter proposed to be inserted by the House amend-
ment insert the following :

*******

(667)

668

JOINT EXPLANATORY STATEMENT OF THE
COMMITTEE OF CONFERENCE

The managers on the part of the House and the Senate at the con-
ference on the disagreeing votes of the two Houses on the amendment
of the House to the bill (S, 3149) to regulate commerce and protect
human health and the environment by requiring testing and necessary
use restrictions on certain chemical substances, and for other purposes,
submit the following joint statement to the House and the Senate in
explanation of the effect of the action agreed upon by the managers
and recommended in the accompanying conference report:

The House amendment struck out all of the Senate bill after the en-
acting clause and inserted a substitute text.

The Senate recedes from its disagreement to the amendment of the
House with an amendment which is a substitute for the Senate bill
and the House amendment. The differences between the Senate bill,
the House amendment, and the substitute agreed to in conference are
noted below, except for clerical corrections, conforming changes made
necessary by agreements reached by the conferees, and minor draft-
ing and clarifying changes.

FINDINGS, POLICY, AND INTENT

Senate hill {section 2)

Section 2(a) outlines Congressional policy underlying th§ Toxic
Substances Control Act. Congress finds that : human beings and the
environment are exposed to numerous chemical substances and mix-
tures ; some of these may cause or contribute to an unreasonable risk of
injury to health or the environment; and the effective regulation of
such substances and mixtures in interstate commerce necessitates regu-
lation of intrastate commerce as well.

Subsection (b) sets forth that it is the policy of the United States
that adequate data on the health and environmental effects of such
chemical substances and mixtures should be developed. Such data de-
velopment should be the responsibility of those who manufacture and
process such chemical substances and mixtures. Adequate authority
should exist to regulate chemical substances and mixtures, but the
exercise of such authority should not unduly impede technological
innovation.

Subsection (c) contains a declaration of Congressional intent as to
how the Administrator shall fulfill the responsibilities under this Act.
The Administrator shall carry out this Act in a reasonable and pru-
dent manner and consider the environmental, economic, and social im-
pact of any action taken or proposed under this Act.
Home amendment {section 2)

The House amendment is nearly identical to the Senate bill.
However, the House amendment confines its data development man-

(55)

669

date to hazardous or potentially hazardous substances and mixtures,
in contrast to the broader mandate contained in the Senate bill.
Conference substitute {section 2)

The conference substitute follows the Senate provision. Adequate
data should be developed concerning the health and environmental
effects of chemical substances and mixtures. Such data development
should be the responsibility of those who manufacture or process such
substances and mixtures. Adequate authority should exist to regulate
chemical substances and mixtures which present an unreasonable risk
of injury to health or the environment and to take action with respect
to chemical substances and mixtures which are imminent hazards.

DEFINITIONS

Senate hill {sections)

The Senate bill includes definitions for the Act, the principal ones
of which are as follows :

1. Chemical substance is defined as (i) any organic or inorganic
substance of a particular molecular identity including a combination
of such substances occurring as a result of a chemical reaction, or (ii)
any element or uncombined radical. The term specifically excludes any
mixture ; any pesticide ; tobacco and tobacco products ; special nuclear
materials or by-product materials as defined in the Atomic Energy
Act of 1954; articles which if sold would be subject to the tax imposed
by section 4181 of the Internal Revenue Code of 1954 (i.e., pistols,
firearms, revolvers, shells and cartridges) ; any substance found in or
on any food, drug, cosmetic or device and any substance produced
for research and development purposes intended only for use in or
on any food, drug cosmetic or device.

2. The tenn "environment" includes human beings and their en-
vironment, water, atmosphere, and land and the interrelationships
which exist among and between these.

3. "Manufacture" means to import, produce, or manufacture for
commercial purposes.

4. The terih "mixture" means any combination of two or more
chemical substances if such substances do not react chemically with
each other and if the combination is not a result of the chemical
reaction. Mixture also includes combinations of substances which occur
in nature.

The Senate bill authorizes the Administrator to exclude from cover-
age of the Act any chemical substance or mixture if the Administrator
determines, by rule, that the substance or mixture does not present an
unreasonable risk of injury to health or the environment. However,
the exclusion shall not apply to section 7 or section 8(e) of the Senate
bill.

House aviendmerit {section 3)

1. The House definition of "chemical substance" is similar to that
of the Senate bill, except that the term includes organic or inorganic
substances or %'ombinations of such substances occurring in nature. The
exclusions from the definition of chemical substances are similar to the
Senate bill, although the House amendment specifically excludes food
additives along with foods, drugs, cosmetics, and devices.

670

2. The House amendment defines "environment" to include water,
air and land, and the interrelationships which exist among and be-
tween water, air and land, and all living things.

3. The House amendment, like the Senate bill, defines manufac-
ture to mean import, produce, or manufacture, but the definition is
not limited to such activities done for commercial purposes.

4. The term "mixture' is defined to mean any combination of two or
more chemical substances if the combination does not occur in nature
and is not, in whole or in part, the result of a chemical reaction. How-
ever, certain reaction-produced combinations are included in the
term "mixture" in order to prevent disparate treatment of identical
combinations simply because of the number of steps used in the manu-
facture of the combination. If each of the chemical substances compris-
ing the combination is not a new chemical substance and if the com-
bination could have been manufactured for commercial purposes with-
out a chemical reaction occurring at the time the substances comprising
the combination were combined, then the combination is included
within the term "mixture".

The House bill does not contain general authority for the Ad-
ministrator to exclude any chemical substance or mixture from the pro-
visions of the bill. However, section 5(i) (5) of the House amendment
authorizes the Administrator to exclude any chemcial substance from
the notification requirements of section 5 if the Administrator deter-
mines, by rule, that the substance will not cause or significantly con-
tribute to an unreasonable risk to health or the environment.

Conference substitute {section 3)

The conference substitute adopts the definitions contained in the
House amendment.

The conferees recognize that virtually no chemical substance exists
in a completely pure state and intend that any reference to a chemical
substance includes all impurities and concomitant products, including
incidental reaction products, contaminants, co-products, and trace
materials. Thus the definition of term "chemical substance" shall be
applied to chemical substances as actually produced and marketed.
For example, when the Administrator promulgates a rule under sec-
tion 6(a) to regulate a particular substance, such rule will apply to the
identified substance, including all the impurities and other concomitant
products, without explicitly identifying such impurities and con-
comitant products within the rule.

It is expected that the Administrator will develop guidelines for
the purpose of clarifying the extent to which impurities and con-
comitant products will be included within a reference to "chemical
substance" as it relates to the various provisions of the Act. "^^Tiile
impurities and concomitant products are included within references
to a "chemical substance" under the Act, the Administrator is obvious-
ly authorized to move against them separately under the applicable
provisions of the Act.

The term "health and safety study" is important as it describes in-
formation to which various provisions of the Act are applicable. For

671

example, section 8(d) requires manufacturers, processors, and distri-
butors in commerce to list such studies with the Administrator. More-
over, section 14(b) contains provisions concerning the availability of
health and safety studies to the public.

The conference substitute defines health and safety study to mean
any study of any effect of a chemical substance or mixture on health
or the environment, including underlying data and epidemiological
studies, studies of occupational exposure to a chemical substance or
mixture, toxicological. chemical, and ecological studies of a chemical
substance or mixture, and any test performed pursuant to this Act.

It is intended that the term be interpreted broadly. Not only is in-
formation which arises as a result of a formal, disciplined study in-
cluded but other information relating to the effects of a chemcial
substance or mixture on health and the environment is also included.
Any data which bears on the effects of a chemical substance on health
or the environment would be included.

TESTING OF CHEMICAL SUBSTANCES AND MIXTURES

Senate hill {section 4)

Section 4 authorizes the Administrator to require testing of chemi-
cal substances and mixture^s to ascertain potential effects on human
health and the environment. Under subsection (a), the Administrator
must, by rule, require the testing of a chemical substance or mixture it
the Administrator finds (1) that the chemical substance or mixture
may present an unreasonable risk of injury to health or the environ-
ment, or that there may be significant human or environmental expo-
sure because substantial quantities will be produced and such sub-
stance or mixture may perhaps present an adverse effect on health or
the environment ; (2) there are insufficient data or experience to reason-
ably determine or predict its health and environmental effects; and
(By testing is necessary to develop such data. If no reliable data is
available to the Administrator, the finding that such substance or mix-
ture may perhaps present an adverse effect on health or the environ-
ment shall be presumed. In the case of a mixture, the bill requires an

672

additional finding that testing the chemical substances which comprise
the mixture is not a more efficient and reasonable method to determine
effects on health and the environment. When requiring tests under sub-
section (a), the Administrator shall consider reasonably ascertainable
costs and other burdens associated with conducting tests and publish
such considerations in the Federal Kegister.

Subsection (b) sets forth the required contents of the testing rule
and provides an illustrative list of health and environmental effects for
which test standards may be required. This subsection also describes
some of the methodologies which the testing rule may prescribe. In
addition, it describes which manufacturers and processors will be re-
quired to conduct the testing.

The Administrator shall review and, if appropriate, revise the
standards for development of data at least once per year. Testing rules
shall be issued in accordance with the rulemaking procedures of sec-
tion 553, of title 5, United States Code, except that the Administrator
shall allow interested persons the opportunity to make oral presenta-
tions of data, views, or arguments in addition to written submissions.
A transcript of such oral presentations is required.

Subsection (c) provides a procedure whereby persons may apply to
the Administrator for an exemption from a testing requirement rule
in order to avoid submission of duplicative data. If an exemption is
granted, a cost-sharing procedure is provided. A person providing
reimbursement may have access to test data, subject to the confiden-
tiality provisions of section 14.

Subsection (d) requires the Administrator to publish a notice of
receipt of test data in the Federal Register and to make the data
available to the public within 15 days of receipt.

Subsection (e) establishes an interagency advisory committee com-
prised of qualified and appropriate Federal officials to make recom-
mendations to the Administrator regarding testing priorities.

The committee shall submit a list of chemical substances and mix-
tures in the order in which the committee determines the Admin-
istrator should promulgate testing rules under subsection (a). Within
12 months after the inclusion of a chemical on such list, the Admin-
istratx)r shall either initiate a rulemaking proceeding under subsection
(a) or publish reasons for not initiating a proceeding in the Federal
Register. Subsection (e) also contains specific conflict of interest pro-
visions applicable to members of the interagency advisory committee.

Subsection (f) specifies required actions by the Administrator in
response to test data or other information which indicate that a sub-
stance or mixture has a potential to induce cancer, gene mutations, or
birth defects at levels for which human exposure exists or may exist
with appropriate safety margins. The Administrator shall either take
appropi-iate action under section 5 (e) , 6 (a) , or 7 within 180 days after
the date of receipt of such data or information or publish in the Fed-
eral Register a finding that no unreasonable risk of injury is pre-
sented and reasons for making such a finding. Such requirement snail
not take effect until two years after enactment.

House amendment {section 4.)

Like the Senate bill, the House amendment requires that the Admin-
istrator find that there are insufficient data and experience upon which

673

to determine or predict the effects of the manufacture, distribution
in commerce, processing, use, or disposal of a chemical substance or
mixture. It also requires a finding that testing of the substance or
mixture is necessary to develop such data. However, the House bill
differs from the Senate bill in that it requires a finding that a chem-
ical substance or mixture may "cause or significantly contribute" to
an unreasonable risk, whereas the Senate bill requires a finding that
the substance or mixture may "present" an unreasonable risk.

Section 4(a) (1) (B) of the House amendment sets forth a second
set of conditions under which the Administrator shall require testing.
If the Administrator finds (1) (A) that a chemical substance or mix-
ture is or will be produced in substantial quantities; and (B) (i)
either that it enters or may reasonably be anticipated to enter the
environment in substantial quantities or (ii) there is or may be sig-
nificant or substantial human exposure to the substance or mixture,
(2) there is an insufficiency of data, and (3) testing is necessary to
develop the data, the Administrator shall, by rule, require testing.

The House amendment requires the Administrator to consult with
the Director of the National Institute for Occupational Safety and
Health before prescribing epidemiologic studies under the testing re-
quirement rule. The House bill requires the Administrator to make
and publish findings under subsection (a)(1)(A) or (a)(1)(B) before
the issuance of a rule ordering persons to conduct tests. The House
amendment also provides for the expiration of a testing requirement
rule at the end of the reimbursement period.

The House amendment provides for exceptions from the testing rule
in order to avoid submission of duplicative data. If an exemption is
granted, reimbursement requirements similar to those in the Senate
bill apply, except that the reimbursement period may last as long as
five years, instead of the two-year period in the Senate bill. In promul-
gating rules to use in determining fair and equitable reimbursement,
the House amendment does not require the Administrator to consult
with the Attorney General and the Federal Trade Commission.

With respect to the interagency committee's priority list submitted
to the Administrator, the House amendment does not require the Ad-
ministrator either to initiate a rulemaking proceeding or to publish in
the Federal Register the Administrator's reasons for not initiating
such a proceeding. The House amendment does not include the conflict
of interest provisions found in the Senate bill relating to members of
the interagency advisory committee.
Conference substitute {section i)

The conference substitute is similar to the House amendment with
respect to the findings which the Administrator must make m order to
require a manufacturer or processor to test a chemical substance or
mixture, except that the term "presents" is used in heu of "cause or
significantly contribute to". The conference substitute includes this
term throughout the bill when speaking of a risk.

In using the term, the conferees intend that the Administrator be
able to address substances and mixtures which indirectly present un-
reasonable risks, as well as those which directly present such risks.
Further, the conferees do not intend that a substance or mixture must
be the single factor which results in the presentation of the risk.

674

Oftentimes an unreasonable risk will be presented because of the
interrelationsliip or cumulative impact of a number of different sub-
stances or mixtures. The conferees intend that the Administrator have
authority to protect health and the environment in such situations.

In following the House language, the conference substitute requires
testing not only (1) in situations in which a substance or mixture
may present an unreasonable risk, but also (2) in situations in which
there may be substantial environmental or significant or substantial
hum.an exposure to a substance or mixture about which there is inade-
quate information to predict effects on health or the environment.

In the first situation, the conferees intend to focus the Adminis-
trator's attention on those chemical substances and mixtures about
which there is a basis for concern, but about which there is inade-
quate information to reasonably predict or determine their effects on
health or the environment. The Administrator need not show that the
substance or mixture does or will present a risk.

The second situation reflects the conferees' recognition that there
are certain situations in which testing should be conducted even
though there is an absence of information indicating that the substance
or mixture per se may be hazardous.

The conference substitute follows the House amendment with respect
to the contents of the testing rule. The Senate provision concerning
which manufacturers and processors are required to conduct the test-*
ing and submit test data is included. Like both the Senate bill and
the House amendment, the conference substitute permits the Admin-
istrator to gi^ant exemptions from a testing rule. To grant an exemp-
tion, the Administrator must determine whether the chemical sub-
stance or mixture is equivalent to a chemical substance or mixture
for which test data is already being developed. In making this deter-
mination the conferees expect the Administrator to look at any con-
taminants in the chemical substance or mixture for which an exemp-
tion is being sought and ascertain whether any contaminants present
might cause differences in test data which would be significant and
which would, therefore, cause the Administrator to determine that
the chemical substances or mixtures in that instance were not equiva-
lent. It also follows the House amendment concerning reimbursement,
except that the Administrator must consult with the Attorney Gen-
eral and the Federal Trade Commission in issuing rules which estab-
lish the general criteria for determining reimbursement.

The conference substitute retains a modified version of the Senate
provision on the interagency committee which is established to make
recommendations concerning testing priorities to the Administrator.

The Administrator shall provide administrative services to support
such activities. These services shall encompass such things as clerical
staff assistance and supplies. The conferees recognize the importance
of the interagency committee recommendations and expect the inter-
agency committee to deliberate with care; therefore, the conferees
intend that members of the interagency committee shall be given
adequate support services by EPA. They also shall be relieved of
responsibilities within the entity they represent to the extent necessary
to carry out their duties to the committee. Each entity represented
shall provide its member with professional and research services. Here,

675

as in all places in the bill where specific officers of the Federal Govern-
ment are referred to by title, the conferees intend that such references
be construed to mean successors to such offices as affected by any re-
organization plan or the like.

The interagency committee may designate a maximum of 50 sub-
stances or mixtures with respect to which the Administrator should
initiate a testing rulemaking proceeding within a year. Xo more than
50 substances or mixtures may be so designated at any one time. If the
Administrator does not take such action within a year, the Adminis-
trator must publish in the Federal Kegister an explanation as to why
such action has not been taken.

The conferees have given discretion to the interagency committee
as to how many substances or mixtures should be designated. Al-
though the committee may designate up to 50 substances or mixtures
at any one time, the conferees wish to stress that the committee
need not designate the maximum number. While it is intended that
the recommendations of the interagency committee be given great
weight by the Administrator, it should be emphasized that the decision
to require testing rests with the Administrator.

The conferees do not intend that, in complying with the require-
ments of the statute, the Administrator divert from the regulatory
activities of the Agency an inordinate amount of resources to justify
the failure to require testing.

If the Administrator receives information which indicates to the
Administrator that there may be a reasonable basis to conclude that
a substance or mixture presents or will present a significant risk of
serious or widespread harm to human beings from cancer, gene muta-
tions, or birth defects, the Administrator shall initiate appropriate
action under section 5, 6, or 7 to protect against the risk or publish
in the Federal Register a finding that the risk is not unreasonable.
Such action must be taken within 180 days of the receipt of the data,
except that the Administrator may extend that period for an addi-
tional 90 days for good cause. This requirement does not take effect
until two years after the date of enactment.

The conference substitute adopts a provision contained in the House
amendment which enables any person who intends to manufacture or
process a chemical substance which is not subject to a rule under sec-
tion 4(a) to petition the Administrator to prescribe standards for the
development of test data for such substance. The Administrator must
grant or deny the petition within sixty days. If the petition is granted,
the Administrator shall prescribe such standards within seventy-five
days of the date on which the petition is granted. Any denial of such
a petition must be published in the Federal Register.

MANUFACTURING AND PROCESSING NOTICES

Senate till {section 5)

The Senate bill requires any manufacturer of a new chemical sub-
stance to notify the Administrator at least ninety days prior to the
commencement of commercial manufacture of the new substance. The
notice is to inckide the common and the trade name of the substance, its
chemical identity and molecular structure, categories or proposed cate-

676

gories of use, reasonable estimates of the amount to be manufactured or
processed, a description of the by-products, estimates of the number of
people who will be exposed to the substance in their places of em-
ployment, and existing data concerning environmental and health
effects of the substance.

In addition, if a testing rule applicable to the substance is in
effect prior to submission of the notice, the manufacturer is required
to submit along with the notification, the test data required to be de-
veloped by the testing rule.

The ninety day notification period may be extended by the Admin-
istrator for an additional ninety days for good cause shown. Notice
of such extension must be published in the Federal Kegister.

Similar notification is required of any person intending to manu-
facture or process a chemical substance for a distribution in commerce,
use, or disposal that has been identified by the Administrator, by rule,
as a significant new use, distribution, or disposal. The Administrator is,
by rule, to establish criteria defining a significant new distribution in
commerce, use, or disposal. In establishing such criteria, the Adminis-
trator is to take into account the projected volume of production and
category or categories of uses, increases in magnitude and duration of
human or environmental exposure, routes of exposure, and the human
health and environmental effects.

The Senate bill authorizes the Administrator to issue immediately
effective administrative orders during the notification period to halt
or limit the manufacture, processing, distribution in commerce, use
or disposal of new chemical substances subject to the notification re-
quirements in two situations.

First, the Administrator is required to issue such an order if the
Administrator finds that a testing requirement under section 4 (a)
should be established or modified. The order is to remain in effect
until an expedited rulemaking proceeding under section 4(a) to re-
quire testing can be completed, the testing performed and the test data
submitted. Second, if the Administrator finds that a new substance
presents or is likely to present an unreasonable risk of injury to health
or the environment, the Administrator is also required to issue an im-
mediately effective order. If such an order is issued, the Administra-
tor must conduct an expedited rulemaking proceeding in accordance
with the provisions of secti9n 6(c) (2) and (3).

If the Administrator does not take action to prohibit or limit the
manufacture, processing, distribution in commerce, use or disposal of
a new substance during the notification period, the Administrator is
required to publish a statement of reasons in the Federal Register for
not taking such action. The statement must be published prior to the
expiration of the notification period. Manufacture or processing of the
new substance may commence following publication of the Admin-
istrator's statement. Failure to take action against a substance is an
action subject to judicial review.

The Senate bill provides certain exemptions from the requirement
to submit manufacturing and processing notice. The Administrator is
authorized to grant such an exemption for test marketing or other
specially limited purposes. In addition, the Administrator may
exempt chemical substances which are intermediate reaction products

677

formed during the manufacture of another chemical substance and
to which there is no human or environmental exposure. In addition,
the notification provisions of the Senate bill do not apply to any
chemical substance manufactured in small quantities solely for scien-
tific experimentation or analysis or for chemical research or analysis,
including such research or analysis for the development of a product.
However, the Administrator may, by rule, require notification prior
to the manufacture or processing of such a substance upon a finding
that the substance may cause or contribute to an unreasonable risk of
injury to health or the environment. Although the section, by its
terms, does not apply to mixtures, the Administrator is authorized to
specify any mixture which shall be subject to the provisions of the
section.

House amendment {section 6)

Like the Senate bill, the House amendment requires manufacturers
of new chemical substance to notify the Administrator ninety days
prior to the commencement of commercial manufacture of such new
substance. The notice is to include information similar to that re-
quired by the Senate bill, including test data required to be developed
by any applicable testing rule which has been promulgated under
section 4 prior to the submission of the notice.

In addition, the House amendment rexjuires the Administrator to
compile and maintain a list of chemical substances which cause or
significantly contribute to or may cause or significantly contribute to
an unreasonable risk to health or the environment. If a person intends
to manufacture a new chemical substance included on this list and
if no testing rule applicable to the substance has been issued under
section 4, the person must submit to the Administrator information
which the person believes indicates that the chemical substance will
not cause or significantly contribute to an unreasonable risk. Such in-
formation must be submitted along with the notice.

The House amendment also requires manufacturers or processors of
an existing chemical substance for a new use which has been des-
ignated by the Administrator, by rule, as a significant new use, to
provide similar notice ninety days prior to such manufacture or proc-
essing. The House amendment does not require notification prior to
the manufacture or processing of a chemical substance for a signifi-
cant new distribution in commerce or disposal.

In instances in which there is inadequate information to evaluate
the effects of a new substance or of an existing substance for a signifi-
cant new use, the Administrator is authorized to seek a court in-
junction to halt manufacture, processing or distribution in commerce.
The Federal district courts are empowered to grant injunctions if the
court finds that (1) there is inadequate information to reasonably
evaluate the health and environmental effects of the new substance and
(2) in the absence of such information, the substance may cause or
significantly contribute to an unreasonable risk. If an injunction is
granted, the Administrator shall conduct an expedited rulemaking
proceeding to determine if a lesser restriction (rather than a total
halt of manufacture, processing or distribution) would be adequate
to protect health or the environment until adequate test data is devel-
oped and evaluated.

678

The House amendment does not require the Administrator to
publish a statement of reasons for not taking action during the
notification period to prohibit or limit the manufacture, processing,
distribution, use or disposal of a new substance or of an existing sub-
stance manufactured or processed for a significant new use.

The House amendment also provides for exemptions from the noti-
fication requirements. The Administrator is authorized to provide an
exemption for the manufacture and processing of a substance for test
marketing purposes. The House bill specifically exempts from the
notification requirements those chemical substances manufactured or
processed in small quantities for scientific experimentation or analysis
or for chemical research or analysis on such substance or another sub-
stance, including research and analysis for the development of a sub-
stance or another substance into a commercial product. However, all
persons engaged in such experimentation, research or analysis for a
manufacturer or processor must be notified of any risk to health which
the manufacturer or processor has reason to believe may be associated
with the substance.

The House amendment authorizes the Administrator, by rule, to
exempt a manufacturer or processor of any new chemical substance
from all or part of the requirements of this section if the Administrator
determines that such chemical substance will not cause or signifi-
cantly contribute to an unreasonable risk to health or the environ-
ment. The Ho8se amendment also contains an exemption clarifying
that a chemical substance which, except for its inert ingredients, is
identical to a chemical substance contained on the section 8(b) inven-
tory will not be treated as a new chemical substance.

The House amendment does not authorize the Administrator to spec-
ify that a manufacturer of a mixture shall be subject to the notifica-
tion requirements.

Conference substitute (section 5)

In general. — Section 5 sets out the notification requirements with
which manufacturers of new chemical substances and manufacturers
and processors of existing substances for significant new uses must
comply. The requirements are intended to provide the Administrator
with an opportunity to review and evaluate information with respect
to the substance to determine if manufacture, processing, distribution
in commerce, use or disposal should be limited, delayed or prohibited
because data is insufficient to evaluate the health and environmental
effects or because the substance or the new use presents or will present
an unreasonable risk of injury to health or the environment.

The provisions of the section reflect the conferees recognition that
the most desirable time to determine the health and environmental
effects of a substance, and to take action to protect against any poten-
tial adverse effects, occurs before commercial production begins. Not
only is human and environmental harm avoided or alleviated, but the
cost of any ro<rulatory action in terms of loss of iobs and capital in-
vestment is minimized. For these reasons the conferees have given the
Administrator broad authority to act during the notification period.

Any person who intends to manufacture a new chemical substance
or manufacture or process a chemical substance for a use which the
Administrator, by rule, has determined is a significant new use, must

679

give the Administrator at least 90 days notice before beginning such
manufacture or processing, The 90-day period shall begin upon re-
ceipt of the notice by the Administrator or the Administrator's duly
designated representative.

The conferees have not included the Senate provision which requires
notification of significant new distributions or disposals. However,
the conference substitute requires that the Administrator consider
the reasonably anticipated manner and method of manufacturing,
processing, distribution in commerce and disposal of a substance in
determining when a use will be considered a significant new use. Thus,
the conferees intend that any potential threats to health or the en-
vironment from the manufacture, processing, distribution in com-
merce, or disposal of a substance associated with a new use be con-
sidered by the Administrator when determining the significance
of a new use. In addition, the Administrator shall consider the
projected volume of manufacturing and processing of the substance
for a use, the extent to which a use changes the type or form of ex-
posure of human beings or the environment to a substance, and the
extent to which such use increases the magnitude and duration of
human or environmental exposure to a substance. Thus, a significant
increase in thj projected volume of manufacture or processing for a
substance, a significant change in the type or form of human or en-
vironmental exposure, or a significant increase in the magnitude or
duration of human or environmental exposure could be the basis for
determining that a use is a significant new use.

Submission of test data. — Subsection (b) describes the instances in
which a person subject to a notification requirement with respect to a
chemical substance under subsection (a) must submit test data to
the Administrator before manufacture of the substance or manufac-
ture or processing of the substance for a significant new use can begin.
If a rule under section 4 respecting a substance has been promul-
gated before submission of the notice required by subsection (a),
then a person who is required by the section 4 rule to submit test data
for the substance must submit 'such test data at the time the notice
is submitted in accordance with subsection (a). This assures that the
Administrator will have at least 90 days to evaluate the test data be-
fore the manufacture or processing begins. If a person has been
granted an exemption from a testing rule under section 4 applicable
to a new substance or to a significant new use of an existing substance,
such person shall not begin manufacture or processing until 90 days
after the date of submission of the test data on which the exemption
is based.

It should be noted that if a testing rule under section 4 respecting
a substance has not been promulgated prior to the submission of a
notice required by section 5, the Administrator may promulgate a
testing rule under section 4 for such substance without taking sepa-
rate action under this section. However, such a rule would not delay
the manufacture or processing of the substance.

The conferees adopted a provision from the House bill to insure
that information respecting the health and environmental effects of
any chemical substance which the Administrator has identified as a sus-
pect chemical substance is submitted at the time of notification. Under

680

the conference substitute the Administrator may, by rule, compile a list
of chemical substances the manufacture, processing, distribution in
commerce, use or disposal of which presents or may present an unrea-
sonable risk of injury to health or environment. If a testing rule under
section 4 has not been promulgated with respect to such substance
before the submission of the notice, then the person submitting the
notice must submit to the Administrator data which the person believes
shows the manufacture, processing, distribution in commerce, use and
disposal of the substance or any combination of such activities will
not present an unreasonable risk to health or the environment.

Extension of notice period. — The Administrator, for good cause,
may extend the 90 day notification period for additional periods not to
exceed in the aggregate 90 days. Notice of any extension together with
the reasons for it shall be published in the Federal Register and shall
constitute final agency action subject to judical review.

The conferees intend that the Administrator have a large degree of
flexibility in extending the notification period, so that manufacture or
processing may begin as soon as the Administrator has sufficient
information to evaluate the substance. For example, if the Administra-
tor expects that sufficient data will be available 30 days after the origi-
nal notification period will expire, then the conferees expect that the
Administrator will settle on an extension period which will reasonably
accommodate production of that data and time for administrative con-
sideration. If production of the data is delayed, of course the Admini-
strator may extend the original extension period. However, in.no case
may the extensions exceed a total of 90 days. Every time that the
notification period is extended, the Administrator must publish notice
of the extension in the Federal Register along with reasons therefor.

Content of notice; publicatioms in the Federal Register. — The con-
ference substitute requires the notice required under subsection (a) to
include certain information described in section 8(a) (Reporting and
Retention of Information) whether or not the Administrator has
required its submission under that section ; any test data in the posses-
sion or control of the person giving the notice which is related to the
effects on health or the environment of any manufacture, processing,
distribution in commerce, use or disposal of the substance ; and a de-
scription of any other data concerning the health and environmental
effects of the substance, insofar as known to the person making the
report or insofar as reasonabl;/ ascertainable. The notice shall be made
available, subject to section 14, for examination by interested persons.

In order that the public receive timely notification of any new
chemical substance or any significant new use of an existing chemical
substance, the conference substitute includes a provision which requires
the Administrator to publish in the Federal Register a notice which
identifies the chemical substance, lists the uses or intended uses of the
substance, and describes the nature of tests performed on such sub-
stance and any data developed pursuant to subsection (b) or a rule
under section 4. Such publication must occur within 5 days after the
Administrator receives notice from the person who intends to manu-
facture or process.

The conference substitute also requires the Administrator to publish
monthly a list of each chemical substance for which notice has been

681

received under subsection (a) and for which the notification period
has not expired. The Administrator must also include on the list those
substances for which the notification period has expired since the last
monthly publication.

Regulation pe'iiding development of information. — Subsection (e)
sets out the procedures under which the Administrator can halt or limit
the manufacture, processing, distribution in commerce, use, or disposal
of a new substance or an existing substance for a significant new use
when there is insufficient information to evaluate the health and en-
vironmental effects of the substance.

Action to prohibit or limit manufacture, processing, distribution in
commerce, use, or disposal is required in instances in which the Admin-
istrator determines that :

(1) Information available to the Administrator is insufficient to
permit a reasoned evaluation of the health and environmental ef-
fects of the substance, and

(2) (a). In the absence of information sufficient to permit the
Administrator to make such an evaluation, the manufacture, proc-
essing, distribution in commerce, use, or disposal of the substance
may present an unreasonable risk of injury to health or the
environment, or

(b) . The substance is or will be produced in substantial quanti-
ties, and (i) enters or may reasonably be anticipated to enter the
environment in substantial quantities or (ii) there is or may be
significant or substantial human exposure to the substance.
If the Administrator makes the above determination at least 45 days
before the expiration of the notification period, then the Administrator
may issue a proposed order to prohibit or limit the manufacture, proc-
essing, distribution in commerce, use or disposal of the substance. A
limitation on manufacture or processing could, of course, include a
labeling requirement. The proposed order will take effect upon the
expiration of the notification period unless the manufacturer or proc-
essor subject to the order files objections with the Administrator,
specifying with particularity the provision of the order deemed objec-
tionable and stating the grounds for the objection. To prevent the
order from becoming effective, the objections must be filed within 30
days after the manufacturer or processor has received in writing from
the Administrator a notice of the proposed order. The conferees wish
to stress that the Administrator must provide actual notice in writing
to the manufacturer or processor who will be subject to the order.
Notice is not to be published in the Federal Register, but is, of course,
available to the public if it is not prohibited from disclosure under
section 14.

This provision thus represents a melding of the Senate bill and the
House amendment. In order to insure that timely action may be taken
by the Administrator, the conference substitute authorizes the Admin-
istrator to issue an administrative order to take effect immediately
upon the expiration of the notification period. However, to protect
against unilateral action by the administrator without an adequate
basis for action, the conference substitute borrows the procedure from
section 701 (^) of the Federal Food, Drug, and Cosmetic Act which
permits the filing of objections by manufacturers and processors spe-

79-313 O - 77 - 44

682

cifying with particularity the provisions of the order deemed objec-
tionable and stating the grounds for the objections.

If such objections are filed, then the Administrator is instructed to
seek an injunction in a Federal district court to prohibit or limit the
manufacture, processing, distribution in commerce, use or disposal of
the substance. Of course, if the objections filed with the Administrator
indicate to the Administrator that the injunction is not necessary,
then the Administrator is not required to seek the injunction.

If the court finds in such injunction action that (1) information
available to the Administrator is insufficient to permit a reasoned
evaluation of the health and environmental effects of the substance,
and (2) (A) in the absence of such information, the manufacture, proc-
essing, distribution in commerce, use, or disposal of the substance may
present an unreasonable risk of injury to health or the environment
or (B) such substance is or will be produced in substantial quantities
and it enters or may reasonably be anticipated to enter the environ-
ment in substantial quantities or there is or may be significant or sub-
stantial human exposure to the substance, then the court shall grant
an injunction. The conferees intend that this two-part standard totally
supplant the traditional elements which a party must ordinarily show
before a court will exercise its equitable jurisdiction to grant an in-
junction. The conferees do not intend that the Administrator be re-
quired to make any showing other than that which is required for the
court to make the two findings described above. Application of any
other standard by the court would frustrate the purposes of this sec-
tion that suspect chemicals be adequately tested to determine their
health and environmental effects before commercial manufacture or
processing begins.

The conference substitute authorizes such courts to grant a
temporary restraining order or a preliminary injunction to prohibit
manufacture, processing or distribution of a new substance or of an
existing substance for a significant new use if the court finds that
the notification period may expire before the action for an injunction
can be completed. The conferees recognize that a manufacturer or
processor, merely by beginning to manufacture, process, or distribute
a new chemical or an existing chemical for a significant new use,
could defeat the objective of section 5 to totally prevent environ-
mental or human exposure to suspect new chemical substances or sig-
nificant new uses of existing chemical substances until adequate testing
can be performed and the data evaluated. Therefore, the conferees in-
tend that the court freely exercise the authority to grant preliminary
relief as is necessary to preserve the status quo in order to insure that
the policy of this section can be fulfilled.

After submission of adequate test data to the Administrator and
evaluation of such data, the district courts may, upon petition, dis-
solve the injunction unless the Administrator has initiated a proceed-
ing under section 6(a) with respect to the substance. In such a situ-
ation, the injunction shall remain in effect until the effective date of a
rule under section 6(a) or until the section 6 proceeding is terminated,
whichever occurs first.

Protection against unreasonable risk. — Section 5(f) of the con-
ference substitute requires the Administrator to take immediate action

683

to prohibit or limit human or environmental exposure to a new chem-
ical substance or to an existing chemical substance for a significant
new use in certain situations. In section 5(f) the conference substitute
authorizes the Administrator to issue a proposed rule under section
6(a), but such rule is to be effective upon its publication in the Fed-
eral Register. Such action is authorized in instances in which there
is a reasonable basis to conclude that the manufacture, processing, dis-
tribution in commerce, use, or disposal of the substance presents or will
present an unreasonable risk of injury to health or the environment
before a rule promulgated under section 6(a) could protect against
the risk. The conferees recognize, of course, that there is authority in
section 6(d) under which the Administrator may make a proposed
section 6(a) rule immediately effective. However, to invoke the section
6(d) authority the Administrator must find an imminent, unreason-
able risk of serious or widespread injury. With respect to new chemi-
cal substances or substances for significant new uses, immediate action
is authorized under section 5(f) when there is an imminent, unreason-
able risk of injury, regardless of whether the injury will be serious or
widespread.

The section 6(a) rule proposed and made immediately effective pur-
suant to the authority of this section may (A) limit the amount of a
substance which may be manufactured, processed, or distributed in
commerce, (B) cont in anv of the i*equirements described in para-
graph (2), (3), (4), (5). (6), or (7) of subsection 6(a), or (C) con-
tain any combination of the requirements described in clauses (A) and
(B). Immediately following the publication in the Federal Register
of a section 6(a) rule as authorized by this section, the Administrator
must conduct an expedited rulemaking proceeding in accordance with
the provisions of section 6(d) (2).

A rule under section 6(a) authorized by this section may not totally
prohibit the manufacture, processing, or distribution in commerce of
a new substance or an existing substance for a significant new use.
In order to totally prohibit the manufacture, processing, or distribu-
tion in commerce of a new substance, or of an existing substance for a
significant new use, the Administrator must either issue a proposed
order which. shall be subject to all the procedures applicable to the
situation when there is an insufficiency of information, as described
above, or obtain a court injunction. If the court finds that there is a
reasonable basis to conclude that the manufacture, processing, distri-
bution in commerce, use or disposal of a new substance or of an existing
substance for a significant new use presents or will present an un-
reasonable risk of injury to health or the environment, the court shall
issue an injunction. Again, the conferees intend that the court will
not use the normal equity standard to determine if an injunction should
be issued. Instead, the standard set out in section 5(f) (3) (B) of the
conference substitute is intended to totally replace the normal injunc-
tion standard.

The conferees recognize that there will be instances in which there
are a limited number of practical uses for a chemical substance and
that bv issuing an immediatelv effective proposed rule prohibiting
those uses, tlie Administrator could effectively prohibit manufacture
or processing altogether. The conferees vicAv such a prohibition as a

684

total prohibition of manufacture or processing and intend that the
Administrator comply with the procedures of section 5 (f ) (3) in
order to obtain a total prohibition on manufacture or processing. The
authority to issue an immediately effective rule to prohibit manufac-
ture or processing for a use should be utilized only when there is more
than one practical use of a substance and when the prohibition does
not effectively ban all such uses. Likewise, the conferees do not intend
that the Administrator utilize the authority to issue an immediately
effective proposed rule so severely limiting the amount of a substance
which may be manufactured, processed, or distributed in commerce
as to effectively prohibit manufacture, processing, or distribution.

Statement of reasons for not taking action. — If, within the notifica-
tion period, the Administrator has not initiated action under this sec-
tion or section 6 or 7 to prohibit or limit the manufacture, processing,
distribution in commerce, use or disposal of certain new chemical sub-
stances or of existing chemical substances for significant new uses, then
subsection (g) requires the Administrator to issue a statement of rea-
sons in the Federal Register for not initiating such action. The state-
ment must be published prior to the expiration of the notification
period. The chemical substances for which such a statement is required
are those for which the Administrator, because of prior administrative
action with respect to such chemical substances, has indicated there
may be particular cause for concern. Specifically, a statement of reasons
for not initiating action is required if a testing rule under section 4
applies to a new substance or an existing substance for a significant
new use, or if a substance is listed under section 5(b) (4). In addition,
if notification is required because a use constitutes a significant new use
and, if no action is initiated during the notification period, the Admin-
istrator must issue a statement of reasons for not initiating such action.

Publication of the statement of reasons in accordance with this sub-
section is not a prerequisite to the manufacture or processing of the
substance with respect to which the statement is to be published. Thus,
the Administrator, merely by not issuing the statement of reasons,
cannot delay the beginning of manufacture or processing of a new
substance or a substance for a significant new use. Nonetheless, the
Administrator must perform this non-discretionary duty and will
subject himself not only to criticism by the Congress for not doing so,
but may also subject himself to suit under section 20 of this Act or
other provisions of law relating to the required performance of non-
discretionary duties.

Exemption.s. — Subsection (h) describes the situations in which a
chemical substance may be manufactured or processed without regard
to the notice and test data submission requirements of subsections (a)
and fb). Paragraph (1) provides the authority for granting an ex-
emption for test marketing purposes. Under paragraph (2) an
exemption from the test data submission requirements of subsection
(b) may be obtained if submission of data for the substance to be
exempted would be duplicative of data already submitted to the
Administrator. Paraqrraph (3) adopts the lantruag-e in the House
amendment specifically exemptins: from the notification requirements
those chemical substances manufactured or processed or proposed to
be manufactured or processed in small quantities (as defined by the

685

Administrator by rule) for scientific experimentation or analysis or
for chemical research or analysis, including research and analysis for
the development of the substance or another chemical substance into
a commercial product. All persons engaged in such experimentation,
research, or analysis for a manufacturer or processor must be notified
or any risk to health which the manufacturer or processor or Admin-
istrator has reason to believe may be associated with the substance.

Under paragraph (4) , the Administrator may, upon application and
by rule, exempt the manufacturer of a new chemical substance from
all or part of the requirements of this section if the iVdministrator de-
termines that the manufacture, processing, distribution in commerce,
use or disposal of the substance will not present an unreasonable risk
of injury to health or the environment. A rule granting such an exemp-
tion must be promulgated in accordance with paragraphs (2) , (3) , and
(4) of section 6(c).

Paragraph (5) authorizes the Administrator to make the require-
ments of subsection (a) and (b) inapplicable with respect to the man-
ufacture or processing of a chemical substance which may temporar-
ily exist as a result of a chemical reaction in the manufacture or proc-
essing of a mixture or another chemical substance and to which there
is not or will not be anj human or environmental exposure.

The conference substitute deletes the provision in the House amend-
ment which clarified that a chemical substance is not to be treated as a
new chemical substance solely because of the change in proportions of
inert ingredients. This provision of the House amendment was deleted
because under the definition of "mixture" in section 3 of the conference
substitute the same result would occur, as any change in inert ingre-
dients would constitute a new mixture not a new chemical substance.
Mixtures are not covered by section 5.

Definition. — The terms "manufacture'' and "process" as used in this
section mean to manufacture or to process for commercial purposes.
Since the tenn "manufacture" is defined to include import, persons who
intend to import substances for commercial purposes will be treated
in the same manner as domestic manufacturers under section 5.

REGULATION OF CHEMICAL SUBSTANCES AND MIXTURES

'Senate hill (section 6)

The Senate bill requires the Administrator to impose restrictions on
a chemical substance or mixture if the Administrator finds that the
manufacture, processing, distribution in commerce, use, or disposal
presents or is likely to present an unreasonable risk of injury to health
or the environment. The Administrator shall impose one or more of
several specified requirements as is necessary to adequately protect
against the risk, using the least burdensome of effective controls.

A range of requirements is provided, from complete prohibitions on
the manufacturing, processing, or distribution in commerce to labeling
requirements. Among these is the authority to regulate the manner of
method of use or disposal of such substance or mixture and the author-
ity to require manufacturers or processors to replace or repurchase
substances o?* mixtures found to present unreasonable risks.

The Senate bill also contains the authority to limit the amount of a
substance or mixture which may be manufactured, processed, or dis-

686

tributed in commerce, or which may be manufactured, processed, or
distributed in commerce for a particular use. A procedure for assign-
ing permissible quotas if the applicable parties are unable to agree is
provided. Supervision by the Attorney General and the Federal Trade
Commission is provided for any voluntary efforts to establish quotas.

The Senate bill authorizes the Administrator to order manufacturers
or processors to submit descriptions of relevant quality control proce-
dures if the Administrator has good cause to believe that the manufac-
ture or processing causes the adulteration of a chemical substance or
mixture. If the Administrator determines that the quality control pro-
cedures of the manufacturer or processor are inadequate, the Adminis-
trator may order revisions in the quality control procedures to the
extent necessary to remedy the inadequacy.

The Senate bill also requires the Administrator to consider relevant
factors in imposing restrictions and to make findings with respect to
certain factors.

The Senate bill contains a specific rulemaking procedure for rules
imposing restrictions under this section. The procedure is an informal
one, similar to the procedures in section 553 of title 5, United States
Code, but there are exceptions, including an opportunity for an infor-
mal hearing. An opportunity for appropriate cross-examination in the
hearing is provided under the supervision of the Administrator. Par-
ticipants in a rulemaking proceeding may be compensated by the
Administrator under specified criteria.

The Administrator may specify the date on which a rule under this
section becomes effective, which shall be as soon as administratively
feasible.

The Administrator may waive the required notice and comment
period in those situations where compliance with the rulemaking pro-
visions would present an unreasonable risk of death, serious or sub-
stantial personal injury, or serious or substantial environmental harm.

Finally, the Senate bill provides for the control of polychlorinated
biphenyls (PCBs). Effective one year after the date of enactment of
the Act, PCBs may not be used in any manner other than a totally en-
closed manner, except that the Administrator may, by rule, authorize
exceptions if the Administrator finds that no unreasonable risk of
injury to health or the environment is presented. Effective two
years after the date of enactment, the manufacture of any polychlo-
rinated biphenyl Avould become unlawful. Effective two and one-half
years after such date, the processing or distribution in commerce of
PCB's would become unlawful, except that the Administrator may
make exceptions if no unreasonable risk of injury to health or the
environment is presented. Disposal regulations concerning PCB's
shall be promulgated within six months after the date of enactment.

House amendment {section 6)

The standard for taking action against unreasonable risks under this
section in the House amendment is slightly different from that con-
tained in the Senate bill. If the Administrator finds that there is a
reasonable basis on which to conclude that the manufacture, process-
ing, distribution in commerce, use, or disiX)sal of a chemical substance
or mixture, or any combination of such actions causes or significantly
contributes to, or will cause or significantly contribute to, an unrea-

687

sonable risk to health or the environment, the Administrator shall
impose requirements as necessary to protect against the risk. The re-
quirements generally are similar to the requirements of the Senate bill,
with several exceptions. The Administrator may not regulate the man-
ner or method of use. Nor may the Administrator impose replacement
or repurchase requirements for substances regulated. Requirements
regulating the manner or method of disposal may not require any
person to take an action in violation of a State or local law. Also, a
person subject to a disposal requirement shall notify the State in
which a required disposal may occur of such requirement. The House
amendment does not contain authority to impose manufacturing or
processing quotas.

The House amendment provides a procedure for protecting against
unintentional contamination of a chemical substance due to the manner
of manufacturing or processing. Quality control procedures may be
required to be submitted. If found inadequate, the Administrator may
order such procedures to be changed. In addition, if the quality con-
trol procedures have resulted in the distribution in commerce of sub-
stances or mixtures which cause or significantly contribute to an un-
reasonable risk to health or the environment, the Administrator may
require manufacturers or processors to give notice and to replace or
repurchase any such substance or mixture as is necessary to protect
health or the environment.

In promulgating any rule under section 6(a), the Administrator
shall consider all relevant factors and make findings with respect to
certain factors.

The Administrator shall not promulgate a rule under this section
if the risk could be eliminated or reduced to a sufficient extent under
another federal law administered by the Administrator unless the
Administrator makes a finding that it is in the public interest to do so,
taking into consideration a number of enumerated factors.

The rulemaking procedures of the House amendment are generally
similar to those contained in the Senate bill.

The Administrator may make a rule immediately effective if an un-
reasonable risk of serious or widespread liarm to health or the environ-
ment will occur prior to the completion of the rulemaking proceedings,
and making the nile so effective is necessary to protect the public in-
terest. If a proposed rule totally prohibits the manufacture, process-
ing or distribution of a chemical substance or mixture, a court must
have previously taken action against a substance or mixture in an im-
minent hazard' proceeding under section 7. An expedited rulemaking
procedure is provided for immediately effective rules.

The provision of the House amendment relating to PCBs is similar
to the Senate bill with a few exceptions. For example, the prohibitions
effective in one year apply only to the manufacture, processing or dis-
tribution in commerce for a use other than a use in a totally enclosed
manner. In addition, exemptions from the prohibitions relating to
the manufacture, processing, and distribution of PCB's may be
granted, if the Administrator determines that the exemption is neces-
sary to protect health or the environment, and good faith efforts have
been made toxievelop substitutes.

688

Conference substitute {section 6)

The conference substitute requires the Administrator to take action
under this section against chemical substances or mixtures for which
there is a reasonable basis to conclude that the manufacture, process-
ing, distribution in commerce, use, or disposal of such chemical sub-
stances or mixtures, or any combination of such activities, presents or
will present an unraasonable risk of injury to health or the environ-
ment. Requirements shall be imposed to the extent necessary to protect
against the risk.

The requirements must be the least burdensome feasible for those
subject to the requirement and for society while providing for an ade-
quate margin of protection against the unreasonable risk.

The requirements which may be imposed are similar to those in-
cluded in both the Senate bill and the House amendment. The Ad-
ministrator may impose requirements regulating the manner or method
of the commercial use of a substance a mixture and also requirements
regulating the manner or method of disposal of a substance or mix-
ture or an article containing a substance or mixture by the manu-
facturer or processor or by any other person who uses or disposes of it
for commercial purposes. The provision of the House amendmnt that
a disposal requirement may not require any person to take action in
violation of any State law or political subdivision is included. The
conference substitute also includes the Senate provision which author-
izes the Administrator to require replacement or repurchase by manu-
facturers or processors of substances or mixtures with respect to which
action has been taken under this section.

The provisions of the House bill relating to quality control are
included.

The provisions of the Senate bill which authorize the Administra-
tor to assign manufacturing or processing quotas are not included.

Tlie conferees appreciate that if the Administrator chooses to im-
pose a production limitation on any chemical substance, such limita-
tion, if not carefully drawn, could produce monopoly profits. The
conferees believe that the Administrator should consult with the At-
torney General and the Federal Trade Commission in order to avoid
any anticompetitive consequences.

iThe conference substitute requires the Administrator to consider
certain enumerated factors and to publish a statement in the Federal
Register with respect to them at the time of promulgation of a rule
under section 6(a). Specifically, the Administrator must consider and
publish a statement concerning the effects of the substance or mixture
on health and the magnitude of human exposure to such substance or
mixture ; the effects of the substance or mixture on the environment
and the magnitude of environmental exposure to such substance or
mixture; the benefits of such substance or mixture for various uses
and the availability of substitutes for such uses; and the reasonably
ascertainable, economic consequences of the rule, after considera-
tion of the effects on the national economy, small business, innovation,
the environment, and the i^ublic health. This requirement was con-
tained in both the Senate bill and the House amendment. The purpose
in requiring such a stat-ement is to assure that the basis for the Admm-
istrator s rule are publicly enumerated. By requiring the statements,

689

the conferees intend to empliasize key considerations which must be
addressed. The conferees do not intend that the statement be detailed
or voluminous. A succinct and precise statement of these key con-
siderations will suffice. Of course, the statements will provide part
of the rulemaking record for judicial review of a rule promulgated
under section 6(a).

Moreover, if the Administrator determines that a risk may be elim-
inated or reduced to a sufficient extent by actions taken under an-
other Federal law administered by the Administrator, action may not
be taken under this section unless the Administrator finds, in the
Administrators discretion, that it is in the public interest to take
action under this Act. By committing such determination to the Ad-
ministrator's discretion, the conferees intend that such determination
not be subject to judicial review.

The House provision relating to compensation for the costs of par-
ticipating in a rulemaking proceeding and the provisions relating to
the effective date of a rule are included. Generally rules are to be ef-
fective as soon as procedurally and administratively feasible. How-
ever, proposed rules may be declared to be immediately effective by the
Administrator in certain instances. The rule may be declared immedi-
ately effective if the Administrator determines that the manufacture,
processing, distribution in commerce, use, or disposal of a substance
or mixture is likely to result in an unreasonable risk of serious or
widespread injury to health or the environment before the normal ef-
fective date and making the rule immediately effective is necessary to
protect the public interest. In the case of a rule to prohibit the manu-
facture, processing, or the distribution, a court must have granted
relief in an imminent hazard action under section 7. An expedited rule-
making procedure is ]:>rovided if a rule is made immediately effective.

The conference substitute includes procedures contained in both
bills for prescribing rules. In general, rules under this section are to be
prescribed in accordance with the informal rulemaking procedures of
section 553 of title 5, United States Code, except that an opportunity
for an oral hearing and for limited cross-examination is provided. The
procedures are patterned after those contained in section 18 of the
Magnuson-]Moss Warrantv-Federal Trade Commission Improvements
Act.

The Senate bill, unlike the House amendment, specifically authorizes
the Administrator to conduct cross-examination on behalf of the par-
ticipants to the proceeding. Although the conference substitute retains
the Senate provision, the conferees expect that in most instances the
participants themselves would conduct the cross-examination, subject
to the Administrator's time limitations and other rules.

Allien the Act states that the transcripts sliall be available to^ the
public, the conferees intend that such availability be construed in a
reasonable manner. Xo person may be denied access to such informa-
tion, but at the same time the Administrator shall not be required to
assume the burden of copving what may be a formidable amount of
material. Therefore, the conferees intend that the Administrator fur-
nish copies of transcripts as long as a supply exists within EPA. How-
ever, if the antount of material is vast, or if EPA has run out of copies,
then the person mav inspect the transcript which shall be available at
every regional office of EPA. EPA may photocopy a reasonable num-

690

ber of pages, such as 200, but shall in all cases afford any person the
opportunity to photocopy as much of the transcript as the person de-
sires. The cost of copying pages beyond a reasonable number shall be
borne by the person ; however, the Administrator shall not charge an
unreasonable fee per page.

Generally, the provisions of the Senate bill relating to the control of
polychlorinated biphenyls are included. The standard that must be
satisfied before exemptions from the complete ban on polychlorinated
biphenyls are granted contains elements of both the House and Senate
provisions. Exemptions may be granted only if the Administrator
finds that there is no unreasonable risk to health or the environment,
and that good faith efforts have been made to develop a substitute. So
that existing PCBs may be reused rather than disposed of, the prohibi-
tions do not apply to distributions in commerce of PCBs sold for pur-
poses other than resale before the effective date of the prohibition on
distribution of PCBs.

IMMINENT HAZARDS

Senate hill {section 7)

The Senate bill authorizes the Administrator to initiate a judicial
proceeding against an imminently hazardous chemical substance or
mixture or against any person who manufactures, processes, distributes
in commerce, uses or disposes of such substance or mixture or against
both. The court is authorized to grant such temporary or permanent
relief as is necessary to protect against the hazard. Such re^ef may
include seizure and condemnation of the imminently hazardous sub-
stance or mixture. Further, the court is specifically authorized to
require manufacturers, processors, or distributors to provide notice
of the hazard to purchasers of the substance or mixture and to the
public, and to recall and replace or repurchase the substance or mix-
ture. Under the Senate bill an imminent hazard is considered to exist
when the evidence is sufficient to show that a situation exists in which
the continued use of a substance or mixture would be likely to result
in unreasonable adverse effects on the environment or an unreasonable
hazard to the survival of an endangered species. An unreasonable
adverse effect is defined to mean an unreasonable risk to man or the
environment taking into account the economic, social, and environ-
mental costs and benefits of the use of the substance or mixture.

House amendment {section 7)

The House amendment differs from the Senate bill in three ways.
First, in addition to authorizing action against imminently hazardous
substances and mixtures, the House amendment explicitly authorizes
actions against articles containing such substances or mixtures. Second,
if the Administrator has not acted under section 6(d) of the House
amendment which authorizes immediate administrative action against
an imminent hazard, the Administratar is required to take action
under section 7. Third, the House amendment differs from the Senate
bill in its definition of an imminent hazard. Under the House amend-
ment an imminently hazardous chemical substance or mixture is one
which causes or significantly contributes to an imminent and unrea-
sonable risk of serious or widespread harm to health or the environ-
ment. Such risk shall be considered imminent if it is shown that the

691

manufacture, processing, distribution in commerce, use or disposal
of a substance or mixture is likely to result in an unreasonable risk
of serious or widespread harm to health or the environment before
a final rule under section 6 can protect against the risk.

Conference substitute {section 7)

The conference substitute follows the House language with a clarifi-
cation (contained in the Senate bill) that relief is authorized against
persons who use or dispose of an imminently hazardous substance or
mixture in addition to persons who manufacture, process, or distribute
in commerce such substances or mixtures. If the Administrator has
not used the authority provided in section 6(d)(2)(A)(i) to make a
section 6(a) rule immediately effective in order to protect against an
imminently hazardous substance or mixture, the Administrator must
bring an action under section 7. The conferees have imposed such a
nondiscretionary duty upon the Administrator to insure that protec-
tion is provided against imminently hazardous substances, mixtures,
and articles containing such substances and mixtures.

The conferees wish to note that while the unreasonable risk of injury
must be imminent, the physical manifestations of the injury itself
need not be. Rather, an imminent hazard may be found at any point
in the chain of events which may ultimately result in injury to health
or the environment. The observance of actual injury is not essential
to establish that an imminent hazard exists. The conferees intend that
action under the imminent hazard section be able to occur early enough
to prevent the final injury from materializing. In using the term
"widespread injury" the conferees do not intend that the imminent
hazard authority with respect to widespread harm be limited to in-
stances in which the risk of injury is geographically widespread.
Rather an unreasonable risk of harm affecting a substantial number
of people, even though it is within a rather limited geographic area,
should be deemed adequate to satisfy the requirement of an unreason-
able risk of widespread injury to health. Of course if the risk of in-
jury to health or environment is serious, it need not be widespread.

REPORTING AND RETENTION OF INFORMATION

Senate hill (sections)

Section 8 sets forth requirements for reporting and retention of in-
formation. Under subsection (a) the Administrator shall issue rules
which require each person who manufactures or processes a chemical
substance or mixture to maintain records and to make such reports as
the Administrator may reasonably require. Such rules shall require
manufacturers or processors of chemical substances or mixtures who
produce such substances or mixtures in small quantities solely for
scientific experimentation or analysis for chemical research or analysis
to maintain records and to submit reports only to the extent necessary
for the effective enforcement of the Act. This subsection also contains
an illustrative list of the kinds of information which the Administra-
tor may require from manufacturers or processors of chemical sub-
stances

To determine which substances are new chemical substances for the
purpose of the pre-market notification provisions of section 5, sub-

692

section (b) requires the Administrator to publish an inventory of
existing chemical substances or mixtures which any person report to
be commercially manufactured or processed within the United States
under subsection (a) or under section 5(a). The Administrator shall
publish such list not later than 270 days after the date of enactment.

Subsection (c) requires any person who manufactures, processes,
or distributes chemical substances or mixtures to maintain records of
adverse reactions to health or the environment alleged to have been
caused by any such substance or mixture. These records shall be main-
tained for 5 years from the date the information was reported to such
person, except that reports dealing with adverse reactions of employees
shall be retained for 30 years.

Subsection (d) requires the Administrator to promulgate rules with
respect to the submission of lists of health and safety studies conducted
or initiated by an}- manufacturer, processor, or distributor in commerce
of any chemical substance or mixture. The Administrator may require
the submission of any study appearing on the list.

Subsection (e) requires manufacturers, processors, or distributors in
commerce of a chemical substance or mixture as well as their liability
insurers to inform the Administrator when they receive information
which supports the conclusion that such substance or mixture causes
or contributes to an unreasonable risk of injury to health or the en-
vironment. Such persons are relieved of such requirement when they
have reason to believe that the Administrator has been adequately in-
formed of the risk.
House amendment {section 8)

Subsection (a) of the House amendment is substantially similar to
the Senate bill except that it exempts small manufacturers or proces-
sors from the reporting requirements. The Administrator may, by
rule, require such persons to maintain records and submit reports on
a chemical substance or mixture subject to a rule or a proposed rule
under section 4, 5 (c) , 5 (g) , or 6. In addition, if relief has been granted
in an imminent hazard proceeding under section 7, the Administrator
may, by rule, require a small manufacturer or processor to maintain
records and submit reports. After consultation with the Administra-
tor of the Small Business Administration, the Administrator, shall,
by rule, prescribe standards for determining which manufacturers and
processors will be considered "small" manufacturers and processors.

As a further limitation, section 8(a) (1) (B) specifies that the Ad-
ministrator may not require the maintenance of records or the sub-
mission of reports with respect to changes in the proportions of the
components of a mixture, unless the Administrator finds that such
recordkeeping or reporting is necessary for the effective enforcement
of the Act.

With respect to the inventory of existing chemical substances re-
quired by subsection (b), the House amendment provides that the
inventory shall include at least each chemical substance which any
person reports under section 5 or under section 8(a) was commercially
manufactured or processed in the United States within 3 years before
the effective date of the rules promulgated under section 8(a). The
House amendment requires the publication of such inventory within
1 year after the effective date of the Act.

693

Subsection (c) differs from the Senate bill in that it allows the
Administrator to determine, by rule, the requirements respecting the
maintenance of records of adverse reactions to health or the environ-
ment alleged to have been caused by a substance or mixture. The Ad-
ministrator may require that records relating to adverse reactions to
employee health be retained for up to 50 years.

Subsection (d) concerning submission of lists of health and safety
studies is similar to the Senate bill.

Subsection (e) of the House amendment does not require liability
insurers to report to the Administrator information which supports
the conclusion that a substance or mixture may cause or significantly
contribute to an unreasonable risk of injury. Manufacturers, proces-
sors, and distributors must report information relating to a substan-
tial risk to health or the environment unless they have actual knowl-
edge that the Administrator has been adequately informed of such
risk.

Subsection (f) of the House amendment provides definitions of
"manufacture" and "process" for the purposes of section 8.

Conference suhstitute {section 8)

The conference substitute follows with some modification the House
amendment of section 8 which outlines the policies and procedures for
reporting and retention of information. Subsection (a) identifies which
persons must, pursuant to rules promulgated by the Administrator,
maintain records and make reports. The conference substitute provides
an illustrative list of the kinds of activities for which recordkeeping
and reporting may be required. The list includes such information as
the identity of the chemical, categories of use, amounts manufactured
or processed, by products, existing data, employees exposed, and the
manner or method of disposal. The information specified may be
required by the Administrator "insofar as known to the person making
the report or insofar as reasonably ascertainable". The conferees in-
tend that the "reasonably ascertainable" standard be an objective,
rather than a subjective one. Thus, the manufacturer or processor
must provide information of which a reasonable person similarly sit-
uated might be expected to have knowledge.

The conference substitute retains the exemptions in the House
amendment relating to reporting by small businesses. The intent of
the conferees is to protect small manufacturers and processors from
unreasonabty burdensome reporting requirements. However, the con-
ferees do not intend to deny the Administrator access to information
which may be necessary either to determine whether a rule or order
should be promulgated or to enforce a final rule or order. Therefore,
the conferees have specifically authorized the Administrator to obtain
reports from small manufacturers and processors of a chemical sub-
stance or mixture with respect to which a rule has been proposed or
promulgated under section 4, 5(b) (4), or 6, or with respect to which
an order or rule is in effect under section 5(e) or 5(f). Thus, once a
rule has been proposed, the Administrator may, by rule, issued m ac-
cordance with the informal rulemaking procedures of section 55a of
title 5, United States Code, require reporting from small manufac-
turers and processors. Under such procedures, the Administrator will

694

be able to obtain timely access to needed information. Similarly, re-
porting may be obtained from small manufacturers and processors of
a substance or mixture with respect to which relief has been granted
in a civil action under section 5 or 7.

The conference substitute adopts, with some clarification, the House
amendment in subsection (b) which requires the Administrator to
compile, keep current, and publish an inventory of chemical substances
and mixtures manufactured or processed in the United States. The
conference committee compromised on the date that the Administrator'
shall first publish the inventory, which publication shall take place
315 days after the effective date of the Act.

The conference substitute accepts the substance of the Senate bill in
subsection (c), which states that records of significant adverse reac-
tions (as defined by the Administrator by rule) shall be retained for
five years after such reactions are reported. Under this provision an
officer or employee designated by the Administrator may inspect the
records maintained on adverse reactions. The conferees intend that
persons under contract with the Administrator be considered em-
ployees of the Administrator. Such contractors and their employees
may have access to records for purposes of this section and through-
out the Act. The conferees recognize the special dangers presented to
persons who are exposed to substances on a daily basis; therefore,
records of adverse occupational effects must be retained for thirty
years.

The seriousness, duration, and the frequency of reactions should be
taken into account in establishing what constitutes a significant ad-
verse reaction. For example, if an individual reports that a chemical
substance causes his or her eyes to become inflamed and to tear, such
reaction may be attributed to an isolated allergic reaction. However, if
several persons report a similar reaction, then the reaction may in-
deed be significant. Because the ultimate significance of adverse re-
actions is difficult to predict, the conferees intend that the require-
ment to retain records err on the side of safety. Some very serious
neurological disorders, for instance, at first present what appear to be
trifling symptons.

The conference substitute includes the Senate version of subsec-
tion (d) concerning health and safety studies with slight modifica-
tions. As Avith the provision concerning adverse reactions, the conferees
emphasize the importance of gaining information which errs on the
side of too much rather than too little. Of course, the Administrator
is to avoid imposing unnecessary or overly burdensome reporting re-
quirements. In cases where test results are submitted, supporting data
and the sources for such data must be included.

The conference substitute follows the House amendment for sub-
section (e) which provides that any manufacturer, processor, or
distributor of a chemical substance or mixture who obtains informa-
tion supporting the conclusion that such substance or mixture presents
a substantial risk of injury to health or the environment shall notify
the Administrator, unless such person has actual knowledge that the
Administrator already possesses the information.

695

RELATIONSHIP TO OTHER FEDERAL LAWS

Senate hill {section 9)

Section 9(a) of the Senate bill provides that if the Administrator
(A) has reason to believe that the manufacture, processing, distribu-
tion in commerce, use, or disposal of a chemical substance or mixture
causes or contributes to, or is likely to cause or contribute to. an unrea-
sonable risk of injury to health or the environment, and (B) deter-
mines, in the Administrator's discretion, that such risk may be
prevented or reduced to a sufficient extent by action taken under a
Federal law not administered by EPA, then the Administrator must
request the agency which administers such law to issue an order. Such
agency shall consider all data submitted by the Administrator and
issue an order declaring whether or not the manufacture, processing,
distribution in commerce, use, or disposal of such substance or mix-
ture causes or contributes to or is likely to cause or contribute to
such a risk. If such agencv makes such determination it shall also de-
termine if such risk may be prevented or reduced to a sufficient extent
by action taken under the law (or laws) administered by the agency.

The Administrator may specify the time within which the other
agency must issue the order, but such time may not be less than 90
days from the date the request was made. The other agency must issue
a report including a detailed statement of its findings and conclu-
sions in response to the Administrator's request.

The Administrator shall not take any action under section 6 or 7
of this Act if such other agency (A) issues an order declaring that
there is no unreasonable risk of injury, or (B) initiates action imder
the law (or laws) administered by such agency within 90 days of pub-
lication in the Federal Register of its report in response to the EPA
request.

Section 9(a) of the Senate bill also states that nothing in this sec-
tion shall prevent the Administrator from making any subsequent
request or taking subsequent action under the Toxic Substances Con-
trol Act with respect to such risks if the requirements of section 9(a)
are satisfied.

Section 9(a) of the Senate bill provides that if the Administrator
has initiated action imder section 6 or 7 of this bill with respect to a
risk of injury which is the subject of a request to another agency, such
other agency must consult with the Administrator to avoid duplica-
tion of Federal action against such risk before taking action under the
law or laws it administers.

Section 9(b) of the Senate bill directs the Administrator to coordi-
nate actions taken under this bill with actions taken under other Fed-
eral laws administered wholly or partially by the Administrator. The
Administrator must use the authorities contained in such other Fed-
eral laws to protect against any risk to health or the environment asso-
ciated with a chemical substance or mixture unless the Administrator,
in the Administrator's discretion, determines that such risk might be
more appropriatelv protected against under this Act. Section 9(b)
does not relieve the Administrator of any duties or responsibilities
imposed bv other Federal law. Nor does section 9(b) affect any final
action taken under such other Federal law or the extent to which

696

human health or the environment is protected under such other law.

Section 9(c) of the Senate bill states that, in exercising any au-
thority under this bill, the Administrator shall not, for purposes of
section 4(b) (1) of the Occupational Safety and Health Act of 1970,
be deemed to be exercising statutory authority to prescribe or enforce
standards or regulations affecting occupational safety and health.

Section 9(d) of the Senate bill requires the Administrator to consult
and coordinate with the Secretary of Health, Education, and Wel-
fare and the heads of other appropriate Federal agencies, departments
or instrumentalities for the purpose of achieving the maximum en-
forcement of this legislation while imposing the least burdens of
duplicative requirements on those subject to the bill, and for other
purposes. The Administrator shall report annually to the Congress
on actions taken to so coordinate authority under this bill with the
authority granted under other EPA-administered laws and laws
administered by other Federal agencies.

Section 9(e) of the Senate bill provides that nothing in section 9
limits any requirement of section 4, 5 (other than section 5(e) (2) ), or
8, or rules promulgated thereunder.

House amendment {section 9)

Section 9(a) of the House bill is similar to section 9(a) of the Sen-
ate bill; however, there are certain differences. First, the Adminis-
trator's determination that an unreasonable risk to health or the
environment may be prevented or reduced to a sufficient extent by
action taken under a Federal law not administered by the Adminis-
trator is not discretionary. Second, if such a determination is made, the
Administrator shall submit a report to the agency administering such
other law. Such report shall describe such risk and include a specifica-
tion of the activity or activities which the Administrator has reason
to believe caused or contributed to such risk.

Such report shall request such agency to determine whether the risk
might be prevented or reduced to a sufficient extent by action taken
under such law. Conditioned upon such a determination shall be a
request that the agency issue an order declaring whether the activity
or activities specified in the Administrator's description caused or sig-
nificantly contributed to such risk, which determination and order
shall be reported to the Administrator.

Like the Senate bill, section 9(b) of the House bill requires the
Administrator to coordinate actions taken under this legislation with
actions taken under other laws administered in whole or in part by
the Administrator; however, the language of the House bill differs
regarding the Administrator's authority to regulate a risk to health
or the environment associated with a chemical substance or mixture.
Unless the Administrator determines that it is in the public interest
to protect against such risk by actions taken under this Act, the House
amendment requires the Administrator to use the authorities contained
in other laws, if such risk could be eliminated or reduced to a sufficient
extent.

Sections 9(c) and (d) of the House amendment are identical to the
Senate bill. The House amendment contains no provision similar to
section 9(e) of the Senate bill.

697

§4

Conference substitute {section 9)

The conferees have drawn from both the Senate bill and the
House amendment to assure that overlapping or duplicative regula-
tion is avoided while attempting to provide for the greatest possible
measure of protection to health and the environment.

Section 9(a) establishes the relationship between the Act and Fed-
eral laws not administered by the Administrator. If the Administrator
has a reasonable basis to conclude that the manufacture, processing,
distribution in commerce, use, or disposal of a chemical subtance or
mixture presents or will present an unreasonable risk of injury and if
the Administrator makes a discretionary determination (which is not
subject to judicial review) that the risk may be prevented or reduced
to a sufficient extent by action taken under a Federal law not admin-
istered by the Administrator, then the Administrator must give the
other agency an opportmiity to act to protect against the risk before
the Administrator uses the authorities in section 6 or 7 to protect
against the risk.

If the Administrator determines that another Federal law con-
tains authorities adequate to j)revent or reduce the suspected risk
to a sufficient extent, the Administrator shall submit to the agency
which administers the law a report which describes the risk, includ-
ing a specification of the activity or combination of activities associ-
ated with the substance or mixture which the Administrator believes
presents the risk. The report must also include a detailed statement
of the information on which it is based. The report shall also request
the agency to determine if the risk described in the report may be
prevented or sufficiently reduced by action taken under its law and,
if such determination is affirmative, to issue an order declaring wheth-
er or not the activity specified in the report presents an unreasonable
risk.

The agency receiving the request from the Administrator must re-
spond to the Administrator within such time as the Administrator
specifies. However, the Administrator must give the other agency at
least 90 days.

Section 9(a) prohibits the Administrator from acting under sec-
tion 6 or 7 with respect to the risk about which the Administrator
notified the other agency if the other agency takes one of two alterna-
tive courses of action. First, if the other agency issues an order declar-
ing that the activity specified in the Administrator's report does not
present the unreasonable risk described in the report, then the Admin-
istrator may not take action under section 6 or 7 with respect to such
risk. Alternatively, if within 90 days of the publication in the Federal
Register of the other agency's response, the other agency initiates
action to protect against such risk, then the Administrator is precluded
from taking action under section 6 or 7 with respect to such risk. If
the other agency does not take one of these actions, then the Adminis-
trator is permitted to act under section 6 or 7 to protect against the
risk.

The conferees recognize that the other agency may not because of
time constraints be able to initiate formal regulatory action to protect
against the xisk within the specified time period. As long as the other
agency has officially initiated an action which will culminate as soon as

79-313 O - 77 - 45

698

practicable in effective re^latory action to protect against the unrea-
sonable risk and sets forth a general time schedule of steps for such
action, the requirement should be deemed satisfied. However, the re-
quirement that the other agency initiate action to protect against the
risk is not satisfied by the mere open-ended possibility of action by the
other agency.

Subsection (b) establishes the relationship between this Act and
other laws administered in whole or in part by the Administrator.
Subsection (b) requires the Administrator to coordinate actions taken
under this Act with actions taken under other Federal laws adminis-
tered by the Administrator.

If the Administrator determines that a risk to health or the envi-
ronment associated with a substance or mixture could be eliminated or
reduced to a sufficient extent by actions taken under the authorities
contained in other Federal laws, then the Administrator shall use such
other authorities unless the Administrator determines, in the Admin-
istrator's discretion, that it is in the public interevSt to protect against
such risk under this Act. While it is clear that the Administrator's de-
termination that it is in the public interest to use this Act, is a com-
pletely discretionary decision not subject to judicial review in any
manner, it is expected that the Administrator will review the other
authorities and present the results of that review at the same time the
Administrator takes action under this Act. While the Administrator's
decision to use this Act, notwithstanding the other authorities, is un-
reviewable by any court, a reviewing court is expected to require that
the Administrator have examined the other authorities and present
the results of that examination when making the finding that it is in
the public interest to use this Act. Of course, the requirement to ex-
amine other EPA laws and to make determinations applies only when
the Administrator takes regulatory action to protect against an un-
reasonable risk under this Act. It does not apply when the Adminis-
trator takes action necessary for the administration or enforcement of
the Act, such as issuing recordkeeping requirements.

This provision is not to be construed to relieve the Administrator
of any requirement imposed by other Federal laws upon the Adminis-
trator, and of course nothing in this Act shall affect any final action
taken under other Federal laws administered by the Administrator
or in any way affect the extent to which health or the environment
is to be protected under such other Federal laws.

SECTION" 10. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION AND

UTILIZATION OF DATA

Senate hill {section 10)

Section 10 authorizes the Administrator to conduct research and
monitoring in cooperation with the Secretary of Health, Education,
and Welfare and the heads of other appropriate agencies, as is neces-
sary to carry out the purposes of the Act.

The Administrator shall imdertake and support programs of re-
search and monitoring of polychlorinated biphenyls to develop safe
methods of disposal. The Administrator shall also establish, adminis-
ter, and assume responsibility for the activities of an interagency

699

committee to construct within the EPA an efficient system for the col-
lection, dissemination, and use of data submitted to the Administrator
under this Act among other Federal agencies. This interagency com-
mittee shall also direct its attention to coordinating the regulation of
chemical substances among the federal agencies. The Administrator
shall design, establish, and coordinate an effective system for the re-
trieval of toxicological and other scientific data which could be use-
ful to the Administrator in carrying out this Act. This section also
authorizes the Administrator to make grants and to enter into con-
tracts in order to carry out his responsibilities under this section.

House arweivdrrvent {section 10)

The House version of section 10 is substantially similar to the Sen-
ate bill. However, the House amendment omits the requirement that
the Administrator undertake and support programs of research and
monitoring of poly chlorinated biphenyls. The House amendment con-
tains additional specific provisions for various research programs such
as the development of rapid, reliable and economical screening and
monitoring techniques for carcinogenic, mutagenic, teratogenic, and
ecological effects of chemical substances and mixtures.

Conference substitute {section 10)

The conference substitute includes provisions found in both the
Senate bill and the House amendment, but generally follows the
language from the House version. Subsection (a) requires the Admin-
istrator to conduct such research, development, and monitoring as is
necessary to carry out the purposes of this Act. In doing so, the
Administrator must consult and cooperate with the Secretary of
Health, Education, and Welfare and with heads of other appropriate
departments and agencies. The Administrator may enter into con-
tracts and make grants for the purpose of research and development
in this area.

Subsection (b) authorizes the establishment of an interagency com-
mittee whose primary responsibility shall be to design an efficient sys-
tem within the Environmental Protection Agency for the collection
of data (submitted to the Administrator under this Act), the dissemi-
nation of such data to other instrumentalities of the Feneral Govern-
ment, and the use of such data.

Subsection (b) specifies that an efficient and effective data retrieval
system shall be developed. The conferees emphasize that sufficient data
is necessary for successful implementation of this Act, yet they also
acknowledge the burden placed on industry by excessive or duplicative
reporting. It is essential that toxicological and other relevant scientific
data already in the possession of the Federal Government be made
available to the Administrator. The efficient exchange of information
among Federal agencies and departments will facilitate implementa-
tionof this Act, and every effort should be made to achieve this goal
and to avoid duplicative requirements in information-gathering.

Subsections (c), (d), (e), (f),and (g) of the conference substitute
adopt provisions from the House amendment which concern research
and development in the area of data collection. The conferees do not
intend that Such projects should detract from the primary purposes
of the Act, but rather that those purposes should be enhanced by

700

allowing the development of proper tools. Thus the purpose of these
subsections is to provide the means to an end. They should in no case
detract from the main purposes of the Act nor from other equally
important research conducted by the Administrator, but should con-
tribute to the achievement of those purposes where appropriate. Of
course, such research and development should not duplicate any re-
search and development already being conducted by other Federal
agencies and departments. Thus, careful coordination and consultation
with such departments and agencies is required.

INSPECTIONS AND SUBPOENAS

Senate hill {section 11)

The Senate bill authorizes the Administrator or any duly designated
representative to inspect any establishment, facility or other premises
in which chemical substances or mixtures are manufactured, processed,
stored or held before or after distribution in commerce. Inspections are
also authorized of conveyances used to transport chemical substances
or mixtures in connection with distribution in commerce. Inspections
may extend to all things within the premises or conveyances inspected
bearing on whether the requirements of the Act have been complied
with.

The Senate bill also authorizes the Administrator to issue subpoenas
to require the attendance and testimony of witnesses and the produc-
tion of reports, papers, documents, and answers to questions or other in
formation necessary for the Administrator carry out his or her duties
under the Act.

Home ainendment {section 11)

The House amendment contains a similar provision authorizing in-
spections for the purpose of enforcement of the Act. However, the
House amendment provides that no inspection shall extend to financial
data, sales data other than shipment data, pricing data, personnel data,
or research data (other than research data required by the Act) unless
the nature and extent of the data are described with reasonable spec-
ificity in the written notice presented to the owner, operator or agent
in charge of the premises or conveyance to be inspected. The House
amendment contained no subpoena authority.

Conference substitute {section 11)

The conference substitute includes the provision from the Senate bill
with the addition of the House provision relating to inspections of fi-
nancial data, sales data other than shipment data, pricing data, per-
sonnel data or research data (other than research data required by the
Act or pursuant to any rule issued under the Act).

The conferees recognize that the Administrator will have access to
much information under section 5 and section 8 of the Act. Therefore,
the conferees expect that the Administrator will use the subpoena
authority only when information otherwise available through volun-
tary means or under other provisions of this Act is inadequate to meet
the Administrator's needs under this Act.

It should be noted that the conferees intend that representatives of
the Administrator authorized to make inspections should have the

701

opportunity to record the results of such inspections because such
records might be required at some later date ; therefore, it is intended
that persons making the inspection shall be allowed, for example, to
photocopy records or photograph premises.

EXPORTS

Senate hUl {section 12)

This section outlines the policy for chemical substances and mixtures
manufactured, processed, sold, or held for sale solely for export from
the United States. Subsection (a) provides that unless the Adminis-
trator finds that such substances or mixtures will cause or contribute
to an unreasonable risk to the health of persons within the United
States or the environment of the United States, such substances are
exempt from the Act (other than the reporting requirements of sec-
tion 8) if proper labeling shows that they are intended for export use
only.

However, subsection (b) allows the Administrator to require testing
under section 4 to see if such substance or mixture may cause or con-
tribute to a risk of health within the United States or to the environ-
ment of the United States. Subsection (b) also requires that any person
engaged in export activities shall notify the Administrator if such
acti\dties involve chemical substances or mixtures for which data is
required under section 4 or 5 or for which a rule has been proposed
or promulgated under section 5 or 6 or for which action is pending
or relief has been granted under section 7. Should any such circum-
stance arise, the Administrator shall furnish the appropriate foreign
government with relevant information pertaining to the chemical
substance subject to the limitations of section 14.

Home amendment {section 12)

Except for minor differences in language, the House amendment fol-
lows the Senate provision. The House provision also specifically covers
articles containing chemical substances.

Conference substitute {section 12)

The conference substitute follows the policy set forth in both the
Senate and House provisions to protect the health and environment of
persons in the United States and to provide information to foreign
governments regarding chemical substances and mixtures, so that such
foreign governments can protect their own citizens.

ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES

Senate hUl {section IS)

The Senate bill instructs the Secretary of the Treasury to refuse
entry into the United States of any chemical substance or mixture
offered for entry if it fails to conform, with any requirement ot the
Act or any rule in effect under the Act or if it is otherwise prohibited
from being distributed in commerce. If a substance or mixture is
refused ent^^ the Secretary of the Treasury is required to notify the
consignee of'^the entry refusal. If the substance or mixture is not
exported within 90 days, the Secretary is to cause the disposal or
storage of the substance or mixture.

702

House amendment {section 13)

The House amendment contains a similar provision.
Conference substitute {section 13)

The conference substitute adopts the provision found in both the
Senate bill and the House amendment relating to entry into the
customs territory of the United States. Although the Secretary of
the Treasury is authorized to cause the disposal of substances and
mixtures which have been refused entry, and are not exported within
90 days, the conferees intend that the Secret-ary consult with the
Administrator before determining the disposal methods for the sub-
stance or mixture.

DISCLOSURE OF DATA

Senate hill {section H)

The Senate bill provides generally that all information obtained
by the Administrator under this Act shall be subject to the Freedom
of Information Act (5 U.S.C. 552). The Freedom of Information Act
makes such information available to the public upon request, unless
the information requested falls into one of nine exceptions.

The Senate bill also requires the disclosure of data in certain fur-
ther specified situations. If officers or employees of the United States
request information in connection with their official duties under laws
protecting human health or the environment or for specific law en-
forcement purposes, then the Administrator must disclose the infor-
mation to them.

Likewise, the Administrator must disclose information to the pub-
lic whenever the Administrator determines it is necessary to protect
human health or the environment. If the Administrator determines
that disclosure of information is necessary for a contractor or the
contractor's employee to perform official duties satisfactorily under
contracts for the United States in connection with this Act, then the
Administrator must disclose the information. Finally, the Administra-
tor must disclose information to any duly authorized committee of
Congress upon written request.

House amendment {section H)

The House amendment contains some similarities to, but also some
differences from, the Senate bill. Whereas the Senate bill states that
the Freedom of Information Act applies except in certain areas where
disclosure is mandatory, the House bill statutorily prohibits the dis-
closure of information which falls into one of the exemption cate-
gories (subsection (b) (4) (5 U.S.C. 552(b) (4))) of the Freedom of
Information Act.

Subsection (b) (4) of that Act encompasses matters that are trade
secrets and commercial or financial information obtained from a per-
son and privileged or confidential. The Administrator may not disclose
information under that classification except to officers or employees
of the United States in connection with their duties to protect health
or the environment or for specified law enforcement purposes or
to contractors with the United States or their employees in con-
nection with this Act. Such information may be disclosed when
relevant to a proceeding under this Act, but the disclosure must pre-

703

serve confidentiality as much as possible without impairing the
proceeding.

Subsection (b)(1) specifically provides that disclosure of any
health and safety study for any chemical substance or mixture which
is already being distributed or for which testing is required under
section 4 or for which notification is required under section 5, is not
prohibited. Data in such a study which discloses a manufacturing
process or the proportions of a mixture may not be disclosed if such
process or proportions would otherwise be entitled to protection from
disclosure.

Subsection (c) authorizes any person Avho submits data under the
bill to designate information he believes is entitled to confidential treat-
ment under section (a). Designated information may not be released
for 30 days after notification of release has been received by the person
submitting such data.

Conference substitute {section H)

The conference substitute adopts elements of both the Senate bill
and the House amendment. The prohibition against disclosure of in-
formation exempt from mandatory disclosure under section (a) of
section 552 of title 5, United States Code, by reason of its falling
within the exemption under subsection (b) (4) of such section, is
included. Section 14 applies to any release of information obtained
under the Act.

Mandatory exceptions from this prohibition are also provided. Dis-
closure of information described in section 552(b)(4) of title 5 is
required in the following situations :

( 1 ) To officers or employees of the United States in connection
with their official duties to protect health or the environment, and
for specific law enforcement purposes.

(2) To contractors with the United States when the Adminis-
trator determines it to be necessary for the satisfactory perform-
ance of their duties in connection with this Act and under such
conditions as necessary to preserve confidentiality as the Admin-
istrator may specify.

(3) If the Admmistrator determines it necessary to protect
health or the environment against an unreasonable risk of injury
to health or the environment.

In addition, the Administrator may disclose such information when
relevant under a proceeding under this Act, except that disclosure
under such proceeding shall be made in such a manner as to preserve
confidentiality to the extent practicable without impairing the hearing.
It is intended that the Administrator exercise due care to prevent the
release of confidential information to competitors of persons submit-
ting data merely because the competitors have joined the proceeding.

In any proceeding under section 552(a) of title 5 to obtain informa-
tion which the Administrator has refused to release on the basis that
disclosure is prohibited by section 14(a) of this Act, the Administrator
mav not rely on section 552(b) (3) of title 5 to sustain the refusal to
disclose the information. Thus the Administrator will have to show
that the information falls within section 552(b)(4) of title 5. Of
course, section 552 of title 5 is the vehicle through which the public can
obtain information from the Federal government, and all the provi-

704

sions of that section will apply to requests for information obtained
under this Act.

The conference substitute specifically provides that disclosure of any
health and safety study or information from such a study on any sub-
stance or mixture which is already being distributed or for which test-
ing is required under section 4 or for which notification is required
under section 5, is not prohibited. Data in such a study which dis-
closes manufacturing processes or the proportions of a mixture may
not be disclosed if such processes or proportions would otherwise be
entitled to protection from disclosure. However, any restriction on the
release of such data will not apply to the health and safety study in
which it is contained or from which it is derived. To comply with such
restriction the Administrator need only to exclude such data when
releasing such study.

If a request is made to the Administrator for health and safety study
information which is not entitled to protection, the Administrator may
not deny a request under section 552 of title 5, United States Code, on
the basis that such information is included in the exceptions to manda-
tory disclosure enumerated in subsection (b) (3) or (b) (4) of such
section. It is also intended that the Administrator not use exception
(b) (7) of section 552 of title 5, relating to matters under investigation,
in an excessi^ manner as a device for withholding information sub-
mitted under this Act. In order to be withheld under that exception,
the information must be the subject of an ongoing, active investigation.

In submitting data, a person may designate data which the person
believes is entitled to confidential treatment under this Act and submit
it separately. If the Administrator proposes to release for inspection
designated data, the Administrator must give 30 days notice to the
person who submitted the information. Thirty days advance notice
need not be given when information is to be released under one of
the mandatory exceptions described above or when disclosure is not
prohibited because the information is health and safety data. When
disclosure is proposed because it is necessary to protect health and
the environment from an unreasonable risk, the Administrator shall
provide the person submitting the data written notice by certified
mail of the proposed release at least 15 days prior to the release.
The purpose of this provision is to provide the person submitting
the data an opportunity to seek to stop the proposed release if that
person disputes the Administrator's determination. The conferees
recognize that there may arise emergency situations in which the
Administrator determines that earlier release is necessary. In such
cases, where the occurrence of the unreasonable risk is imminent, the
Administrator need give notice only 24 hours prior to release. The
required notice need not be given in writing but may be made by some
other means such as telephone or telegraph.

The criminal penalties for wrongful disclosure contained in the
House bill have been included in the conference substitute.

PROHIBITED ACTS

Senate hill {section 15)

The Senate bill makes it unlawful for any person to fail or
refuse to comply with any rule or order promulgated under section

705

4, 5, or 6, or any requirement prescribed by section 5 or 6. It also
makes it unlawful for any person to use or dispose of a chemical sub-
stance or mixture which the person knew or had reason to know was
manufactured, processed or distributed in commerce in violation of
section 5 or a rule or order under section 6, Failure or refusal to es-
tablish or maintain records, submit reports, notices, or other informa-
tion or to permit access to, or copying of, records is also unlawful.
Finally, the Senate amendment makes unlawful the failure or refusal
to permit entry or inspection as required by section 11.

House amendment {section 15)

The House amendment makes it unlawful for any person to fail or
refuse to comply with any rule or order promulgated under section 4,
5 or 6 or any requirement prescribed by section 5. It also makes it un-
lawful for any person to use for commercial purposes a chemical sub-
stance or mixture which the person using such substance or mixture
knew or had reason to know was manufactured, processed or distrib-
uted in commerce in violation of section 5, a rule or order under section
5 or 6 or an order issued in an action brought under section 5 or 7. The
House provisions respecting maintenance of records, submission of
reports, entry, and inspections are identical to the Senate bill.

Conference substitute {section 15)

The conference substitute incorporates the provisions of the House
bill with a conforming amendment making violations of the provisions
of section 6 relating to poly chlorinated biphenyls an unlawful act.

PENALTIES

Senate hill {section 16)

This section outlines the penalties and procedures for assessing pen-
alties against persons who violate section 15. Subsection (a) provides
for civil penalties of up to $25,000 per day per violation. Taking rele-
vant factors into account, the Administrator shall assess the amount
of such civil penalties in an order made on the record after the op-
portunity for an adjudicative hearing and proper notification of the
person in violation of this Act. Such person may file a petition for
judicial review of an order assessing civil penalties in U.S. Court of
Appeals within thirty days ; however, if a person fails to pay such as-
sessment after it has become a final and unappealable order or after
the Court of Appeals has found in favor of the Administrator, then
the Attorney General shall recover the amount assessed.

Subsection (b) provides for criminal penalties of up to $25,000
per day or up to one year's imprisonment, or both, per violation for
any person who knowingly or willfully violates this Act.
House amendment {section 16)

The House amendment follows subsections (a) and (b) of the Sen-
ate provision. In addition, subsection (c) of the House Amendment
provides that the Administrator may require a person who has man-
ufactured, processed, or distributed a chemical substance or fixture
in violation of regulations issued under paragraphs (1) oi (2) ot
section 6 (a) to give notice of the risk associated with that substance
to any person who may be exposed to it and to the public at large.

706

The Administrator may also require such person to either replace or
repurchase the substance found to be in violation. The Administrator
may choose any or all of the remedies set forth in subsection (c) ; how-
ever, in each case the order must be made on the record with full op-
portunity for an agency hearing.

Conference substitute {section 16)

The conference substitute adopts the provisions found in both bills
concerning civil and criminal penalties for violations of this Act.
Under subsection (a), the Administrator shall assess the amount of
civil penalties up to $25,000 per day per violation; however, the
Administrator must take into account such factors as the gravity and
extent of the violation, the ability to pay of the person held in viola-
tion, and any prior history of violations under this Act.

Criminal penalties may be imposed on persons who "knowingly or
willfully" violate any provision of section 15, which sets forth unlawful
acts.

SPECIFIC ENFORCEMENT AND SEIZURE

Senate hUl {section 17)

The Senate bill grants the United States district courts jurisdiction,
upon application of the Administrator or the Attorney General, to
restrain any violation of section 15, to restrain any person from man-
ufacturing or processing a chemical substance before the expiration
of the notification period under section 5, and to restrain any person
from taking any action prohibited by a requirement prescribed under
section 5 or 6 or rules or orders issued under section 5 or 6. In addi-
tion, the courts are granted jurisdiction to direct any manufacturer or
processor of a chemical substance or mixture who is not in compliance
with any order issued under section 5(e) or any rule issued under sec-
tion 4 or 6 to give notice of such fact to persons within the chain of
distribution and to the public, and to either replace or repurchase the
substance or mixture. The Senate provision also authorizes the district
bution and to the public, and to either replace or repurchase the sub-
stance or mixture. The Senate provision also authorizes the district
courts to compel the taking of any action required by or under the
Act. In addition, the Senate bill provides that any substance or mix-
ture manufactured or processed or distributed in commerce in viola-
tion of the Act or any rule or order promulgated under the Act shall
be liable to be proceeded against for seizure and condemnation.

House amendment {section 17)

The House amendment grants jurisdiction to the district courts to
restrain any violation of section 15, to restrain any person from manu-
facturing or processing a substance before the expiration of the notifi-
cation period under section 5, and to restrain any person from taking
action prohibited by section 5 or a rule or order under section 5 or 6.
Jurisdiction is also granted to compel the taking of any action re-
quired by or under this Act. The seizure authority in the House amend-
ment is similar to that found in the Senate bill, except that seizure
and condemnation of articles containing chemical substances or mix-
tures manufactured, processed or distributed in commerce in violation
of the Act or any rule or order promulgated under the Act is specifi-
cally authorized.

707

Conference substitute

The conference substitute grants the district courts of the United
States jurisdiction to restrain any violation of section 15, to restrain
any person from manufacturing or processing a substance before the
expiration of the notification period under section 5, and to restrain
any person from taking any action prohibited by section 5 or 6 or a
rule or order under section 5 or 6. The provision also grants such
courts jurisdiction over actions to direct any manufacturer or proc-
essor of a chemical substance or mixture manufactured or processed
in violation of any order issued under section 5 or any rule or order
issued under section 6 to give notice of the risk associated with the
substance or mixture to persons in the chain of distribution and to the
public. The courts also have jurisdiction to require manufacturers or
processors to either replace or repurchase the substance or mixture,
whichever the person to whom the requirement is directed elects. The
conference substitute also grants jurisdiction to compel the taking of
any action required by or under the Act. The seizure authority in the
conference substitute is identical to that contained in the House
amendment.

PREEMPTION

Senate hill {section 18)

This section outlines the relationship between State authority and
the authority under this Act to regulate chemical substances or mix-
tures. Subsection (a) asserts the State's authority to regulate, with
certain limitations. No State may require testing which duplicates
testing required by the Administrator under a section 4 testing rule.
Further, if the Administrator has prescribed a requirement under sec-
tion 5 or 6 to protect against a particular risk associated with a chemi-
cal substance or mixture, a State may not prescribe any different re-
quirement (other than a total ban) with respect to that risk unless the
State obtains permission from the Administrator to do so.

The Administrator may, by rule, grant such permission if the
Administrator finds that compliance with the State requirement would
not result in a violation of this Act, would result in a significantly
higher degree. of protection, and would not unduly burden interstate
commerce.

House arwendment {section 18)

The House amendment is similar to the Senate bill. However, rules
promulgated under section 6(a) (5) do not preempt State laws. More-
over, rules promulgated under other Federal authorities such as the
Clean Air Act, are not preempted by requirements under this Act.

Like the Senate bill, the House amendment authorizes the Adminis-
trator to exempt, by rule. States from prohibitions under subsection
(a) in the same manner as the Senate bill.
Conference substitute {section 18)

The conference substitute provides that no State or political sub-
division may establish similar requirements for the testing of a sub-
stance or mixture after the Administrator has issued a rule under
section 4 respecting the substance or mixture. Nor may any State reg;u-
late any risk associated with a substance or mixture if the Adminis-
trator has prescribed a rule or order under section 5 or 6, which is

708

designed to protect against the risk to health or the environment,
unless the rule (A) is identical to that issue under this Act, (B) is
adopted under the authority of another Federal law, or (C) prohibits
the use of such substance or mixture other than in its use in the manu-
facture or processing of other chemical substances or mixtures.

In addition to the specific exemptions from the preemption pro-
vision, the conference substitute provides a means whereby a State or
political subdivision may seek an exemption from the preemptive
effects of a Federal requirement in order to provide a higher degree
of protection for their citizens than that provided by a requirement
under this Act. The Administrator may, by rule, grant an exemption
if compliance with the State or local requirement will not cause a
violation of the applicable requirement under this Act, if the State
or local requirement will provide a significantly higher degree of pro-
tection from the risk, and if the State or local requirement will not
unduly burden interstate commerce.

JUDICIAL REVIEW

Senate hill {section 19)

The Senate's provision authorized pre-enforcement judicial review
of any rule under the Act or an order issued under section 5(e). Any
rule promulgated under section 3(b), 5 or 6 shall not be affirmed
unless supported by substantial evidence on the record taken as^-a whole.

House amendment {section 19)

The House provision authorizes pre-enforcement judicial review of
rules issued under section 4, 5 or 6(a). Such rules shall not be
affirmed unless supported by substantial evidence based on the record
taken as a whole.

Conference substitute {section 19)

Section 19 of the conference substitute provides for judicial review
in the courts of appeals of the United States for certain rules promul-
gated under the Act. The jurisdiction for preenforcement review and
review of determinations of the Administrator relating to cross-ex-
amination is exclusively vested in such courts. Not later than 60 days
after the date of promulgation of a rule under section 4(a), 5(a) (2),
5(b)(4), 6(a), 6(e), or 8 any person may file a petition for judicial
review of the rule in the appropriate U.S. court of appeals.

The section specifically defines the rulemaking record to include the
rule being reviewed (which would include the statement of basis and
purpose pursuant to section 553(c) of title 5, United States Code) , any
transcript required to be made of an oral presentation, any written
submission of interested parties, and any other information which the
Administrator considers to be relevant to the rule and with respect
to which the Administrator published a notice in the Federal Register
identifying the information on or before the date of the promulgation
of such rule. In addition certain findings and statements required
to be made with respect to specific rules must also be included in the
rulemaking record. In the case of a rule under section 4(a), the find-
ing required by that section must be included in the record. In the
case of a rule under section 5(b) (4), the finding required to be made

709

by that section must be included in that record. In the case of a rule
under section 6(a), the finding required by section 5(f) or section
6(a), as the case may be, and the statement required by section 6(c)
( 1 ) must be included in the rulemaking record.

The section includes authority for the submission of additional data
and oral or written views and for the modification of the rule being
reviewed.

Generally section 706 of title 5, United States Code, applies to
review of a rule under this section. However, in the case of review of
a rule under section 4(a), 5(b) (4), 6(a) or 6(e), the bill provides
that the courts shall hold unlawful and set aside such rule if the court
finds that the rule is not supported by substantial evidence in the rule-
making record taken as a whole. This provision is in lieu of paragraph
2(E) of section 706 of title 5. It is the intent of the conferees that the
traditional presumption of validity of an agency rule is to remain
in effect. The conferees recognize that in rulemaking proceedings such
as those contained in this bill, which are essentially informal and
which involve both determinable facts and policy judgments derived
therefrom, the traditional standard for review is that of "arbitrary
and capricious". However, the conferees have adopted the "substantial
evidence" test because they intend that the reviewing court focus on
the rulemaking record to see if the Administrator's action is supported
by that record. Of course, the conferees do not intend that the court
substitute its judgment for that of the Administrator.

Further, in the case of review of a rule under section 6(a) , the court
shall set the rule aside if it finds that action by the Administrator in
excluding or limiting cross-examination or rebuttal submissions pre-
cluded disclosure of disputed issues of material fact necessary for a
fair determination of the rulemaking proceeding taken as a whole.
Also, in review of such rules, section 706(2) (D) will not apply with
respect to review of the Administrators actions respecting limitations
or exclusions of cross-examination or rebuttal submissions, and review
of such actions can occur only during preenforcement judicial review.

Section 19 also provides that the court may not review the con-
tents and adequacy of any statement required to be made pursuant to
section 6(c)(1) or any statement of basis and purpose required by
section 553(c) of title 5 of United States Code to be incorporated in
the rule except as part of a review of a rulemaking record taken as a
whole.

Section 19 provides that in a judicial review proceeding under this
section the court may award the costs of suit and reasonable fees for
attorneys and expert witnesses if the court determines that such an
award is appropriate. In addition, in any review of such an action the
Supreme Court may also award such costs of suit and reasonable fees.

The section also provides that the remedies provided in section 19
shall be in addition to, and not in lieu of, any other remedies provided
by law. This provision should not be construed, however, to negate the
provision in this section Avhich specifically provides that the United
States courts of appeals shall have exclusive jurisdiction of any action
to obtain judicial review (other than in an enforcement proceeding)
if any district court of the United States would have had jurisdiction
of such an action but for the provisions of this section.

710

citizen's civil actions

Semite hill {section 20)

Subsection (a) authorizes any person to commence a civil action in
specified district courts against (A) any person including the United
States or any governmental agency or instrumentality alleged to be
in violation of this Act or any rule or order prescribed under sections
4, 5, or 6(a). Such suits may also be brought to compel the Adminis-
trator to perform any nondiscretionary act or duty.

Subsections (b), (c), and (d) specify certain procedural provisions.
No action may begin until the Administrator and the alleged violator
have received proper notice of the alleged violation. If the Administra-
tor has instituted a civil action against an alleged violator to compel
compliance, then no action may be brought under this section. However,
if the Administrator does not commence such action until after the
person bringing the citizen's civil action has notified the alleged vio-
lator of intention to sue under this Act, then the person who gave
such notification may intervene in the suit brought by the Adminis-
trator. The Administrator may intervene in any civil action under
this section to which the Administrator is not a party. The court may
award the costs of the suit and reasonable fees for attorneys and
expert witnesses. The court may also consolidate two or more civil
actions involving the same defendant, the same issues, or the same
alleged violations when appropriate.

Home amendment {section 20)

The House amendment contains the same provision as the Senate
bill.

Conference substitute {section 20)

The conference substitute contains the provision included in both the
Senate bill and the House amendment with a clarification that citizen's
civil actions may also be brought for violations of an order under
section 6 or 6.

citizens' petitions

Senate hill {section 21)

Section 21 of the Senate bill authorizes any person to j)etition the
Administrator to issue a rule or order or to take other action for the
purpose of protecting against an unreasonable risk of injury to health
or the environment. If the petition is denied or not acted upon within
90 days, the petitioner may bring a civil action in a United States
district court to compel the Administrator to initiate the requested
action. If the petitioner demonstrates by a preponderance of the evi-
dence in a de novo proceeding that the action requested in the petition
conforms to the applicable requirements of the Act, the court shall
order the Administrator to initiate the requested action.

House amendment {section 21)

The House amendment authorizes any person to petition the Ad-
ministrator to initiate a proceeding for the issuance, amendment, or
repeal of a rule under section 4, 5 (c) , or 6 (a) . If the petition is denied,
the petitioner may file a civil action to compel the Administrator

711

to initiate the rulemaking proceeding. If the petitioner requests the
issuance of a rule under section 4, 5(c), or 6(a) (as opposed to the
modification or repeal of such a rule) the petitioner has an opportu-
nity for a de novo proceeding before the court. If the petitioner makes
the requisite showings for the applicable provision, the court must
order the Administrator to initiate the requested action unless the
court finds that the failure of the Administrator to initiate the re-
quested action was not unreasonable.

Conference substitute {section 21)

The conference substitute authorizes any person to petition the Ad-
ministrator to initiate a proceeding for the issuance, amendment or
repeal of an action under section 4, 5(e), 6, or 8 of the Act. It should
be noted that a petition under this section may be used to initiate a
proceeding under section 5(f) since a proceeding under that section is
for the issuance of a rule under section 6(a). The Administrator must
grant or deny any petition under this section within 90 days after it is
filed.

The conference substitute thereafter provides for different judicial
review of the Administrator's denial of a petition, depending upon
whether such petition seeks the issuance of a rule or order or the amend-
ment or repeal of an existing rule or order.

The substitute affords greater rights to a person petitioning for the
issuance of a rule or order because in such a situation the Administra-
tor will not previously have addressed the issue by rule or order. If the
Administrator denies or fails to respond to a petition for the issuance
of a rule or order, the petitioner may commence a civil action in a
United States district court to compel the Administrator to take the
action requested in the petition. In the court, the petitioner is entitled
to a de novo proceeding. If the petitioner demonstrates to the court
by a preponderance of the evidence that there is an adequate basis
for the issuance of the rule or order requested, the court shall order
the Administrator to initiate the requested action.

The court may defer requiring the Administrator to take the re-
quested action if it finds that the extent of risk of injury to health or
the environment alleged by the petitioner is less than those risks of
injury which the Administrator is addressing under this Act and there
are insufficient resources to do both. If a deferral is granted, the con-
ferees anticipate that the Administrator may seek extensions as needed.

The conference substitute provides different treatment for review
of petitions for amendment or repeal of rules or orders, because the
Administrator already will have addressed the general subject matter
in an existing rule or order and the Administrator's determination
will have been subject to review under section 19 of this Act. There-
fore, the conferee's main interest is to make certain that any such peti-
tioner receive timelv consideration of such petition. By requirmg the
Administrator to act on anv such petition within 90 days, the conferees
will facilitate such a petitioner's right to seek judicial review should
the Administrator deny the petition. Otherwise, the Administrator
could avoid any judicial review simply by failing to take any action.

The confeffees believe that a petition for amendment or repeal of an
existing rule or order should contain newly discovered, noncumulative

712

material which was not presented for the Administrator's considera-
tion in promulgating the rule or order. Failure to include such infor-
mation would be an adequate basis for denying the petition.

At the same time, the conferees do not intend that the Administra-
tor be subjected to constant petitions challenging rules or orders for
which adequate judicial review is provided under section 19. There-
fore, if the Administrator denies a petition to amend or repeal an
action under section 4, 5(e), 6, or 8, the conference substitute permits
review of such denial only under the Administrative Procedure Act.

NATIONAL DEFENSE WAI\rER

Senate hill {section 22)

The Senate bill directs the Administrator to waive compliance with
finy provision of this Act upon the request of the Secretary of De-
fense and a determination by the President that the interest of na-
tional defense requires such a waiver. The Administrator shall
maintain a written record of the basis for the waiver. In addition, the
Administrator shall publish notice of the waiver in the Federal
Register, unless the Administrator determines, upon request from
the Secretary of Defense, that such publication is contrary to national
defense interests, in which case, the Administrator shall notify the
Armed Services Committees of the Senate and the House of
Representatives.

House amendment {section 22)

The House amendment is similar to the policies and procedures
of the Senate bill except that only the President, not the Secretary of
Defense, is authorized to request a national defense waiver from the
Administrator and to request that publication of the waiver not be
placed in the Federal Register for national defense reasons.

Conference substitute {section 22)

The conference substitute includes the provision of the House
amendment.

EMPLOYEE PROTECTION

Senate hill {section 23)

Section 23 of the Senate bill provides protection for employees who
cooperate with the Administrator in carrying out the Act. The pro-
vision prohibits any employer from discharging any employee or
otherwise discriminating against the employee with respect to com-
pensation, terms, conditions, or privileges of employment because the
employee commenced, caused to be commenced, or is about to commence
a proceeding under the Act. Protection is provided for employees who
have testified or are about to testify in any proceeding under the Act
or who have assisted or participated in a proceeding or any other ac-
tion to carry out the purposes of the Act. The Secretary of Labor shall
conduct investigations of alleged violations and issue orders to require
any person who violates the prohibitions to take affirmative action to
remedy any such violation. Any person adversely affected by an order
of the Secretary may obtain judicial review of the order in the United
States court of appeals for the circuit in which the violation allegedly
occurred. The Secretary is authorized to enforce the orders in the dis-

713

100

trict court of the United States for the district in which the violation
occurred.

House amendment {section 23)

The House amendment contains an identical provision.
Conference substitute {section 23)

The conference substitute adopts the provision found in both the
Senate bill and House amendment.

EMPLOYMENT EFFECTS

Semate hill {section 23 {f) )

The Administrator shall conduct continuing evaluation of the ef-
fect on employment of rules or orders under this Act. Any employee
who is discharged or whose employment is threatened or who is other-
wise discriminated against as a result of any action under this Act
may request investigation of the matter by the Administrator. The
Administrator shall investigate the matter. If any interested party
requests a hearing, the Administrator shall conduct a public hearing
in accordance wdth section 554 of title 5, United States Code, at which
the parties are required to present information on any employment
effects.

Upon receipt of the investigation report, the Administrator shall
make findings of fact as to the employment effects and shall make ap-
propriate recommendations which shall be available to the public.

House amendment {section 2^)

The House amendment is similar to the Senate bill. The House pro-
vision differs from the Senate's primarily as to whether and how a
hearing requested by an interested person shall be conducted.

Upon request, the Administrator must hold a public hearing unless
the Administrator determines that there are no reasonable grounds for
such hearing. The hearing need not be a formal adjudicative hearing
under 5 U.S.C. 554. Provision is made for subpoenas, oaths, and pay-
ment of witness fees in connection with any investigation or public
hearing conducted under this section.

Conference substitute {section 24)

The conference substitute follows the House amendment with two
modifications. First, if the Administrator determines that there are
no reasonable grounds for holding a hearing, the Administrator must
so find, by order, within 45 days of the date within which time such
hearing is requested. Second, if a hearing is held, it shall be in accord-
ance with the requirements of section 6(c) (3) of this Act.

STUDIES

Senate bill {section 24)

The Senate bill requires the General Accounting Office to conduct a
study of all Federal laws administered by the Administrator to deter-
mine whether and under what conditions, if any, idemnification should
be accorded any person as a result of action taken by the Administra-
tor under such' laws. The Senate bill also requires the Council on En-
vironmental Quality to coordinate a study of the feasibility of

79-313 O - 77 - 46

714

101

establishing a standard classification system of chemical substances
and related substances and a standard method for storing and obtain-
ing* rapid access to information respecting such substances.

House amendTiient {section 25)

The House amendment contains a similar provision except that the
indemnification study shall be conducted by the Administrator and
reviewed by the General Accounting Office.

Conference substitute {section 25)
The conference substitute includes the House provision.

ADMINISTRATION OF THE ACT

Senate hill {section 26)

Subsection (a) gives authority to each federal department and
agency to cooperate with the Administrator, upon request, by sharing
services of personnel, facilities, and information in order to carry out
the purposes of this Act.

Subsection (b) provides that the Administrator may, by rule, re-
quire payment from any person submitting data pursuant to section
4 or 5 to help defray administrative costs, provided that no such fee
exceeds $2,500.

Under subsection (c), the Administrator may act with respect to
categories of comical substances or mixtures. For purposes of this
section, a category includes chemical substances or mixtures grouped
by virtue of similarity of chemical structure, physical, chemical, or
biological properties, use or mode of entry into the human body or en-
vironment, or some other suitable grouping.

Under subsection (d) , any proposed or final rule or order under this
Act shall be accompanied by a statement of purpose and justification,
which identifies the basis for the action. This statement shall become
part of the ''record of the proceedings" for purposes of judicial review
under section 19(a).

SubvSection (e) directs the President to appoint by and with the
advice and consent of the Senate, an Assistant Administrator of the
Environmental Pmtection Agency to administer this Act. The Assist-
ant Administrator shall be qualified to direct a program concerning
the effects of chemicals on health and the environment by reason of
background and experience.

House am-endment {section 26)

The House amendment contains provisions similar to the Senate
bill concerning cooperation among federal agencies and fees to be paid
by persons submitting data under section 4 or 5 to defray administra-
tive costs, except that no small businesses shall be required to pay
administrative fees exceeding $100. The House amendment also in-
includes a provision on categories similar to that in the Senate bill.

No provision is made in the House amendment for appointment of
an Assistant Administrator for Toxic Substances. However, the House
amendment establishes an office within the Environmental Protection
Agency to provide technical and other nonfinancial assistance to man-
ufacturers and processors of chemical substances and mixtures
concerning the requirements and application of this Act.

715

102

The House amendment does not contain a specific provision requir
ing that each proposed or final rule or order be accompanied by s
statement of purpose or justification.

The House amendment in section 29 provides that each officer and
employee of the Environmental Protection Agency and the Secretary
of Health, Education, and Welfare who perform any function or duty
under the bill and who has any known financial interest in any person
subject to the bill or in any person who applied for or received any
financial assistance pursuant to the bill must, beginning February 1,
1977, annually file with the appropriate agency or department a
statement concerning all such interests during the preceding calendar
year. Such statement must be available to the public.

The House amendment also directs the Administrator and the Secre-
tary, within 90 days after enactment, to define "known financial inter-
est" and to establish methods to monitor, enforce, and review the filing
of such statements. They are also directed to report each year to Con-
gress on June 1 regarding such disclosures and actions taken concern-
ing them during the preceding calendar year.

Officers or employees in designated positions of a nonregulatory or
nonpolicym.aking nature may be exempted, by rule, from the require-
ments of this section.

The House amendment states that any officer or employer who is
subject to, an^ knowingly violates, this section or any regulations
issued thereunder is to be fined not more than $2,500 or imprisoned
for not more than one year, or both.

Conference substitute {section 26)

The conference substitute incorporates provisions from both the
Senate bill and the House amendment. Subsection (a) gives authority
to each federal agency and department to cooperate with the Admin-
istrator to carry out the purposes of this Act.

The Administrator is authorized to require, by rule, payment of
reasonable fees from any person required to submit data under sections
4 and 5 in order to defray the costs of administering this Act. In no
case shall such fees exceed $2,500, or $100 in the case of a small business.
In all cases when setting such fees, the Administrator shall take into
account the ability to pay of persons submitting data.

The conference substitute includes the House provision concerning
categories in subsection (c). The conferees expect that the Adminis-
trator will find the authority to categorize especially helpful m pro-
mulgating rules under section 5(a)(2) concerning what constitutes
significant new use of chemical substances.

The conference substitute adopts the provision from the House
amendment which establishes an office within EPA to provide technical
and other nonfinancial assistance to manufacturers, processors of
chemicals, and others. The purpose of the office is to help manufac-
turers and processors understand the requirements of the Act in order
to assist in its efficient implementation and to avoid unnecessary con-
fusion, which might prove detrimental to the chemical industry and
the public interest. . . . ,

The conference substitute adopts the House provision on hnancial
disclosures for which the Senate bill had no comparable provision.

716

103

The procedures and penalties are designed to make sure that persons
who perform regulatory functions under this Act divulge any known
financial interest such persons may have in any person subject to this
Act.

Subsection (f) of the conference substitute modifies the require-
ment in the Senate amendment that each proposed or final rule or
order be accompanied by a statement of basis and purpose to apply
only to final orders.

The conference substitute includes the provision found in the Senate
bill that the President appoint, with the advice and consent of the
Senate, an Assistant Administrator for Toxic Substances who shall
direct a program concerning the effects of chemicals on hmnan health
and the environment and perform other duties and responsibilities
under this Act.

While the Assistant Administrator for Toxic Substances will be
assigned responsibilities pursuant to this Act, the Administrator may
assign additional duties. Of course this position will be in addition to
the existing five assistant administrator positions established by
Reorganization Plan No. 3 of 1970.

DEVELOPMENT AND EVALUATION OF TEST METHODS

Senate hill

The Senate bill contains no provision respecting development and
evaluation of test methods.

House amendment {section 27)

The House amendment authorizes the Secretary of Health, Educa-
tion, and Welfare, in consultation with the Administrator and acting
through the Office of the Assistant Secretary for Health, to conduct
projects for the development and evaluation of inexpensive and effi-
cient methods for determining and evaluating the health and environ-
mental effects of chemical substances and mixtures.

Conference substitute {section 27)
The House provision is included.

STATE PROGRAMS

Senate hill {section 25)

Section 25 authorizes the Administrator to assist up to three states
in the establishment of demonstration programs to complement fed-
eral efforts under the Act. Subsection (a) describes the functions of
such programs. Subsection (b) requires the Administrator to submit
annual reports to the Congress on the demonstration programs. Sub-
section (c) authorizes appropriation of funds to assist the states in
funding the demonstration programs. Grants shall not exceed 75
percent of the cost of any demonstration program. Subsection (d)
provides that assistance shall be available to those states which can
establish a priority need for such assistance. The Senate bill author-
izes a maximum appropriation of $2 million for the fiscal year endmg
September 30, 1977, $2 million for the fiscal year ending September 30,
1978, and $2 million for the fiscal year ending September 30, 1979.

717

104

House amendment {^section 28)

The House amendment is similar to the Senate bill, but differs
in that grants are authorized only to assist states in addressing risks
associated with substances and mixtures which the Administrator is
unable to address.

The House amendment does not restrict the number of programs
which the Administrator may approve. The House amendment au-
thorizes an annual appropriation of $1 million for the fiscal years
ending September 30, 1978, September 30, 1979 and September 30,
1980.

Conference substitute {section 28)

The conference substitute generally follows the House amendment
with some modification. The Administrator may make grants to States
to establish programs to prevent or eliminate unreasonable risks asso-
ciated with chemical substances or mixtures against which the Admin-
istrator is not able or not likely to take action under this Act. The con-
ferees agreed to a compromise on the authorization for such programs
of $1.5 million for each of the fiscal years 1977 through 1979.

ATJTHORIZATIOX FOR APPROPRIATIONS

Senate hill {section 27)

Section 27 of the Senate bill authorizes to be appropriated to the
Administrator $11,100,000 for the fiscal year ending June 30, 1976,
$2,600,000 for the period beginning July 1, 1976 and ending Septem-
ber 30, 1976, and $10,100,000 for the fiscal year ending September 30,
1977. This section prohibits using funds for construction of research
laboratories.

Section 27(b) of the Senate bill requires that the Administrator
submit concurrently to the Congress any budget requests, supple-
mental budget estimates, legislative recommendations, prepared testi-
mony for Congressional hearings, or comments on legislation to the
President or to the Office of Management and Budget connected with
this Act.

House amendment {section 30)

The House amendment authorizes to be appropriated $12,625,000
for the fiscal vear ending September 30, 1978, $16,200,000 for the
fiscal year ending September 30, 1979, and $17,350,000 for the fiscal
year ending September 30, 1980. The House amendment contained no
provision relating to simultaneous submissions.
Conference substitute {section 29)

The conference substitute authorizes to be appropriated to carry
out the purposes of this Act as follows : $10,100,000 for the fiscal year
ending September 30, 1977; $12,625,000 for the fiscal year ending
September' 30, 1978; and $16,200,000 for the fiscal year ending Sep-
tember 30, 1979. . ,

The conference substitute contains no provision for simultaneous
submission of materials to Congress and the Office of Management and
Budget.

718

105

ANNUAL REPORT

Senate hill (section 28)

The Senate bill requires the Administrator to submit to both the
President and the Congress a comprehensive annual report. The report
shall include (1) a list of the testing required under section 4 and
an estimate of the costs incurred by the person required to
perform the tests; (2) the number of notices received under sec-
tion 5, the number of notices received under section 5 for chemical
substances subject to a section 4 rule, and a summary of any action
taken during the premarket notification period; (3) a list of rules
issued under section 6; (4) a list, with a brief statement of the issues,
of completed or pending judicial actions under the bill ; (5) a summary
of major problems encountered in administration of the bill; and
(6) such recommendations for additional legislation as the Admin-
istrator deems necessary to carry out the purposes of the bill.

Home amendment (section 31)

The House amendment is almost identical to the Senate bill. The
only difference occurs with respect to the date that the Administrator
must submit the first annual report. The House amendment specifies
that the Administrator shall submit the first annual report on or be-
before January 1, 1979.

Conference substitute (section 30)

The conference substitute generally follows the provision of the
Senate bill. The first submission is due on or before January 1, 1978.

REVIEW

Senate hill

The Senate bill contained no rule review provision.
House amendment (section 32)

Section 32 of the House amendment provides that either House of
Congress may veto a rule issued by the Administrator, the Secretary
of the Treasury, or the Secretary of Health, Education, and Welfare
under this Act, by adopting a resolution of disapproval within 60
days.

Conference suhstitute
The House recedes.

EFFECTIVE DATE

Senate hill

The Senate bill contained no specific provision specifying an effec-
tive date ; therefore, the legislation is to take effect upon enactment.
H ouse amendment (section 33)

The House amendment provides that the legislation shall take effect
October 1, 1977.

Conference suhstitute

The conference substitute establishes the effective date as Jan-
uary 1, 1977, except that section 4(f) shall not become effective for
two years.

719

106

Harley O. Staggers,

J OHN M. Murphy,

W. S. Stuckey,

Bob Eckhardt,

Ralph H. Metcalfe,

W1LLLA.M Broidhead,

James H. Scheuer,

Samuel L. Devine,

James T. Broyhhx,

Matthew J. Rinaldo,
Managers on the Part of the House,

Warren G. Magunson,

Vance Hartke,

Phh,!? a. Hart,

John A. Durkin,

John V. Tunney,

Howard Baker,

T. E. Stevens,
Managers on the Part of the Senate,

SENATE CONSIDERATION OF CONFERENCE REPORT

[Excerpt from the Congressional Record, Sept. 28, 1976, Senate, pp. S16802-S17597]

Toxic Substances Control Act — Conference Report

The Presiding Officer (Mr. Stone). Under the previous order, the
Senate will now proceed to the consideration of the conference report
on S. 3149, which will be stated by title.

The assistant legislative clerk read as follows :

The committee of conference on the disagreeing votes of the two Houses on the
amendment of the House to the bill (S. 3149) to regulate commerce and protect
human health and the environment by requiring testing and necessary use re-
strictions on certain chemical substances, and for other purposes, having met,
after full and free conference, have agreed to recommend and do recommend to
their respective Houses this report, signed by all of the conferees.

The Presiding Officer. Without objection, the Senate will proceed
to the consideration of the conference report.

Mr. Magnuson. Mr. PrevSident, today the Senate will take final ac-
tion on S. 3149. the Toxic Substances Control Act. This legislation is,
in my opinion, the most important environmental legislation to come
before the 94th Congress.

In 1971, the Council on Environmental Quality in a report entitled,
"Toxic Substances," concluded that regulatory mechanisms to control
toxic chemicals were seiiously inadequate. This report was the impetus
for the original legislation on toxic substances that was introduced in
the 92d Congress.

In the 6 years since the introduction of this original legislation, over
16 days of hearings and literally thousands of hours have been spent
refining this legislation. The need for this legislation has been increas-
ingly clear as ever-growing lists of chemical substances such as vinyl
chloride, arsenic, asbestos, mercury, lead, PCB's, PBB's, fluorocarbons,
BC]\IE, sulfuric acid, and many others have been shown to pose poten-
tial dangers to man and the environment.

Dr. David Rail, Director of the National Institute of Environmental
Health Science of the National Institute of Health, stated :

Man is assaulted by these compounds alone and in combination from multiple
sources. This problem constitutes possibly the major health hazard of this
decade.

An important aspect of the growing concern with the lack of con-
trol of chemicals entering our environment stems from the estimates
of the National Cancer Institute and the World Health Organization
that from 60 to 90 percent of cancer is environmentally induced.

Mr. President, it is no accident that a comprehensive study carried
out by the National Cancer Institute throughout this country found
that the so-called hot spots for cancer are in close proximity to those
locations where the chemical industry is most highly concentrated, and

C721)

722

it is at these locations that the greatest incidence of bladder, lung, liver,
and other cancers have been found. In fact, during the past 5-year
period, there have been in excess of 1 million deaths in this country
from cancer, and the cost of cancer in the United States is now in ex-
cess of $18 billion per year.

It is the goal of this legislation to provide a means of preventing
suffering, death, and environmental damage rather than merely react-
ing to it. It is my view that the conference has done an excellent job of
meeting this goal. This legislation is strong, fair, and comprehensive.
It closes many significant ga])S in our environmental laws.

For example, in the past, the primary stumbling block to agreement
betAveen the House and Senate on the Toxic Substances Control Act in
the Committee on Conference has been in regard to the question of
premarket notification [Sec. 5]. I am extremely pleased to state that
the conference has now agreed on a strong premarket notification pro-
vision which requires that 90 days prior to marketing of new chemicals
or existing substances for a significant ucav use, manufacturei's must
supply EPA Avith information in order that EPA can assess the safety
of these chemicals. None of the other environmental health statutes,
except pesticides, drug and food additiA^e laAvs, and fuel additives, pro-
vide for j)i'emarket rcA^CAv by appropriate regulatory officials. In my
vieAv, this provision is the heart, of the act. This provision aa^II end
once and for all the i^resent situation Avhere chemicals can be marketed
Avithout notification of any governmental body and Avithout any
requirement tliat they l>e tested for safety. Thus, this provision Avould
no longer alloAV the public or the environment to be used as a testing
ground for the safety of these products.

It is important to note that Ave have gained these important^benefits
Avithout placing an unreasonable financial burden on the chemical in-
dusti'v. The chemical industry in this country has groAvn to the point
AA'here its annual sales exceed $100 billion a year. In light of the poten-
tial for protecting the health and environment of the American public
the costs are extremely reasonable.

In the key provisions of the bill, costs are not to be incurred unless
the Administrator determines that they are offset by benefits of at
least the same magnitude. ObA^iously it is not feasible to match these
kinds of determinations just on the basis of quantitatiA^e comparisons.
The burdens of human suffei'ing and premature death are extraordi-
narv. HoAA'ever, this legislation has cn re fully dealt, as I stated before,
Avith the economic asj^ects of the act. In order to delineate the effects of
this act, I Avill uoaa' describe some of the important ]>roAdsions of the
Toxic Sul)stances Control Act.

TESTING OF ('IIE:vrT('AI. SI BSTAXCES AND MIXTURE [SeC. 4]

The conference substitute gi'ants broad authoi'ity to be Administra-
tor of EPA to i-equire testing of chemical substances and mixtui'es.
The conference substitute i-equires the Administi ator to establish test-
ing rules in eithei' of tAvo instances. Fii-st, if the manufacture, distri-
bution, or processing, use, oi* disposal of the chemical substance iiiay
])iesent an unreasonable I'isk of injury to health or the envii'onment
J:nd othei- findings are made, the Administrator must requii'e testin^G:'.
Second, if a substance is oi- Avill be produced in substantial quantl-

723

l ies and it either enters or may be i-easonably anticipated to enter the
environment in substantial quantities or if there is or may be signifi-
cant or substantial human exi)osure, the Administrator must also re-
quire testinor if the other additional findings are made.

An exemption procedure is ])rovided to avoid the submission of
duplicative data ))V a person subject to a testing lequirement. In those
instances, a cost-sharing procedure is also provided.

An interagency advisory committee is established to assist the Ad-
ministrator in establishing testing priorities.

MAXUFACTURIXG AND PROCESSIXG XOTICE [ScC. 5]

Ninety days prior to fiist manufacture, manufacturers of new chem-
ical substances must give notice to EPA. In addition, manufacturers
or processors of chemical substances for a use which has been iden-
tified by the Administrator as a significant new use must also give
notice. A variety of information is required to be submitted with the
notice, including such data as the identity of the chemical, categories of
proposed use, estimates of the amount to be manufactured or processed,
a description of byproducts, any test data in the possession or con-
trol of the ])erson giving notice, and a description of any other data
known by the person or reasonably ascertainable.

The requirement that manufacturing and processing notices be
given for significant new uses of chemical substances is extremely im-
portant. As chemical substances fi-equently are not manufactured in
laige volumes oi* for a large number of uses initially, the authority
to lequire notification for these substances as uses mount or as vol-
umes increase is extremely important. A key element in the Admin-
isti ator's determinations of significant new use is tlie requirement that
he consider health or environmental threats that may arise through
the manufacture, ])i-ocessing, distribution in commerce, or disposal of
the chemical substance.

Thus, notification will occur with respect to significant new threats
arising from any of these activities if it is associated with a different
use. Of course, changes in the types of exposure, volume of the sub-
stance manufactured o)* processed, and other factors will obviously
go into detei-mination by the Administrator of what is a significant
new use. The Administrator is expected to promulgate rules concern-
ing significant new uses by categories in order to avoid a multiplicity
of rulemaking proceedings.

Determinations of what is or is not a new chemical substance is inade
through the establishment of an inventory of chemical substances
under section 8(b). If a substance does not appear on the inventory,
then it must go through premarket notification 90 days prior to first
manufacture.

As chemical substances are rarely manufactured in an entirely ])ure
state, it is intended that leferences to chemical substances include
contaminants thereof. The statement of manageis states explicitly
that the Envii onmental Protection Agency is to establish guidelines
on how the contaminant question is to be treated for purposes of the
different sections of the act. With respect to the Section 8(b) inven-
tory and its relationship to ])remarket notification, EPA must be care-
ful" not to define contaminants too broadly with respect to substances

724

on the section 8(b) inventory. If EPA were to do so, then there would
be no premarket notification for chemical substances with new or
different contaminants than those which appear on the section 8(b)
inventory.

While it may be appropriate to inckide all contaminants within
the requirements of a rule under section 6(a) or other provisions along
witli the principle chemical substance, it may be inai:)propriate to do
so insofar as it relates to the premarket notification provisions of
section 5.

EPA is required to take action against a chemical substance under
section 5 if there is an insufficient amount of data available and the
substance either may present an unreasonable risk of injury or re-
sults in substantial environmental exposure or significant or substan-
tial human exposure. The procedure for prohibiting or limiting a
chemical substance on this basis is the same as the procedure now
in existence under section 701(e) of the Federal Food, Drug, and
(^osmetic Act. Under that procedure as it will be applicable to this
act, the Administrator is required to issue a proposed order prohibit-
ing or limiting the manufacture, processing, distribution in commerce,
use, or disposal of the substance. If he makes the finding within the
last 45 days of the premarket notification period, or an extension he
is required to seek an injunction to prohibit or limit the substance.

If a proposed order is issued prior to the last 45 days of the noti-
fication period, the manufacturer or processor is authorized to file,
within 80 days after the manufacturer or processor has received no-
tice, specific objections with the Administrator. If those objections
are filed, then the Administrator must seek an injunction in otder to
halt or limit the substance.

The objections filed with the Administrator must be specific and
must state with particularity the provisions of the order deemed ob-
jectionable. As the entire procedure is similar to that contained under
section 701(e) of the Federal Food. Drug and Cosmetic Act, the pro-
vision will operate in the same manner.

For example, under the case law developed pursuant to that sec-
tion—Pfizer Ine, V. Richardson, C.A.2, 1970, 484 F. 2d 586— as it ap-
plies to this act, the Administrator may require that reasonable
grounds be stated by a manufacturer or processor as a condition for
recognizing that objections have been filed. Thus, under the proce-
dure adopted by the conference, the Administrator may indeed exer-
cise flexibility in determining whether or not objections have been filed
and thus whether or not his order is rendered ineffective.

If the Administrator determines that valid objections have been
filed, then he is required either to seek an injunction or to dismiss
the order. If he decides the objections are not reasonable, then the
proposed order becomes effective upon the expiration of the premar-
ket notification. Any manufacturer who disagrees with the Admin-
istrator's determination that the grounds are not reasonable is en-
titled to judicial review under chapter 7 of title 5, Ignited States Code.

The conference substitute also provides a means for the Adminis-
trator to take inunediate action against those substances for which
there is a reasonable basis to conclude that a substance presents, or
will present, an unreasonable risk of injury to health or the environ-
ment. The Administrator must either make a rule immediately effec-

725

five whicli Jimits the manufacture, processinor, or distribution in
commerce, or whicli imposes use or disposal requirements of a chem-
ical substance or he must seek an injunction in court. If he wishes to
completely prohibit the manufacture, processing, or distribution in
commerce of a substance, he must follow the procedure outlined above
as it relates to situations where there is an insufficient amount of data.

Thus, the <roals of the Senate bill, which were to orive the Admin-
istrator wide flexibility during the pre-market notification period to
halt or limit cliemicals, has been preserved. This is the heart of the
bill.

In each instance described above where the Administrator must
give notice to a manufacturer or processor of a proposed order, actual
notice in writing must be provided. As a manufacturer or processor
may refuse to receive written notice of the propoj^ed order and thereby
thwart the actual notice requirement, if such a situation arises, and
the Administrator has made a reasonable attempt to give notice, the
notification procedure should be deemed to be fulfilled.

The conference substitute contains a requirement that the Admin-
istrator respond during the premarket notification period if the
Administrator declines to take action during it to halt or limit a
chemical substance. This was included in the Senate bill and has been
retained for the most part in the conference substitute.

It is intended that the response as outlined in the report of the
Senate Committee on Commerce be utilized not only for responses
•luring the premarket notification period but the required response
of the Administrator to designated chemicals under the section 4 in-
teragency advisory committee list as well. In the context of premar-
ket notification, it is anticipated that the Administrator's response
must be, if action is not taken, that no unreasonable risk exists or
tiiat a testing need does not exist. In the context of the section 4 ad-
visory committee list, the response should be, if the Administrator
does not initiate a testing requirement rule, that none is necessary.

PROTECTIOX FROM UXREASOXABLE RISKS [ScC. 6]

The conference substitute, as did the Senate bill, require the Ad-
ministrator to impose restrictions on a chemical substance or mixture
if the Administrator finds that such substance or mixture presents, or
will present, an unreasonable risk of injury to health or the environ-
ment. A variety of regulatory tools are available, ranging from com-
j)lete prohibitions to mere labeling requirements.

The conference substitute also contains an important provision re-
lating to the controls of PCB's [Sec. 6(e)]. Within 1 year, PCB's
mav not be used in any manner other than in a totally enclosed man-
ner unless the Administrator makes specific exceptions. Withm 2 years,
manufacture is to cease and within 21/2 years, processing and distri-
bution in commerce. Again, exceptions are provided.

The conference substitute also contains the authority to act against
imminent hazards, which is defined as an unreasonable risk of serious
or widespread injury to health or the environment.

It should be noted' that a specific reference is made m the imminent
hazard authority and in the authority to take action under section b
rhat articles centaining substances or mixtures may be reached as

726

well. While this is meant to ease the burden on the Administrator
and the court in reaching such articles, it should in no way be inter-
preted as a limitation on the authority of the Administrator or the
court to act against chemical substances and mixtures, as clearl}^ de-
fined in section 3 of the conference substitute.

IMMINENT HAZARDS AUTHORITY [ScC. 7]

The conference substitute requires the Administrator to seek action
either in court or through administi-ative action when imminent liaz-
ards exist. An immineiit hazard is defined as an unreasonable l isk of
serious or widespread injury to health oi- the environment which is
likely to result before a final rule under section € can protect against
the risk.

REPORTING [Sec. 8]

A vital provision of the conference substitute is section 8, which
describes the authority of the Administrator to require recordkeep-
ing and reports from manufacturers oi' processors, and in some cases
other pei'sons, with respect to information concerning chemical sub-
stances. The authority will be vital in determining what substances
are being produced, what they are being produced for, and other
information.

The general reporting requirements generally reach manufacturers
or processors of chemical substances. Manfuacturers or processors of
mixtures or chemicals produced in small quantities for research pur-
poses are to maintain records and submit reports to the Admijiistrator
as the Administrator determines is necessary for the effective enforce-
ment of this act. Used in this context, the phrase "elTective enforcement
of this act," and elsewhere in the bill as well, should be used broadly.
It is not meant to imply that such records and reports may only be
required in order to effectively bring an enforcement action under
section 16. Rather it should be interj^reted to mean reciuirinir records
and gathering reports so that the authorities of the act may be indeed
invoked, if necessary.

JUDICIAL REVIEW [Sec. 19]

Among the more important provisions is the section calling for
judicial review of certain rules promulgated under tlie act. Of im-
portance is the fact that certain of them receive "substantial evidence"
review by reviewing courts. Wliile the "substantial evidence" i-eview
extends to rules under section 4(a), it is not anticipated that this re-
view standard Avill unduly hinder the Administrator. As testing
requirements under section 4(a) will frequently be based on an insuffi-
ciency of data, it would ordinarily not be appoi-priate for the Admin-
istrator to develop "substantial evidence" of that insufficieny.

Xonetheless, if a reasonable effort to find data which indicates that
the health or enviromnental effects of a chemical substance may be
determined and does not find such information, the Administrator
should be deemed to have fulfilled the substantial evidence require-
ment. With respect to substances for which premarket notification is
required, the Administrator should not be required to look beyond the
notification documents.

727

attorney's fees

Under the judicial review procedures, as well as those relating to
citizens' petitions, citizens' suits, and the rulemaking procedures under
section 6, prgvide for the award of attorneys' fees. A brief discussion
of those provisions would be appropriate.

The conference substitute before us contains important provisions
relatin/i" to the award of attorneys' fees. These provisions, including the
judicial review provisions of section 19, the citizens' suit provisions
of section 20. and the citizens' petition provisions of section 21, allow
a court to award costs of suit and reasonable fees where appropriate.
So that the legislative history accompanying these provisions is con-
sistent, I ask unanimous consent that a discussion of these provisions
by the distinguished Senator from California (Mr. Tunney) which
ap])eared in the Congressional Record of March 26, 1976, be printed
in the Record at this ]>oint.

There being no objection, the excerpt was ordered to be printed in
the Record, as follows :

Legislativk History To Accompany Model Attorneys* Fees Provision

Mr. Ti NNEY. Mr. President, attorneys' fees provisions appear in a number of
places throughout this legrislation. These provisions allow a court to award co.sts
of suit and rea.'^onable fees where '"appropriate." These provisions are very im-
portant to the proper vindication of rights under this legislation. I would like to
offer .some explanation which in my oi)inion will clarify the operation of those
provisions.

Until recently, the courts often provided for effective actions by private
citizens through the award of costs and fees, even in the absence of specific
statutory authorization, under the "private attorney general" rationale. How-
ever, in a recent decision. Alyeska Pipeline Service Co. against Wilderness
Society, the Supreme Court held that —

"Court lacked d.iscretionary power to award attorneys' fees to petitioners who
sought to vindicate 'important statutory rights for all citizens' . . . unless there
was specific statutory authorization for such awards . . . The circumstances under
which attorney's fees are to be awarded and the range of discretion in the
court for making those awards are matters for Congress to determine."

In light of that decision, the fees and costs provisions of this legislation follow
the precedent of over 50 Federal statutes in permitting fee shifting by the courts.

This provision would allow an award of fees and costs to any party when
"appropriate." a word which should liberally construed to effectuate the purposes
of this act. Thus, in typical circumstances, tlie court should follow prevailing case
law which holds -that a successful plaintiff "should ordinarily recover in at-
torneys" fee unless special circumstances would render such an award unjust."
Newman v. Piggic Park Enterprises, Ine., 390 U.S. 400, 402 (1968) (per curiam).
"Plaintiff" in the sense is used to mean the parties seeking to enforce the rights
granted by this section and can include an interA^enor, or a defendant in some
cases. See e.g.. Shelhy v. Jyranicr, 334 U.S. 1 (1948).

In exceptional circumstances, fees and costs might also be awarded to
defendants where they must "defend against unreasonable trivalous. meritless or
vexations actions * *"* T'nifed S!tafes Steel Corp. v. United States, 385 F. Supp.
3^0. 318 (W. D. Pa. 1974). Where plaintiff's proceeding is brought in good faith
or on the advice of component counsel, fees and costs would ordinarily be denied
to a prevailing defendant. Riehardson v. Hotel Corporation of Ameriea, 332 F.
Supp. 519 (E.D. La. 1971). aff'd. 408 F. 2d 951 (5th Cir. 1972). The standard for
awarding fees and costs to a prevailing defendant is not the same as for a
plaintiff because, if it were, the risk, to the average citizen of bringing suit
under this section would be so great it would di.scourage such suits.

Fees and costs would be awarded to a "successful plaintiff" under this provision
where there was a final court order granting tlie relief requested by plaintiffs, or
as a matter of interim relief jiending the outcome of the case. The provision does
not require the eritry of a final order before fees or costs may be recovered. See

728

Bradley v. School Board of the City of Richmond, 416 U.S. 606 (1974) ; Mills v.
Electric Auto-Lite Co., 396 U.S. 375 (1970). Such awards are especially im-
portant where a party has prevailed on an important matter in the course of
the litigation even where he does not ultimately prevail on all the issues. See
Bradley, supra, and Mills, supra. For purposes of the award of fees and costs, it
is "appropriate" to make awards where the parties have vindicated rights
through a consent judgment or without formally obtaining relief, or where such
award is in the public interest without regard to the outcome of the litigation.
Kopet v. Esquire Realty Co., 523 F. 1095 (2d Cir. 1975) ; Parham v. SoutMcestern
Bell Telephone Co., 433 F. 2d 421 (8th Cir. 1970) ; Richards v. Griffth Ruhler
Mills, 300 F. Supp. 338 (D. Ore. 1969) ; Thomas v. Honeybrook Mints, Inc., 428 F.
2d 931 (3d Cir. 1970).

By specifying a general rule for the amount of fees to be awarded,
this provision requires tlie method of calculating fees be no different than that
now being utilized in other fields of law as, for example antitrust and securities
regulation litigation. The "actual time" spent is that reasonably calculated to
advance the client's interest. The Stanford Daily v. Zurcher, 64 F.R.D. 680 (X.D.
Cal. 1974). and the amount can be adjusted for factors including inter alia, the
centingent nature of the success or the quality of the work performed. Lindy Bros.
Builders v. American Radiator d Standard Sanitan/ Corp., 4H7 F. 2d 161 (3d Cir.
1973), on remand, 382 F. Supp. 999 (E.D. Pa. 1974), or benefits to the public
from the suit. Davis v. County of Los Angelex, S E.P.D. 9444 (CD. Cal. 1974).
Fees should not be reduced merely because the attorneys are salaried employees
of public interest and or foundations-funded law firms.

Fees and costs awarded under this provision may be assessed against the
United States, including any of its agencies and officers acting in an official
capacity, the same as against a private party.

Finally, since expert witnesses are often needed to make an adequate
presentation to a court such fees are also provided for in this statute. They
would be in addition to those now provided in 28 U.S.C. 1920 and 28 U.S.C. 1821.

The policy outlined above should apply to the procedares under section 23
to the extent applicable.

Mr. ^Iagxusox. In addition, so that the lefjislativo history may be
consistent in both the House and the Senate with respect to the costs of
participating in a rulemakino- proceeding under section 6, 1 ask unan-
imous consent that a portion of the report of the House Interstate
and Foreign Commerce Committee — report Xo. 9-l:-1341 — regarding
the award of the costs of participating in a rulemaking proceeding
under section 6 be inserted in the record at this point.

There being no objection, the excerpt was ordered to be printed in
the Record, as follows:

Excerpt of Report

In order to provide to the extent possible that all relevant interests be
represented in rulemaking proceedings so that the rules adopted best serve the
public interest, the Administrator is authorized to provide compensation for rea-
sonable attorneys fees, expert witness fees, and other cns;ts of participating in
the rulemaking proceeding. Such fees and costs may be provided to any person
who represents an interest which will substantially contribute to a fair deter-
mination of the issues to be resolved in the proceeding if the economic interest of
the person is small in comparison to the costs of effective participation by that
person in the proceeding or if the person demonstrates to the satisfaction of the
Administrator that the person does not have sufficient resources to participate
in the proceeding in the absence of compensation. In determining if a person
represents an interest which will substantially contribute to a fair determination
of the issues, the Administrator is to take into account the number and com-
plexity of the issues and whether representation of such interest will contribute
to widespread public participation and to representation of a fair balance of in-
terests for the resolution of the issues.

In determining whether compensation should be provided and the amount of
such compensation the Administrator shall take into account the financial
burden wliich will be incurred as a result of participation. However, the Com-
mittee does not intend to imply that in all instances a person must be able to

729

demonstrate a financial burden h^efore the Administrator may provide the per-
son with compensation Demonstration of financial burden is required unless a
person has an economic interest which is small in comparison to the costs of
effective participation in the proceeding. Thus when the economic interest is
small, no showing of financial burden is required. However, in light of the possi-
bility that there nuiy be competing reciuests for assistance in connection with
proceedings under this section, a consideration of financial burden will be
relevant in determining who should be tlie recipients of compensation and the
amount of comi)ensati()n. In considering the financial burden to be incurred, the
Administrator should not look solely at the costs of participating in the section
G proceeding, but should instead view such costs in light of the overall activi-
ties of the person api)lying for compensation and the person's resources. For ex-
ample, a person ro(iuesting compensation could show that such person represents
interests which nuiy require participation in other judicial or administrative
proceedings and that such participation might have to be curtailed or limited
because of a commitment of resources to the proceeding with respect to which
such request made and the Administrator should consider such information.

A determination reasonable attorneys' and exi>ert witnesses' fees should not
be influenced by the fact that a person is a salaried employee of a public interest
or foundation fundetl organization. The Committee intends that reasonable fees
be those which are commen.surate with those at which such professionals would
normally be compensates! for performance of similar services. The fact that
attorneys or experts may be employed by citizens' groups or foundations at
salaries or hourly rates which may be below the standard commercial rates such
profes-sionals might normally receive is not relevant to any computation of the
rate of compensation under the bill. Even in situations where a lawyer or expert
initially renders services without expectation of receiving any compensation,
fees are to be awarded at prevailing market rates. It may well be that an
attorney will agree to provide representation of an interest in a proceeding
because of a belief that such rejiresentation furthers a public interest. Rep-
resentation of such interests should not have to rely upon the charity of counsel.
This intent reflects the well-settleil judicial rule that fee awards are to be made
without reference to the fee arrangements that exist between an attorney and
client. As the court stated in Miller v. Amusement Enterprises, Inc., 426 F. 2d
532. r>38-r).30 (5th Cir. 1970) :

"What is required is not an obligation to pay attorneys' fees. Rather what —
and all — that is required is the existence of a relationship of attorney and client,
a status which exists wholly independently of compensation."
Similarly, the United States Court of Api)eals for the District of Columbia
Circuit has ruled that fee awards in litigation undertaken to further the public
interest must be computed so as to bring the attorneys' rate of compensation up
to that of the prevailing market rate. See Wilflcrness, Society v. Morton, 495
F. 2d 1026. 1037 ( l^.C. Cir. 1974). reversed on other grounds, sub nom. Alj/eska
Pipeline Co. v. Wilderness Society, 421 U.S. 240 (1975). and Natiwial Treasury
Einployees v. Xixo-n, 521 F. 2d 317, (1975). Provision is made in section 19 (judi-
cial review), section 20 (citizen's civil action), and section 21 (citizens' petition)
for the award of reasonable attorneys* and expert witnesses' fees in actions under
such sections. The considerations enumerated here respecting a determination
of the reasonablenes.s of a fee also apply to those sections.

Mr. ^Iaoxusox. As the award of attorneys' fees under section 6,
and the provisions of sections 19, 20 and 21 is not restricted to plain-
tiffs or to snccessfnl parties, an additional explanation of what is in-
tended with i-espert to these provisions is also appropriate.

Tt is not the intention of these 7-)rovisions to provide an award for an
individual or a o^roup if that individual or srroup may stand to irain
sionifioant economic benefits through participation in the proceedine:.
Tt is also intended to discoura<?e individuals who may stand to benefit
economically from the proceeding from ioinin^- with other individuals
for the purpose of fonning an organization to obtain compensation for
participation in an agencv proceedinof under this act. A group or
organization that has members wlio mav have some economic interest
in a proceedi^ig would not necessarily be excluded, particularly if that

79-313 0 - 77 - 47

730

interest cannot be said to have motivated those members' involvement
in that group or organization.

It is not intended that the provisions support participation of per-
sons, including corporations or trade associations, that could otherwise
afford to participate or whose economic interest in the outcome of a
proceeding is not insubstantial. Whether or not the person's resources
are sufficient to enable participation would include consideration of
the person or group's potential utilization of tax deductions for par-
ticipation in litigation as a business expense, his cun'ent financial con-
dition, and assessment of the likelihood that the person would seek to
participate in the proceeding whether or not compensation w^as
available.

AVAILABir.ITY OF INFORMATION [SeC. 14]

The provisions of section 14, concerning the release of information
to the public obtained by the Administrator under the act, generally
follows other statutes of this nature. Some important distinctions
arise, however. Under the conference substitute, for example, the Ad-
ministrator is required to release information to the public if necessary
to protect against an unreasonable risk of injury to health or the
environment.

Moreover, with the exception of process data and mixture com-
position, the statute states clearly that health and safety studies and
information bearinir on them are not prohibited from disclosure and,
under the terms of the Freedom of Information Act, must be disclosed
if requested. Moreover, this kind of information is required to be
made public when it is received by the Administrator under the pro-
visions of section 4, concerning the testins: of chemical substances and
mixtures, and section 5, premarket notification.

A procedure is provided for the designation by persons submitting
data which is entitled to confidential treatment under the provisions
of section 14. Before releasing data so designated the Administrator
must give 30 days notice to the person submitting it.

The desisniation authority does not extend to data from health and
safety studies. Moreover, if the Administrator proposes to release
information if necessary to protect as^ainst unreasonable risk of injury
to health or the environment, a 15-day notification will suffice. If it is
necessary to protect against an imminent, unreasonable risk of injury
to healtii or the environment, a 24-hour notice will suffice.

While the notice is to be made in writing by certified mail — imless
it is necessary to protect against an imminent, unreasonable risk — this
procedure should not prove onerous to the Administrator when desir-
ing to release. As the requirement that notification be in writinir by
certified mail, it is obvious that by refusino^ to accept a certified letter
from the Administrator, a person may effectively thwart this proce-
dure. Thus, it is intended that the notification will be deemed to be
satisfied if reasonable attempts have been made to deliver the notifica-
tion to the person submitting information. A return receipt is not
required.

Mr. President, the Toxic Substancos Control Act represents over
5 years of work by the Congress. It is high time that this program
got underway without further delay. I urge the acceptance of the con-
Terence report.

731

Mr. Hartke. Mr. President, it is rare that the Senate has the oppor-
tunity to establish a program for the protection of health and the
environment which enjoys the wide support as does the Toxic Sub-
stances Control Act. The conference report which is now before the
Senate is supported not only by environmentalists and organized
labor, but is also supported by many elements of the chemical
industry.

This is especially significant given the bitterness and divisiveness
which has sui"r-ounded this issue through its 6-year history in the Con-
gress. Tlie differences between the Senate position and the House posi-
tion were extraordinary in the early years of this bill's history.
Nonetheless, in this Congress, as evidence of the chemical threat has
continued to grow, the principles for which the Senate has fought so
long have become a reality.

While the strugirle has continued on this bill, approximately 5,000
new chemical substances have reached commercial fruition. Moreover,
the hazards associated with exist inji chemicals like hea^^ metals, vinyl
chloride. PCB's, PRB's, and BCME have all dramatically come to the
public's attention. From the slaughter of cattle in Michigan due to
PBB contamination to the condemnation of large quantities of fish
from Lake Michioran because of PCB contamination, the environ-
mental and health threat due to chemical substances has continued
to bo etched in our consciousness.

During this period, there have been in excess of 1 million deaths
from cancer. Over a million infants have been born with birtli defects
of one type or another. Tn fact, approximately 7 percent of all infants
born in this counti-y have some sort of ]~)hysical or mental impairment.

While T luid some reservations with respect to this lesrislation Avhen
it was ori.o-inallv introduced in the first session, I am happy to lend
mv enthusiastic support for it now and was pleased, alonir with the
distin^niished Senator from California, to be an original cosponsor of
the bill as it passed the Senate.

The essential elements of the pi-ogram which were contained in the
Seiiate bill liave been preserved in the conference substitute. Broad
authoritv to require testing of known and existing substances is pro-
vided as is appropriate authority for the Administrator to act during
the premarket notification period with respect to new substances and
si'^nificant new uses of existinjT sul>stances.

Authority is given to the Administrator, ^vith sufficient safeguards
against administrative abuse, to take action against substances found
to pose unreasonable risks.

Importantly, the Administrator will have clear direction as to when this
statute is to be nsed as opimsed to the other authorities or authorities possessed
by other agencies. While the direction is clear in the statute, safeguards hare
been in'-orporated which Avill prevent endless litigation on this point. Reporting
authoritv is authorized so that the Administrator may require that records be
kept and reports made with respect to the fuU range of activities associated with
the manufacture and processing of chemical substances. . ^

Health and safety data generated bv manufacturers. r)rocessors, or distributors
in commerce shall be retained and listed with the Administrator. This is designed
to prevent data available to the industry from being buried as it was alleged
in the case of vinvl chloride. Records must b^ kept of anv significant adverse
reaction to health or the environment cau«ed by a chemical substance and sub-
mitted to the Administrator upon request. .a • f

Citizens are authorized to bring suit against violators of the act and against
the Administrator for nonperformance of mandatory duties. Citizens petitions

732

are authorized which will force the Administrator to be more responsive to the
needs of citizens in the establishment of rules under the act.

Protections have been built in which will prevent undue burdens on small
business. For example, the reporting requirements of section 8 of the confer-
ence substitute may not be involved for small businesses unless the small busi-
ness is covered by a proposed or a final rule or order under various sections of
the act. While EPA must have access to reporting information from small
business for the purpose of developing appropriate restrictions and requirements
under the act, this provision will ensure that EPA not do so arbitrarily.

Moreover, the Administrator is given the authority to exempt persons rrom
the premarket notification requirements applicable to new chemical substances
if the Administrator determines that a substance will not present an unreason-
able risk of injury to health or the environment. So that manufacturers or proc-
essors do not have to submit duplicative test data under section 4, an exemption
procedure is also provided. Two explicitedly stated bases for determining what
amount of reimbursement will be required is the market shares of the company
seeking the exemption, and its competitive position. Thus, a small manufacturer
or Drocessor will not be unduly burdened by testing costs.

The broad acceptance that this legislation has now received is an
indication that the rather outlandish estimates of the costs of this legis-
lation made last year by the chemical industry have been largely dis-
counted. While estimates from Dow Chemical ranged up to $2 billion
per year, and the estimates of the Manufacturing Chemists Association
ranged from $340 million to $1.4 billion per year, EPA estimated that
the cost would range from $80 to $140 million per year. The General
Accounting Office, at the request of the Committee on Commerce,
agreed largely with EPA's estimate and stated that the cost would
probably run between $100 and $200 million per year. This cost is
obviously very slight when compared to the tremendous benefits not
only in direct expenditures in health care, but with respect to pain and
sutfering as well.

And while this legislation has gained acceptance by the mainstream
of the chemical industry, it is also acceptable to environmental, public
health, and labor groups, such as the AFI^CIO, the Sierra Club, En-
vironmental Action, Congresswatch, and others.

It is rare that this kind of combination of support exists behind any
program, let alone a program designed to protect against chemical
threats to health or the environment. It would be a great disservice to
the people whom we in the Senate serve to do anything other than ap-
prove this conference report by a resounding majority. I urge my col-
leagues to do so.

Mr. Moss. Mr. President, I support my chairman, the chairman of
the Committee on Commerce, in his remarks concerning the Toxic
Substances Control Act.

Mr. Magxusox. Mr. President, if the Senator will yield just a mo-
ment, I wish to add that the Senator from Utah, the Senator from
California (Mr. Tunney ) , and the Senator from Indiana (Mr. Hartke)
have played a very important role not only in the hearings on this bill,
but in carrying this bill through the Senate and the conference. As I
say, there were many, many meetings of the conferees and they were
stalwarts in keeping the Senate bill as intact as possible. We did have
to make some concessions, but had it not been for them, I do not think
we would have the kind of a conference report that we have before the
Senate today.

I ask unanimous consent, since he is necessarily absent, to have
printed in the Record a statement from the Senator from California
(Mr. Tunney) on this conference report.

733

There bein^ no objection, the statement was ordered to be printed in
the Record, as follows :

Statemlnt of Senator Tuxney .

Oftentimes we in the Senate are tempted to place labels on legislation such as
'"landmark"', "historic", or some other suitable adjective.

While those words are obviously overworked in this great body, I nonetheless
feel that they fit the Toxic Substances Control Act very well.

As the Senate today considers the conference report on the Toxic Substances
Control Act, it would be well to reflect just for a few moments on the tortuous
path this legislation has followed in getting to this point.

The legislation was first introduced in the spring of 1971 as a result of a report
from the Council on Environmental Quality which indicated that there was not.
at that time (and there still isn't), a statutory authority in existence which would
deal comprehensively with chemical substances such as phosphates in detergents,
mercury and other heavy metals, asbestos , and so on. The proposal at that time
was viewed largely as an environmental bill designed to plug gaps that existed
in the environmental control framework.

It soon became readily apparent that this authority had a far greater utility.
Most importantly, it can serve as the vehicle for establishing whether or not a
new chemical substance (or a significant new use of an existing substance) has
been ade<iuately tested prior to first manufacturing and if a suflicient amount of
data exi!<ts. to take appropriate regulatory action. It is at this point in the life
of a chemical substance that appropriate controls may most easily be imposed.
It is at this time that the costs in terms of occupational danger, damage to the
environment, and capital outlays are at their very lowest. We have found time
and time again, as is the case with chemicals like vinyl chloride, that the imposi-
tion of necessary controls when a substance is in place in the channels of com-
merce is extremely difficult.

It is around this key jirovision that much of the controversy has raged over the
life of this legislation. In 1972, the Senate passed the legislation with a strong
pre-market notification provision. Unfortunately, the House bill did not contain
a similar provision, and the bill died l>ec-ause time ran out in the 92nd Congress.

The provision also was the subject of extreme controversy in the 93rd Congress.
Again, the Senate passed a strong provision and the House did not. Tliat bill
remained before a committee of conference for approximately one and one half
years, without resolution.

In this Congress, there has been significant movement on the part of the House
of Representatives which has resulted in the agreement we have before us today.

The many tragedies which have come to light within the past 3 years indicate
that while it has been a long and difficult task to get a strong pre-market notifica-
tion provision, it has been worth it. Scientific journals and the popular press have
been filled with accounts of how chemicals like vinyl chloride, BCME, PCB's, and
asbestos are causing far graver threats to human health than we had previously
thought. All of these chemicals have now been implicated as causing cancer and
other grave health effects. Nonetheless, all of them are also used in very large
quantities and hiive become so intertwined with the economic fabric of this coun-
trv that control now is extremely difficult.

While many of the health effects to which human beings are at risk has declined
in recent years, cancer has not. In fact, cancer incidence has been estimated in
1975 to be some two and a half percent above the previous year. That much of the
increased incidence in cancer is due in major part to the use of chemicals in this
country is largely beyond debate. The National Cancer Institute has estimated
that from ,50 to 90 percent of all cancers are environmentally caused. While much
of this is due to cigarette smoking, much is not.

Had this statute been in existence when chemicals now known to cause major
health effects besan production or as their uses mounted, we could well have
avoided much of the pain and anguish that accompanies occupational disease and
public health and environmental threats generally. It is extremely important to
recognize that the conference substitute before the Senate today contains the
authority for the Administrator to require premarket notification before manu-
facture or processing of substances for significant new uses is begim [Sec. 5j.
Thus, as the volume of a chemcial substance mounts, or as its uses change. EPA
will have the authority to make sure that test data is available and that appro-
priate restrictions are imi>osed prior to the exposure taking place.

734

I am happy to say that I have been a principal sponsor of this legislation since
my joining the Committee on Commerce nearly four years ago. During that time,
I have chaired day after day of hearings during which the grim tale of the kinds
of human suffering that chemicals may cause has unfolded. Statistics concerning
disease and death suddenly take on very clear meaning when one is seated across
a hearing table from the surviving family of workers who have died from chem-
ically induced cancer.

The essential elements of a strong toxic substances control program are in-
cluded in the conference substitute. It provides for premarket notification for all
new chemical substances, and it provides for adequate authority during that
period to take action. If the Administrator finds that there is insuflScient data or
experience with respect to a chemical and the substance may present an unreason-
able risk or if he finds merely that a substance will result in substantial environ-
mental or significant or substantial human exposure, the Administrator must
issue proposed orders to halt or restrict the chemical pending the development of
the data. While the Administrator must go to court to get an injunction if objec-
tions are filed by the manufacturer or processor, it is clear that the Administrator
will have a great deal of flexibility to determine whether or not the objections are
valid.

Moreover, if the Administrator finds that a substance presents or will present
an unreasonable risk of injury to health or the environment, the Administrator
must act to prohibit or limit the chemical substance during the pre-market noti-
fication period.

Importantly, the conference substitute contains adequate provision for citi-
zen input to the administrative process. Citizens may bring suit against violators
of the Act if EPA has not acted against them and to force EPA to act with
respect to nondiscretionary duties. In addition, citizens may petition EPA for the
issuance of certain rules and orders under the Act. If EPA does not respond
within 90 days, or responds in the negative, citizens may bring suit to force the
Administrator to initiate the action. All of us have an interest in ensuring that
agencies of the Federal Government are more responsive to the needs of citizens.
The provisions contained in the Toxic Substances Control Act should be an ef-
fective means to ensure that bureaucratic lethargy does not prevent the appro-
priate administration of this vital authority.

I am delighted that the Senate today will take final action on an authority
which Russell Train, Administrator of EPA, has called the most important
environmental measure before this Congress.

I could not agree more.

Mr. Moss. Mr. President, as was pointed out by the Senator from
Washington, this is a complicated and difficult bill to write and on
which to reach an agreement with the House of Representatives. But it
is of immense importance to the health and welfare of our people and
to the environment in which we live. Each day's newspapers carry some
additional story about problems that we have with chemicals and toxic
substances that, in various ways, impinge upon the health of our people
and contaminate our water supply, our food supply, and create other
health and environmental threats.

This bill will now establish a control mechanism, so that we can be
sure that we are not exposing humans and the environment to toxic
substances before we can determine whether or not they have deleteri-
ous effect and before effective action can be taken.

AVe live in an age of chemistry and technology. We do so many good
things with chemistry and technology, but we have been quite oblivious
to what the total effect of these new chemical processes may be. We are
now attempting to be certain that nothing is loosed upon our people in
the way of cliemical or toxic substances without our knowing what the
fallout will be. If it is going to be damaging, then, of course, it m^ist
be prevented.

I wanted to add just that brief comment because this has been a long
and difficult process. The conference was lengthy, but the conference
report which is before the Senate represents a reasonable compromise
with the House of Representatives, and I urge its adoption.

735

Mr. Magxusox. Locally, of course, we have been reading a great deal
about the disaster involving Kepone. It is precisely this type of disaster
that this bill is designed to prevent.

Mr. Moss. Right.

Mr. ^lAGxrsox. >.o question about it. That is why the law is so im-
portant. In the future things like this almost unbelievable disaster,
will not happen.

Mr. Pkarsox. Mr. President, agreement by the Senate and House
conferees on a compromise Toxic Substances Control Act marks a
major achievement of the 94th Congress. For nearly 6 years, legislation
regarding the control of toxic substances has been before the Congress ;
during the 93d Congress, Senate and House conferees were unable to
agree on a compromise bill. During that same time period, an estimated
5,000 new chemicals have been introduced into the commercial market-
place and have served to increase the number of known different chem-
icals to over 2,000,000. Final congressional action on the Toxic
Substances Control Act comes at a time when the need to protect the
American public from the harmful effects associated with toxic chem-
ical substances has never been greater.

As my colleagues will recall, the Senate passed S. 3149, the Toxic
Substances Control Act, on March 26, 1976, by a vote of 60 to 13.
Final House passage on a very similar bill, H.iR. 14032, occurred on
August 23, 1976, by a 319 to 45 vote. The conference report that we
are now considering was then forged by the respective Senate-House
conferees and represents a compromise that has been unanimously
agreed to by all conferees.

The vast majority of commercially available chemicals have served
to enormously increase our standrad of living and have been in large
measure responsible for dramatic improvements and advances in agri-
cultural production, medical research and technology, and a myriad of
new and innovative products available to the consumer. There are also,
however, a small number of highly toxic chemical substances that
have been commercially produced and marketed that have been re-
sponsible for enormous damage. The tragic human suffering and en-
vironmental degradation associated with such chemical substances as
Kepone, vinyl cliloride, mercury, and PCB's are well known. To a
large degree, our continued failure to adequately test and regulate
chemical substances, both during the premarket period and after the
chemical is in commercial production, has been responsible for such
tragedies. Enactment of the Toxic Substances Control Act will enable
this Nation to gain the type of control necessary to adequately and
eifectively deal with this problem.

Enactment of this bill would:

Provide the means by which adverse affects on human health and
the environment can be ascertained and appropriate action taken
before chemical substances are first manufactured commercially and
introduced into the marketplace.

Provide for an ongoing mechanism that would ensure that the EPA
Administrator would continually have access to new information de^
veloped regarding adverse health or environmental effects associated
with chemical substances. Appropriate action necessary to adequately
protect against unreasonable risks associated with chemical substances
could then be taken.

Provide for specific prohibitions regarding the manufacture, use,
and disposal of PCB's, a widely used and long-lived toxic chemical
substance.

736

Require the Administrator to balance the various costs, risks, and
benefits associated with chemical substances in determining adequate
measures to regulate such substances.

Highlight the need to adequately protect against adverse human
health or environmental effects resulting from the manufacture, dis-
tribution, use, and disposal of chemical substances.

Provide for both citizens law suits and petitions to ensure adequate
and viable public input with respect to the effective administration of
the bill.

Mr. President, the Toxic Substances Control Act as agreed upon
by Senate and House conferees has received widespread and over-
whelming support from all major environmental and consumer pro-
tection groups and major and small chemical manufacturers. The
compromise bill provides for far reaching and much needed controls
over the manufacture, distribution, use and disposal of chemical sub-
stances, both at the critical premarket stage as well as during subse-
quent production stages, while at the same time requiring that the
EPA administrator carry out the provisions of the act in a reasonable
and prudent manner. In addition, and a point emphasized by the
conferees, the Administrator is to use the least burdensome means of
regulating a chemical substance consistent with providing adequate
protection to human health and the environment from unreasonable
risks associated with the manufacture, distribution, use, and disposal
of chemical substances. Thus, adequate and meaningful regulatory
controls are available to the EPA Administrator to protect against
unreasonable risks associated with toxic chemical substances while
at the same time insuring that such regulations take into consideration
the enormous benefits associated with the manufacture and use of safe
chemical substances.

Mr. President, this legislation is long overdue. I strongly ur<re my
colleagues to accept the Toxic Substances Control Act as agreed upon
by the Senate-House conferees.

Mr. DuRKTN. Mr. President, for the past 8 years, the Nixon-Ford
administration has waged an intensive effort to prevent enactment
of meaningful toxic substance control legislation. Their partner in
this effort has been the mammoth petrochemical industry, which has
sent legions of pin-striped lawyers to Capitol Hill to squash anv inter-
est in controlling harmful chemical production. The industry dangled
the threat of thousands of unemployed chemical workers should such
legislation be passed.

Not unrelated, during those same 8 years, at least 1,000 new chemi-
cals were introduced into the environment each year with little or no
knowledge of their long-term health or environmental effects, either
for those working and living near chemical plants, or far away.

Today, we are on the verp-e of enactment of a toxic substance control
bill in the Congress. The bill is a watered-down version of what T
would call meaningful control on the production of new chemicals.
It does not require premarket testing of all new chemicals. It does
not provide for simple administrative mechanisms which the Environ-
mental Protection A^rency will need to effectively keep potentially
harmful chemicals off the market. And it fails to authorize sufficient
funds to assure full implementation even of the bill as written, let
alone more strenuous enforcement and testing.

737

Still, it is a stai-t, and represents years of effort by Senators
Magnuson, Tunney, and Hartke to obtain enactment of the strongest
possible legislation. The bill which came out of the House-Senate con-
ference contained everything that could be squeezed from the chemical
companies and the Republican administration. Despite the advice of
his own Council on Environmental Quality, President Ford may still
consider a veto of the bill.

Before going any further, we ought to put one myth to rest : that
toxic substance control legislation threatens the jobs of chemical
workers. In fact, passage of the current bill would not have been
possible without the vigorous and uncompromising support of the
Nation's labor unions, who have argued rightly that their members
have far more to fear from the production of harmful chemicals than
legislation designed to control them. It is the chemical workers and
their families who suffer the highest rates of cancer, diseases, and
disabilities if a toxic substance is introduced into the environment.
And it is the chemical workers who eventually would be the first to
suffer from multimillion-dollar damage suits leveled against their
companies in the event that another Kepone is thrust upon the market
without so much as a peep from the EPA.

The last 8 years of Nixon-Ford rule have been a disaster for the
environment, and for environmental health. Tons of PCB's were
dumped into our water, our air, and many of the commonplace articles
of daily life — the same PCB's which experts at the National Institutes
of Health now fear may threaten the health of babies who are breast
fed. For the last 8 years, millions of tons of asbestos were produced
without control. The result will be 400,000 asbestos workers dead
during the next 50 years from asbestos-caused cancer.

This legacy of environmental recklessness will be visited upon us,
upon our children, and upon our grandchildren. Toxic substances
introduced into the environment today may have disastrous effects
on our health, our life expectancy, and the biological development of
the species for decades to come. Today's profitmaking chemical may
be tomorrow's birth defect or disease.

Will Lepkowski wrote in the Washington Post earlier this month
about how vital our social and environmental policy is to our children :

What is really at issue is not the ethics of protecting the least among us.
That's an obvious truth. It is the need for ethics covering the entire system to
determine whether the current system is the optimal one for nurturing biological
and social evolution. If the children are getting hurt, it needs a lot of question-
ing. The hopeful thing is that, thanks to scientific ways of understanding nature,
we have the knowledge to start figuring out how to make the system work
betl;er for us. One might call it the ethics of adulthood.

Assuming that no one is safe might make it inconvenient at first
for a lot of chemical companies. But if a fear epidemic of cancer or
birth defects materializes, Lepkowski said, we will certamly regret
not having done something about it while we could have. This is not
an issue that can be put off for another Congress, another set of
committee hearings, another round of bargaining with the chemical
company lobbyists and another round of veto threats with a Republi-
can White House.

Perhaps my concern seems extreme to some. Yet as someone who
takes pride iii the relative clean state of his home environment, I am
also extremely concerned that New Hampshire has one of the highest

738

cancer death rates in the country — sixth highest for women, eighth
highest for men. My obligation is to help find out what is causing
this disproportionate death rate, and what we can do about it. It is
not an obligation to any company, to any industry, but to the children
and future children of New Hampshire.

There can no longer be any question of the impact that chemicals
have on health or the environment. No one knows for sure the causes
of cancer. But we are reasonably sure that between 60 and 90 percent
of cancer is induced by substances in the environment which we eat,
breathe, or touch in some manner.

Chemicals are the No. 1 villain, and have been linked time and time
again to gene mutations and birth defects, cancer, and various heart
and lung diseases.

As a result, we can no longer blind our eyes to a policy which allows
chemical companies to produce chemicals first and ask questions later.
We ought to have all the answers in hand before we allow tons of
unknown substances to be dumped willy-nilly into our environment.
If there has to be a risk taken, then it ought to be by the chemical
companies and their stockholders, not our children and grandchildren
still to be born. Chemicals should be tested first in the laboratory, not
in the environment, and the results should be complete and conclusive.

Of course, we in the Congress could enact the most stringent and
meaningful toxic substance control law, and there still would be no
assurance of good faith execution by the administration, especially
an administration which has danced an 8-year jig with the oil com-
panies which control the bulk of chemical production in this country.
A look at the EPA enforcement record under the Ford administration
is discouraging. It came as no surprise that in J anuary of this year,
three lawyers with the EPA resigned because of the continued failure
of the EPA to take effective action to regulate possible cancer-causing
and other toxic chemicals in our air, food, and water.

The American voter concerned about his health and his environ-
ment does himself little good electing a Democratic Congress com-
mitted to controls and a Republican President dedicated to a free
market in harmful chemicals. In the long run, perhaps we should con-
sider altering our Government structure so that the Congress and the
President are pulling in the same direction, to avoid the stalemate over
this and hundreds of other issues during the past 8 years. In the short
run, I hope the American voter will see the wisdom in electing both
a Democratic Congress and a Democratic President, to carry on the
w^ork that still has to be done in this area.

Toxic substance control legislation will be before Congress next year.
So far, we have enacted a ban on PCB's. We have required that EPA
be notified of all new chemicals that are produced, and given EPA
the authority to stop production of those substances which it can deter-
mine to pose a risk to the health and environment. Hopefully next year,
with the cooperation of a Democratic President the Congress will put
the shoe where it really belongs, and require the chemical companies
to prove all their products are safe for future generations of Americans
before proving they are safe for this generation of stockholders.

Mr. Magnuson. Mr. President, I move the adoption of the conference
report.

The Presiding Officer. The question is on agreeing to the conference
report.

739

Mr. Allex. I call for the yeas and nays, Mr. President.
The Presidixg Officer.* Is there a* sufficient se<^ond ? There is a
sufficient second.

The yeas and nays were ordered.

The Presiwxg Officer. The question is on agreeing to the conference
report. On this question, the yeas and nays have been ordered, and the
clerk will call the roll.

The legislative clerk called the roll.

Mr. Robert C. Byrd. I announce that the Senator from Texas
(Mr. Bentsen), the Senator from Nevada (Mr. Cannon), the Senator
from Florida (Mr. Chiles), the Senator from Michigan (Mr. Philip
A. Hart), the Senator from Minnesota (Mr. Humphrey), the Senator
from Wyoming (Mr. ]McGee). the Senator from Minnesota (Mr. Mon-
dale) , the Senator from Xew Mexico (Mr. Montoya) , the Senator from
Georgia (Mr. Talmadge). and the Senator from Calif ornia (Mr. Tun-
nev) are necessarily absent.

I further announce that the Senator from Ohio (Mr. Glenn), the
Senator from Montana (Mr. Mansfield), and the Senator from South
Dakota (Mr. McGovern) are absent on official business.

I further announce that, if present and voting, the Senator from
Minnesota (Mr. Humphrey) would vote "yea."'

Mr. Griffix. T announce that the Senator from Maryland
(Mr. Beall), the Senator from Xew York (Mr. Buckley), the Senator
from Nebraska (Mr. Curtis), the Senator from Kansas (Mr. Dole),
the Senator from Arizona (Mr. Goldwater), the Senator from Wy-
oming (Mr. Hansen), the Senator from Xew York (Mr. Javits), and
the Senator from Oregon (Mr. Packwood) are necessarily absent.

I further announce that, if present and voting, the Senator from
Maryland (Mr. Beall) would vote "yea.''

The result was announced — yeas 73. nays 6, as follows:

[Rollcall Vote No. 656 Leg.]

YEAS— 73

Abourezk

Allen

Baker

Bayh

Bellmon

Biden

Brock

Brooke

Bumpers

Biirdick

Byrd, Harry F., Jr.

Byrd, Robert C.

Case

Church

Clark

Cranston

Culver

Domenici

Durkin

Eagleton

Eastland

Fong

Ford

Garn

Gravel

Griffin

Hart, Gary

Hartke

Haskell

Hatfield

Hathaway

HoUings

Hruska

Huddleston

Inouye

Jackson

.Johnston

Kennedy

Laxalt

Leahy

Long

Magnuson

Mathias

McClellan

Mclntyre

Metcalf

Morgan

Moss

Muskie

Nelson

Nunn

Pastore

Pearson

Pell

Percy

Proxmire

Randolph

Ribicoff

Roth

Schweiker

Scott, Hugh

Sparkman

Stafford

Stennis

Stevens

Stevenson

Stone

Symington

Taft

Thurmond
Weicker
Williams
Young

740

NAYS— 6

Bartlett
Fannin

Helms
McClure

Scott, William L.
Tower

NOT VOTING— 21

Beall
Bentsen
Buckley

Glenn

Goldwater

Hansen

Hart, Philip A.
Humphrey
Javits
Mansfield

McGovern

Mondale

Montoya

Packwood

Talmadge

Tunney

McGee

Cannon
Chiles
Curtis
Dole

So the conference report was agreed to.

Mr. Magnuson. Mr. President, I move to reconsider the vote by
which the conference report was agreed to.

Mr. IxouYE. I move to lay that motion on the table.
The motion to lay on the table was agreed to.

[Subsequently, on 1 October 1976, Senator Magnuson made the fol-
lowing comments concerning S. 3149 as reported from conference and
passed by the Senate :]

Mr. Magnuson. Mr. President, on Tuesday, September 28, both the
House and the Senate approved the conference report onn S. 3149, the
Toxic Substances Control Act. That act is now before the President.

One of the key provisions of the act concerns the premarket notifica-
tion procedures of section 5. They are extremely important as they
form the basis by which threats to health or the environment will be-
come known and responded to prior to first manufacture df a new
chemical substance or manufacture or processing of an existing sub-
stance for a significant new use. Apparently, some confusion still exists
over the meaning of the conference report with respect to the responsi-
bility of manufacturers or processors to submit notice of proposed
manufacture or processing of new substances or significant new uses
of existing substances and the notice of objections that a manufacturer
or processor may file with the Administrator after the Administrator
has issued a proposed order to halt or limit the substance.

With respect to the first point, it has been stated that the 90-day pre-
market notification provision begins running when EPA receives notice
from the manufacturer, regardless of whether or not the information
submitted is in conformance with the requirements of the statute. This
is clearly not so. Section 5 (d) of the statute explicity states that the
notice must include certain specific information. This includes the
name, identity, and molecular structure of the chemical; proposed
categories of use ; amount to be manufactured or processed ; a descrip-
tion of byproducts ; the number of individuals exposed ; and the man-
ner or method of its disposal. In addition, any test data in possession or
control of the person is to be submitted, in such form and manner as
the Administrator prescribes and a description of any other data con-
cerning the environmental and health effects of the substance.

The requirements of the act are clear. If this information is not
properly submitted, then the notification requirements of the act liaye
not been complied with. Manufacture or processing mav not begin
until 90 days — or 180 days, if extended — after proper notification has
been given.

741

In addition, there seems to be some misunderstanding on the manner
in which a proposed order of the Administrator to prohibit or limit
manufacture of a substance during the notification period could be
rendered ineffective by the filing of objections by the manufacturer or
processor. The act states explicitly that the objections must specify
"with particularity the provisions of the order deemed objectionable
and stating the grounds therefor [Sec. 5(e)(1)(C)]." Any objection
not meeting these requirements will not be considered as filed. More-
over, as the entire procedure is borrowed from section 701(e) of the
Federal Food, Drug, and Cosmetic Act, the interpretation of this pro-
vision is the same as it is under that provision. In fact, the statement
of managers accompanying S. 3149 states that —

The conference substitutes borrows the procedure from section 701(e) of the
Federal Food, Drug, and Cosmetic Act.

As was stated on the Senate floor when the conference report was
approved on September 28, the case law developed pursuant to section
701(e) of the Federal Food, Drug, and Cosmetic Act applies to the
procedure under this act as well. That case law — Pfizer v. Richardson^
C.A. 2, 1970, 434 F. 2d 536— as applied to this act, authorizes the
Administrator to require that reasonable grounds be stated by a manu-
facturer or processor as a condition for recognizing that objections
have been filed. Thus, the Administrator will determine whether or not
objections have l>een field on the l>asis of whether or not the objections
conform with the requirements of the statute, as interpreted under the
case law developed pursuant to section 701(e) of the Federal Food,
Drug, and Cosmetic Act.

Mr. President, it is my hope that this explanation will clear up any
misunderstanding that might have occurred on the requirements of the
section.

HOrSE CONSIDERATIOX OF CONFERENCE REPORT

[Excerpt from the Congres'slonal Record, Sept. 28, 1976, House, pp. H11343-H11347]

CoxFERExcE Report OX S. 3149, Toxic Substances Control Act

Mr. MrRPiiY of New York. Mr. Speaker, I call up the conference re-
port on the Senate bill (S. 3149) to regulate commerce and protect
human health and the environment by requiring testing and necessary
use restrictions on certain chemical substances, and for other purposes,
and ask unanimous consent that the statement of the managers be read
in lieu of the report.

The Clerk read the title of the bill.

The Speaker pro tempore. Is there objection to the request of the
Cfentleman from Ohio?
There was no objection.

Mr. Staggers. IVIr. Speaker, the Toxic Substances Control Act is leg-
islation which first passed the Senate in March 1976 and then passed
the House on August 23. 1976 by a vote of 319 to 45. The House lan-
ofuage differed from that of the'Senate and a conference was needed.
The conferees have met and filed their report.

The conference report essentially preserves the structure of the
House provisions. I will summarize very briefly the resolution of the
differences between the two versions.

742

First, the EPA Administrator is authorized to act against chemical
substances or mixtures which present an unreasonable risk of human
health or the environment.

Second, if there is inadequate information to evaluate the health or
environment effects of a new chemical substance the EPA Adminis-
trator can ask for an immediately effective order before the end of the
premarket notification period to halt or limit its manufacture. The
manufacturer can then file objections to the administrative order with
EPA. If the Administrator does not agree with the manufacturer, he
is authorized to seek a court injunction to halt or limit the manufacture
of the new chemical substance pending the receipt of adequate infor-
mation on the new chemical substance [Sec. 6].

Third, the proAdsions in the House version protectinjs: the small
chemical manufacturer from burdensome reporting and filing fee re-
quirements are retained [Sec. 8].

Fourth, the language of the House version is retained regarding the
Administrator's authority to use the Toxic Substances Control Act as
opposed to other existing Federal laws, and the Administrator's deci-
sion is committed to his decision [Sec. 9].

Fifth, the following sums are authorized to be appropriated [Sec.
29].

[In millions]

Fiscal year IWIl $10. 1

Fiscal year 1978 12.6

Fiscal year 1979 16.2

Sixth, the effective date is January 1, 1977 [Sec. 31].

Mr. Speaker, we fully expect this legislation to be signed by the
President. This is a good conference report and I urge its enactment.

Mr. Broyhill. Mr. Speaker, the toxic substances control legislation
gives the Administrator of the Environmental Protection Agency
extensive and wide-ranging authorities to regulate all aspects of the
chemical industry. Briefly stated, this legislation would authorize the
Environmental Protection Agency to require that manufacturers of
chemical substances perform testing, would require that manufactur-
ers of new chemical substances or existing substances being put to sig-
nificant new uses provide EPA with certain information 90 days prior
to manufacture, and would authorize EPA to impose various kinds of
regulations on substances which the Administrator has found pose an
unreasonable risk to health or the environment. The general standard
for taking action under the legislation is that the substance may pre-
sent an unreasonable risk. The conferees intend to limit the Admin-
istrator to taking action onlv against unreasonable risks because to do
otherwise assumes that a risk-free society is attainable, an assump-
tion that Conjrress does not make.

Although the authorities granted to EPA are extremely broad, the
conferees have made a concerted effort to include in the conference re-
port safeguards acrainst arbitrary action on the part of EPA. As is
stated in section 2 of the conference substitute, the conferees intend
that the Administrator of the Environmental Protection Agency carry
out this lesrislation in a reasonable fashion, taking into consideration
pot only the environmental effects, but also the economic and societal
impact of its regulatory actions. As section 2(c) makes clear, action

743

should be taken in an informed and responsible manner based upon
knowledge, information and facts. To do less is to act in an irrespon-
sible, imprudent and overly cautious manner. Further, any legislation
falls more heavily on this country's small business community and the
conferees expect that the Administrator of the EPA will consider the
impact which his actions may have on the small businesses regulated
under this legislation.

One of the most far-reaching and controversial provisions of the
legislation is section 5 setting out the premarket notification require-
ments for manufacturers and processors of new chemical substances
and of existing chemical substances which are being put to signifi-
cant new uses. This section requires that those manufacturers and
processors submit information specified in the legislation to EPA
at least 90 days prior to manufacture. This 90-day period may be
extended for an additional 90 days for good cause. If the informa-
tion available about a substance is inadequate, the Administrator may
issue a proposed order to prohibit or limit production of the substance
to go into effect upon the expiration of the premarket notification
period. The proposed order would have to be issued at least 45 days
prior to the expiration of the premarket notification period. If the
manufacturer or processor of a substance files objections to the pro-
posed order, or if the notice period w^ill expire in less than 45 days,
tlie Administrator may seek a court injunction to prohibit or limit
the manufacture of the substance. The procedure I have just described
would also be available to the Administrator if he had adequate
information about the substance indicating that it poses an imminent
hazard and he wishes to ban the particular substance.

The legislation states that a manufacturer or processor may file
objections with the Administrator "specifying with particularity the
provisions of the order deemed objectionable." The purpose of this
provision is to put the Administrator on notice as to the objections
of the manufacturer or processor. However, the Administrator could
not put the proposed order into effect because he determined that the
objections of the manufacturer were either unmeritorious or not of
sufficient S])ecificity. It is enough that the Administrator be on notice
that objections do lie against the proposed order. Similarly, with
respect to the 90-day premarket notice provision, this period would
begin runninof when EPA receives the notice and information speci-
fied in the bill. EPA could not stop the tolling of the period by alleg-
ing that the information submitted by the manufacturer or processor
was incomplete.

In section 6 of the conference substitute, we have given the Admin-
istrator authority to promulgate a number of different kinds of regu-
lations ranging from the total ban of a substance to requirement that
a substance be marked wtih warnings or instructions with respect
to its use or disposal. However, I wish to emphasize that the conferees
intend that the Administrator impose the least burdensome require-
ments necessary to adequately protect against the risk.

The conference substitute' includes a provision regulating PCB's
similar to the provision included in the House bill [Sec. 6(e)]. This
provision sets out a timetable for regulating PCB's culminating in at
ban on the processing or distribution in commerce of PCB's 21/^ years

744

after the effective date of this act. The purpose of this ban is to pre-
clude the manufacture, processing or distribution in commerce of new
PCB's or new equipment containing PCB's in 21/2 years after the
effective date of this act. It should be noted, however, that equipment
now in existence containing PCB's is clearly exempted from this ban.
Similarly, any PCB substance in existence would also be exempted
from the ban on processing and distributing in commerce if sold or
used to maintain existing equipment or transported for purposes of
disposal.

]\Ir. Speaker, the conference report now before us vests awesome,
new responsibilities in the Environmental Protection Agency. How-
ever, I am confident that if the legislation is regulated in a prudent
and reasonable manner, as the conferees intend, it will not prove to be
overly burdensome to those regulated by it. Therefore, I support the
passage of this conference report.

^Ir. Skubitz. Mr. Speaker, yesterday the House passed the Re-
sources Conservation and Recovery Act, which sets out a detailed
plan for regulating the disposal of hazardous wastes. I note, however,
that section 6 of the toxic substances conference report gives the
Administrator of the Environmental Protection Agency authority to
promulgate regulations with respect to the manner or method of
disposal of toxic substances. I am concerned that we may be setting
up two different regulatory schemes to regulate the same kinds of
substances. Would the gentleman from North Carolina care to com-
ment no that ?

Mr. Broyhill. Mr. Speaker, I will be glad to comment on that.
Perhaps the gentleman from West Virginia also w^ould want com-
ment on this.

Of course, I share the gentleman's concern about this. It is my
understanding of what the conferees intend here is that, in this par-
ticular case, EPA would use the authorities that are granted to it in
the Resource Conservation and Recovery Act. If those authorities can
be used to regulate the potential problem, then we would expect those
authorities would be used, rather than immediately going to the
provisions of the Toxic Substances Act. I believe that section 9 of the
conference report would require this result since it w^as the intent
of the conferees that the Toxic Substances Act not be used, when
another act is sufficient to regulate a particular risk.

Mr. Skubitz. I thank the gentleman.

Mr. Broytiill. The Administrator of EPA is to use authorities in the
Toxic Substances Act if he cannot regulate potential hazards under
other acts.

Mr. Skubitz. I thank the gentleman.

Mr. Staggers. I would agree with the statement of the gentleman
from Xorth Carolina that this is the intention of the conferees. Section
9(b) of the conference report states that if the Administrator deter-
mines that a risk to health or the environment associated with a chem-
ical substance or mixture could be reduced to a sufficient extent by act-
ing under other EPA-administered laws, the Administrator must use
those other laws unless he determines, in his discretion, that it is in the
public interest to protect against the risk by using the Toxic Substances

745

Control Act. Therefore, I would agree completely with the answer the
gentleman from North Carolina gave the gentleman from Kansas.

Mr. Moore. Mr. Speaker, Members of the House, I am very disap-
pointed in this conference report for several reasons, but the most im-
portant one is that on August 23, 1976, when we considered this bill,
T offered an amendment [Sec. 32 of H.R. 14032 as passed by the House]
which the House passed by a recorded vote of 210 to 157. At that time,
that was the ninth instance the House had passed such an amendment.
We know it now as the legislative veto amendment, wherein either
House is given 60 legislative days to veto a regulation of an administra-
tive agency ; in this particular case, the agency having administrative
jurisdiction of this bill.

Since that time, an additional and tenth time, the House passed such
an amendment. Again, I offered it, and then even more recently, just
a week ago, the House considered under suspension a bill which would
have made this veto blanket law. That bill passed clearly by a majority,
and failed by only six votes of having a two-thirds majority of this
House voting for this legislative veto as a necessary curb of the
bureaucracy.

In every instance, we passed this amendment save one. the House
conferees have crate red or give it up in conference. I think it is high
time that we stop playing games with the public and stop playing
games with the poor freshmen like myself, allowing us to pass these
amendments, going to the public and saying, "We are making these
reforms," and then going into the conference committee and cratering,
letting them strip them off with no real attempt to liold them.

That is not the intent on the House floor. We voted on this amend-
ment. We have thwarted the clear, distinct, overwhelming will of the
House by stripping that amendment off. I do not know what it takes
to have certain Members of this House understand what the will of the
House is, but it certainly has been thwarted in this particular instance.

I would offer a motion to recommit this conference report v.ith in-
structions to reinsert that amendment if it were possible, but this being
the second House to consider the conference report, it is not possible.
Therefore, it seems to me that Members — some 265 by the last count —
who believe that we need this kind of reform, ought to consider voting
this conference report down. It would be an even clearer message, evi-
dently, of what we have been saying that we are serious about this
bureaucratic reform, and expect amendments like these passed by the
House and to be held to by the House conferees when the bill goes to
conference.

Mr. Levitas. Mr. Speaker, I would like to associate myself with the
remarks of the gentleman from Louisiana. I am very disappointed that
this congressional veto provision that was in the House bill was taken
out of the bill by the conference committee. What disturbs me even
more is the fact, according to information I have received, that the
managers on the part of the House did not fight for the House posi-
tion in this matter ; did not stand up for the expressed will of the House,
but went into that conference committee with the understanding that
they would cave in as soon as challenged. Indeed one proponent of this
bill who opposed the congressional veto amendment when it was offered

79-313 O - 77 - 48

746

in the Honse said that it would be stripped off in conference and he
later serA^ed on the conference committee. His prediction came true.

I think that this type of action is flying in the face of everything that
this process stands for. The openly and freely expressed will of the
majority should be respected.

It is interesting. I look at the ^Members of the House who are man-
agers on the part of the House, and some of them are in the forefront
of the leadership reform in the House. They speak of reform. But they
act otherwise. I think one of the reforms we ought to institute is to
have the managers on the part of the House stand up for the House
when they get into a conference committee. I think it is time to say,
"Reformer, heal thyself because they ought to stand up for the ex-
pressed will of the House or else the democratic process is perverted.

There were 265 Members of this House who went on record in favor
of the congressional veto by voting for H.R. 12048 just last week. An
opportunity to carry out that will was lost by our conferees. They are
supposed to represent our position and the position of the American
people, but they cave in and surrender. I think we ought to change that.
If we do not do it today, it certainly ought to be the highest order of
priority in the next Congress.

Mr. Broyiiill. Mr. Speaker, I support the concept upon which the
amendment to which the Members refer is based. Unfortunately, the
Senate would not go along with us on that.

Mr. Speaker, I would point out to the gentleman from Georgia and
also to the gentleman from Louisiana that there is a good chance that
a similar amendment offered by the gentleman from Louisiana to the
Clean Air Act may be left in that act. So perhaps we are making some
progress.

Mr. Murphy of New York. Mr. Speaker, the conference report before
us today is one of the most important pieces of legislation to be consid-
ered by the Congress this year. It is legislation designed to protect our
people and our environment from harmful chemical substances. It is
the culmination of a legislative effort that spans three Congresses, and
as recent incidents have indicated the legislation comes none too soon.
The legislation is supported by such diverse groups as the National
March of Dimes, the Manufacturing Chemists Association, the United
Steelworkers, the Sierra Club, and the AFL-CIO.

Chemical substances have become an enduring part of our environ-
ment. They are in our air, our water, and our soil. They are used in our
manufacturing processes and they are essential components for con-
sumer and industrial goods. While society reaps enormous benefits from
chemicals, we are learning that chemicals can also do tremendous harm.
For example, contamination by polychlorinated biphenyls — PCB's —
has resulted in closing some of our major water systems to fishing. Re-
cent studies have linked this highly persistent, environmental poison to
human cancer, and we are now discovering troublesome levels of PCB's
in mother's milk. Thousands of cattle have had to be killed in Michigan
because of contamination by polybrominated biphenyls — PBB's. As-
bestos, widely used in items ranging from talcum powder to brake
linings to wallboard is now known to cause cancer and other debilitat-
ing illnesses. These examples make it quite clear that the country faces
serious risk of harm to the health of its people and to its environment
from the substantial use which is made of chemicals. Unfortunately,

747

current Federal law is inadequate to deal witli the risks presented by
these substances. The legislation before us today will enable us to act
to protect health and the environment from the pernicious effects of
toxic chemicals.

Tlie bill before us today is substantially similar to that which passed
the House by a wide margin on August 23. Briefly, the bill will ; First,
require manufacturers and processors of potentially harmful chemical
substances and mixtures to test their products so that their effects on
health and the environment may be evaluated; second, require manu-
facturers of new chemical substances for significant new uses to notify
the EPA 90 days in advance of commercial production ; third, author-
ize delays or restrictions on the manufacture of new chemical sub-
stances which have been inadequately tested and which may be danger-
ous; fourth, authorize the EPA to adopt rules to prohibit or limit the
manufacture, processing, distribution, use or disposal of chemical sub-
stances or mixtures which present an unreasonable risk to health or
the environment ; fifth, authorize the Administrator to take immediate
action to protect the public and the environment from an imminently
hazardous chemical substance or mixture; and sixth, ban the manufac-
ture, processing, and use of PCB's within 21^2 years.

The overriding purpose of the legislation is to provide protection of
health and the environment through authorities which are designed to
prevent chemical harm l>efore it occurs, rather than merely reacting to
harm after it has occurred. In addition, the legislation is designed to
improve our abilities for dealing with hazardous chemicals after the
harm has been manifested.

The legislation achieves these objectives through three major provi-
sions. First, under the bill the Administrator of the Environmental
Protection Agency is instructed to require manufacturers and proces-
sors to conduct testing on their chemical substances or mixtures if cer-
tain factors exist [Sec. 4].

Testing will be required in instances in which there is inadequate in-
formation to evaluate the health and environmental effects of the sub-
stance or mixture and when testing is necessary to develop data re-
specting the health or environmental effects. In addition, there must be
some basis for concern about the substance. If there is information iiidi-
cating that the substance or mixture may present an unreasonable risk
to liealth or the environment, testing is required. For example, if one
substance is- structurally similar to a second chemical with known ad-
verse health or environmental effects, the Admhiistrator could reason-
ably conclude that the first chemical may present an unreasonable risk
and therefore recpiire testing of it to determine its health and environ-
mental effects. Or if there is reliable preliminary data indicating that
a substance may be dangerous, again it would be reasonable to conclude
that the chemical may present an unreasonable risk and that additional
testing should be done. In addition, testing can be required in certain
situations even though there is an absence of any information indicat-
ing that the substance or mixture per se may be harmful. This occurs
when there is or will be substantial j^roduction coupled with substantial
envii'onmental or substantial or significant human exposure to a sub-
stance or mixture about which there is inadequate information. Thus,
the legislation recognizes the importance in seeing that chemicals to

748

which there is substantial human or environmental exposure be ade-
quately tested to see that they are safe.

In the case of mixtures, the legislation encourages the Administra-
tor to first look at the substances which comprise the mixture to
determine whether the mixture's health and environmental effects may
not be reasonably and more efficiently determined or predicted by
testing the subvStances comprising the mixtures rather than the entire
mixture. This is intended to reduce unnecessary or duplicative test-
ing, since the assessment of safety of a mixture may well be based on
the toxicity of particular components, and tests of the entire mix-
ture with its varying component ratios may be unnecessary or
unrewarding.

The testing authorities in the bill will enable us to find out about
the chemical substances and mixtures which are already out in the
envii'Oi nient as well as those which are just coming on to the market.

The oecond major regulatory provision which will enable us to
protect against the occurrence of chemical harm is the premarket
notification provisions of the legislation [Sec. 5]. Under the bill,
manufacturers or new chemical substances and manufacturers and
processors of existing chemical substances for significant new uses
must ^^ive EPA 90 days' notice before commercial production begins.
Because the conference report adopts the House definition of "chem-
ical su bstance,'' the Administrator will receive advance notice not only
of new synthetic chemicals, but also of naturally occurring substances
which are produced or manufactured commercially for the first time.
The notification requirements are intended to provide the Admin-
istrator with an o])portunity to review and evaluate information with
respect to the substance to determine if manufacture, processing, dis-
tribution in commerce, use or disposal should be limited, delayed, or
prohibited because data is insufficient to evaluate the health and envi-
ronmental effects or because the substance or the new use presents
or will present an unreasonable risk of injury to health or the
environment.

Because the damage Avhich can be done by a chemical substance or
mixture is oftentimes irreparable, our experience indicates that the
most desirable time to determine the health and environmental effects
of a substance, and to take action to protect against any potential
adverse efl'ects, occurs before there is human or environmental ex-
posure to the substance. This is the only practical means of avoiding
human and environmental harm. In addition, the cost of any regula-
tory action in terms of loss of jobs and capital investment is
minimized.

In addition to the testing and the notification requirements of the
bill, the lej2:islation empowers and directs the Administrator of EPA
to take action to protect the public and the environment from chemical
substances and mixtures which present an unreasonable risk of injury
[Sec. 6]. If there is a rensonable basis to conclude that the manu-
facture, processino;, distribution in commerce, use or disposal of a
substance or mixture presents an unreasonable risk, then the Admin-
istrator is to take regulatory action necessary to adequatelv ]^rotect
against the risk. The Administrator can prohibit or limit the manu-
facture, processing, distribution, use or disposal of the substance or
any combination of these requirements. To impose one of these require-

749

ments, the Administrator must go through a rulemaking proceeding
which allows all interested persons an opportunity for a hearing, and
in certain instances an opportunity for cross-examination is also pro-
vided. However, if there is an imminent threat to health or the envi-
ronment, tlie bill contains authority which allows the Administrator
to take immediate action to ])rotect health or the environment.

In addition to these major authorities, the conference report con-
tains recordkeeping and reporting authority, and inspection authority
necessary for EPA to adequately administer the act. It also assures
adequate citizen participation through provisions authorizing citizen
suits and petitions. The conference report also provides for protection
for employees wlio cooperate in the administration and enforcement
of the act.

The bill also delineates the relationship between the Federal Gov-
ernment and State or political subdivisions in regulating chemical
substances or mixtures. Generally the legislation provides that nothing
in the bill shall effect the authority of a State or political subdivision
to establish or continue in effect regulation of a chemical substance
or mixture or article containing a substance or mixture. However,
State and local regulation is preempted in certain instances. For ex-
ample, if the Administrator establishes a testing rule under section 4,
no State or local government may establish or continue in effect a test-
ing rule for purposes similar to those for which the testing is required
under section 4. Xor may any State regulate any risk associated with
a substance or mixture if the Administrator has prescribed a rule or
order under sections 5 or 6 which is designed to protect against the
risk unless the State or local requirement is one identical to that
issued under this act, is adopted under the authority of another
Federal law, or prohibits the use of the substance or mixture other
than its use in the manufacture or processing of other chemical sub-
stances or iiiixtures. This last exemption from the preemptive effect
of a Federal regulation recognizes the interest of the State in ade-
qmitely ])rotecting its citizens and its environment from hannful
chemicals while at the same time protecting the interest of interstate
commerce in chemical substances and mixtures. The purpose of the
pi-ovision is to enable States to totally ban a specific end use of a
substance or mixture while not interfering with the manufacture
or processing and distribution of substances or mixtures. For in-
stances, a State could totally prohibit the use within its boundaries of
n detergent containincf a particular chemical substance. However, the
State could not prohibit the manufacture or processing within the
State of either the substance or the detergent, nor could it prohibit
oi- limit interstate distribution of the substance.

The conference lepoi-t retains many of the provisions in the House
legislation designed to protect small business. These include partial
exemptions from the general i-eporting provisions of the bill, estab-
lishment of a special office which will help small manufacturers under-
stand the provisions of the bill, a requirement that the economic effects
on small businesses be considered by the Administrator in taking
regulatory action under section 6, and a maximum of $100 for filing
fees.

Mr. S])eaker, the conference report will enable us to begin the very
important task of protecting the public and the environment from

750

harmful chemical substances and mixtures. It is legislation which is
long overdue, and I urge my colleagues to approve the conference
report.

Mr. Staggers. Mr. Speaker, I feel a little bit as I did when I first
came to Congress and was on the Veterans' Committee. We held some
hearings on one of the fii-st bills that came to the floor on veterans'
benefits. I thought the bill was certainly for the best interests of the
veterans of this land, having been a disabled veteran in World War
II, and having voted every time for every veterans' benefit that came
on the floor.

Two gentlemeji came to the well and said that this was not done
and that was not done, and all I did was to say, "Were you there
when we discussed this in committee?" Both of them said they were
not. I said, "You do not have a right to judge what was done."

I say to the gentleman from Ix)uisiana and to the gentleman from
Georgia, who are fine gentleuien, who represent their districts well,
and are, as I say, gentlemen in every sense of the word, that in con-
ference we did try to uphold what was in the best interests of the
House. I have always tried to do that. I have never gone to a confer-
ence with my mind made up that I am going to give in on anything
the House has done.

The Senate did not have a similar provision in their bill, and they
said, "We will not have it in the conference report." They said not
only that, but that a bill was vetoed recently that had such a provision,
the pesticides legislation. The President gave that as his reason for
vetoin/nr that bill. That is one of the reasons that it did not come back
to the House floor.

Mr. Speaker, I would like to see the provision in the bill. However,
I see reality, too. A^Tien we go to conference we are a coequal branch,
and we have to listen to what the Senate says on their side. There are
points they think are valid; and we think we have points that are
equally as valid. We are in such a situation right now with the Clean
Air Act. The Senate thinks they are going to get their way, and we
think they are wrong. We may not get a bill. If two men come up
against a stone wall and nothing gives, then we do not get a bill. That
is not the wav we make laws in this Congress, nor the way the con-
ference acts. When the House and Senate go to conference, they must
compromise a little bit to try to get legislation approved by both sides.

This conference report passed the Senate this morning by a vote
of 72 to 6. I think it ought to pass this House by the same majority,
because this is the third time the toxic substances legislation has
passed the House of Representatives, and it never has become law.

It is time now that this legislation is enacted, because we know that
many chemical substances present serious risks to health and the
environment in America. Problems of cancer or birth defects are
serious ones. It is time that we remedy this situation. We have the
opportunity as Representatives of the people to let them know we are
trying to protect their health and provide a better environment.

Mr. Speaker. I urge the adoption of the conference report.

Mr. Staggers. Mr. Speaker, I move the previous question on the
conference report.

The previous question was ordered.

The Speaker pro tempore (Mr. McFall). The question is on the
conference report.

751

The question was taken; and the Speaker pro tempore announced
that the ayes appeared to have it.

]Mr. Steigek of Wisconsin. Mr. Speaker, I object to the vote on the
<jround that a quorum is not present and make the point of order
that a quorum is not present.

The Spkakek pro tempore. Evidently a quorum is not present.

The Sergeant at Arms will notify absent Members.

The vote was taken by electronic device, and there were — yeas 360,
nays 35, not voting 35, as follows :

[Roll No. 820]

YEAS— 360

Abdnor

Burlison, Mo.

Abzug

Burton, John

Adams

Burton, Phillip

Addabbo

Butler

Alexander

Byron

Allen

Carney

Ambro

Carr

Anderson, Calif.

Carter

Anderson, 111.

Chappell

Andrews, N.C.

Chisholm

Andrews, N. Dak.

Clancy

Annunzio

Clausen, Don H.

Aspin

Clay

AuCoin

Cleveland

Bafalis

Cochran

Baldus

Cohen

Baiiman

Collins, 111.

Beard, Tenn.

Conable

Bedell

Conte

Bell

Conyers

Bennett

Corman

Berjrland

Cornell

Bevill

Cotter

Biaggi

Coughlin

Blester

D' Amours

Bingham

Daniel, Dan

Blanchard

Daniel, R. W.

Blouin

Daniels, X.J.

Boggs

Danielson

Boland

Delaney

Boiling

Dellums

Bonker

Dent

Bowen

Derrick

Brademas

Derwinski

Breaux

Devine

Breckinridge

Dickinson

Brinkley

Dlggs

Brodhead

Dingell

Brooks

Dodd

Broomfield

Downey, N.Y.

Brown, Calif.

Downing, Va.

Brown, Mich.

Drinan

Brown. Ohio

Duncan, Oreg.

Broyhill

Duncan, Tenn.

Buchanan

du Pont

Burgener

Early

Burke, Calif.

Eckhardt

Burke, Fla.

Edgar

Burke, Mass.

Edwards, Ala.

Edwards, Calif.

Eilberg

Emery

Erlenbom

Eshleman

Evans, Colo.

Evins, Tenn.

Fary

Fascell

Fenwick

Findley

Fish

Fisher

Fithian

Flood

Florio

Flowers

Foley

Ford, Mich.

Ford, Tenn.

Forsythe

Fountain

Eraser

Frenzel

Frey

Fuqua

Gaydos

Giaimo

Gibbons

Gil man

Ginn

Goldwater

Gonzalez

Goodling

Gradison

Gude

Guyer

Hagedorn

Haley

Hall, 111.

Hamilton

Hanley

Hannaford

Harkin

Harrington

Harris

Harsha

Hechler, W. Va.
Heckler, Mass.

752

Hefner

Helstoski

Henderson

Hicks

Hightowei*

Hillis

Holt

Holtzman

Horton

Howard

Howe

Hubbard

Hughes

Hungate

Hyde

Jacobs

Jeffords

Johnson, Calif.

Johnson, Colo.

Johnson, Pa.

Jones, Ala.

Jones, N.C.

Jones, Okla.

Jones, Tenn.

Jordan

Karth

Kasten

Kastenmeier

Kazen

Kemp

Kindness

Koch

Krebs

Krueger

LaFalce

Lagomarsino

Landrum

Latta

Leggett

Lehman

Lent

Levitas

Lloyd, Calif.

Lloyd, Tenn.

Long, La.

Long, Md.

Lott

Lujan

Lundine

McClory

McCloskey

McCormack

McFall

McHugh

McKay

McKinney

Madden

Madigan

Maguire

Mahon

Mann

Martin

Mathis

Mazzoli

Meeds

Melcher

Metcalfe

Meyner

Mezvinsky

Michel

Mikva

Milford

Miller, Calif.

Miller, Ohio

Mills

Mineta

Minish

Mitchell, Md.

Mitchell, N.Y.

Moakley

Moffett

Mollohan

Moorhead, Calif.

Moorhead, Pa.

Morgan

Mosher

Mottl

Murphy, 111.

Murphy, N.Y.

Murtha

Myers, Ind.

Myers, Pa.

Natcher

Neal

Nedzi

Nichols

Nolan

Nowak

Oberstar

Obey

O'Brien

O'Hara

O'Neill

Ottinger

Patten, N.J.

Patterson, Calif.

Pattison, N.Y.

Perkins

Pettis

Peyser

Pickle

Pike

Poage

Pressler

Preyer

Price

Pritchard

Quie

Quillen

Railsback

Randall

Rangel

Rees

Regula

Reuss

Rhodes

Richmond

Rinaldo

Roberts

Robinson

Rodino

Roe

Rogers

Roncalio

Rooney

Rose

Rosenthal

Rostenkowski

Roush

Roybal

Ruppe

Russo

Ryan

St Germain

Santini

Sarasin

Sarbanes

Satterfield

Schneebeli

Schroeder

Schulze

Seiberling

Sharp

Shipley

Shriver

Sikes

Simon

Sisk

Skubitz

Slack

Smith, Iowa

Smith, Nebr.

Snyder

Solarz

Spellman

Staggers

Stanton, J. WilliaD
Stanton, James V.
Stark
Steed

Steiger, Wis.

Stephens

Stokes

Stratton

Studds

Sullivan

Symington

Talcott

Taylor, N.C.

Thone

Thornton

Traxler

Treen

Tsongas

Udall

UUman

Van Deerlin

Vander Veen

Vanik

Vigorito

Walsh

Waxman

753

Weaver

Whalen

White

Whitehurst

Whitten

Wiffsrins

Wilson, Bob

Archer

Armstrong

Ashbrook

Burleson. Tex.

Cederberg

Clawsou. Del.

Collins. Tex.

Crane

Davis

de la Garza

English

Evans, Ind.

Ashley

Badillo

Baucus

Beard. R.I.

Conlan

Esch

Flynt

Green

Hawkins

Hayes. Ind.

Hubert

Heinz

Winn

Wirth

Wolfe

Wright

Wydler

Wylie

Yates

NAYS 35

Grassley

Hall. Tex.

Hammersehmidt

Hansen

Hutchinson

Ichord

Jenrette

Kelly

Ketchum

McDonald

Montgomery

Moore

NOT VOTING— 35

Hinshaw
Holland
Jarman
Keys

McCoUister

McDade

McEwen

Matsunaga

Mink

Moss

Nix

Passman

Yatron

Young. Alaska
Young, Fla.
Young, Ga.
Young, Tex.
Zablocki
Zeferetti

Paul

Risenhoover

Rousselot

Runnels

Sebelius

Shuster

Spence

Symms

Taylor. Mo.

Vander Jagt

Waggonner

Pepper

Riegle

Scheuer

Steelmau

Steisrer, Ariz.

Stuckey

Teague

Thompson

Wampler

Wilson. C. H.

Wilson, Tex.

Mr. Abdnor, changed his vote from '*iiay"' to ''yea.''
So the conference report was agreed to.
The result of the vote was announced as above recorded.
A motion to reconsider was laid on tlie table.

[Subsequently, on October 1, 1976, Congressman Murphy of Xew
York made the following comments concerning S. 3149 as reported
from conference and passed by the House :]

Mr. Mi'RPHY of Xew York. Mr. Speaker, I should like to say a few
words about the intent of the conferees on a matter not made explicit
in the Conference Report on the Toxic Substances Control Act. The
conferees recognize that the requirements prescribed by the Adminis-
trator under section 6(a) of the Toxic Substances Control Act may
provide protection for employees in the workplace. For example, by
prohibiting the manufacture of a substance, risks to employees in-
volved in the manufacturing of the substance would be eliminated.
Or by requiring a manufacturer of a hazardous chemical or an article
containing such a chemical to provide warning labels regarding use,
persons using the substance or article in the workplace will be alerted
to any potential risks. However, the conferees do not intend to vest in
the Administrator authority to issue workplace standards directly reg-
ulating such matters as the airlx)rne concentrations of a substance to

754

which employees may be exposed or issue rules regarding personal pro-
tective equipment for employees, or work practices in operations haz-
ardous to employees. Such direct regulation of the workplace falls
under the jurisdiction of the Occupational Safety and Health Act,
not under this bill. Of course, if the manner in which a substance is
handled in the workplace presents a risk, not to the worker, but to the
public or to the environment, the Administrator could use the authori-
ties in the Toxic Substances Control Act to protect against that risk.

APPENDIX I

COUNCIL ON ENVIRONMENTAL QUALITY REPORT—
TOXIC SUBSTANCES (1971)

TOXIC
SUBSTANCES

Prepared

by the Council on Environmental Quality
April 1971

(757)

Preface

758

In the spring of 1970, shortly after the Council
on Environmental Quality came into being,
we turned to the question of metals and syn-
thetic organic chemicals which might endanger
human health and the environment. It seemed
that new controls were probably necessary to
deal with the problems raised by such sub-
stances, but the scope of the problem, the lack
of a central source of knowledge to deal with
questions raised, and the great uncertainty about
a number of key aspects of the whole area of
toxic substances led us to the conclusion that
extensive staff work would be necessary prior
to a decision about the desirability or content
of possible legislation. This report is the result
of that work.

The data collection, analysis, and much of
the writing of the report were substantially
complete by December 1970. However, the proc-
ess of formulating the President's legislative

program overtook the task of finishing the re-
port. Thus the proposed Toxic Substances Con-
trol Act of 1971 became public before the study
upon which the legislation was based.

The Council is grateful to the many individ-
uals who contributed to preparation of this
study. We are particularly indebted to Dr. John
Buckley and Dr. Edward Burger of the Presi-
dent's Office of Science and Technology, Dr.
Henry Kissman of the National Library of
Medicine, and Dr. Douglas Worf and Dr. Del-
bert Barth of the Environmental Protection
Agency. We hope that this report will help
to shed light on the President's proposed leg-
islation and that it will contribute to under-
standing of a major environmental problem.

Russell E. Train, Chairman

'Robert Cahn

Gordon J. MacDonald

759

Findings and Recommendations

The Council on Environmental Quality has
examined the problems associated with toxic
substances in the environment and has reached
the following conclusions:

Toxic substances are entering
the environment

About 2 million chemical compounds are known,
and several thousand new chemicals are dis-
covered each year. Most new compounds are
laboratory curiosities that will never be pro-
duced commercially. However, several hundred
of these new chemicals are introduced into com-
mercial use annually. Of particular concern be-
cause of their rapidly increasing number and
use are the metals, metallic compounds, and
synthetic organic compounds.

U.S. consumption of metals with known toxic
effects has increased greatly in the last 20 years.
The data on use underestimate the increasing
pervasiveness of metals in our environment be-
cause many new metallic compounds are being
formulated and used in an ever widening
variety of new products.

Similarly, use of synthetic organic chemicals
is growing rapidly. Over 9,000 synthetic com-
pounds are now in commercial use in amounts
of over 1,000 pounds each per year. In 1968, they
totaled nearly 120 billion pounds — a 15 percent
increase over 1967' and a 161 percent increase
over 10 years ago.

Although many of these substances are not
toxic, the sheer number of them, their increas-
ing diversity and use, and the environmental
problems already encountered from some indi-
cate the existence of a problem.

These substances enter man's environment —
and man himself— through complex and inter-
related pathways. "Present in air, water, soil,
consumer products, and food, they pervade our
environment. They often become concentiated
through the food chain — with minute quantities
being magnified thousands of times as they are
consumed by higher forms of life. Increasingly,

all forms of life are being exposed to poten-
tially toxic substances.

These substances can have severe effects

The environmental effects of most of the sub-
stances discussed in this report are not well
understood. Testing has largely been confined
to their acute effects, and knowledge of the
chronic, long-term effects, such as genetic mu-
tation, is inadequate. Although far from com-
plete, available data indicate the potential or
actual danger of a number of these substances.

Many serious effects, including those result-
ing in cancer (carcinogenicity), genetic muta-
tions which cause permanent and transmissible
change in the genes of offspring from those of
the parent (mutagenicity), and production of
physical or biochemical defects in an offspring
(teratogenicity) can occur from metals, their
compounds, and synthetic organic compounds.
In general, we do not know which chemicals
cause such effects or the levels that a given
chemical must reach before the effects occur.

The problem is complicated by the chemical
changes which may occur once toxic substances
enter the en\nronment. They can become more
toxic through modification in the ecosystem or
as a result of synergistic actions with other
substances.

Wildlife and fish populations are also being
exposed to these substances, and some species
have already been severely damaged by such
exposure.

Existing legal authorities are inadequate

Existing Federal Government controls over the
introduction of toxic substances into the envi-
ronment are of two-types. The first is control
over the initial production of a substance and
its distribution. For example, under the Fed-
eral Insecticide, Fungicide, and Rodenticide
Act, a manufacturer must register a pesticide
mth the Environmental Protection Agency

760

(EPA) before it can be introduced in inter-
state commerce. EPA can prohibit distribution
of a pesticide or require labeling of acceptable
uses. This type of control, exercised at the point
of manufacture, is also applied to drugs and
food additives. Although this control technique
can be very effective, current authorities cover
only a small portion of the total number of po-
tentially toxic substances and do not deal with
all uses of a substance which may produce toxic
effects. Most of the substances mentioned in this
report are not subject to the legal controls neces-
sary to protect man from the toxic effects noted.

The second type of control is media oriented
and thus is directed at air and water pollution
from various sources. Federal authority derives
primarily from the Clean Air Act and the Fed-
eral Water Pollution CJontrol Act. Under the
Federal Water Pollution Control Act, the Fed-
eral Government, in cooperation with the
States, sets standards for the amounts of par-
ticular substances allowable in the water. Under
the Clean Air Act, the Federal Government sets
national air quality standards, allowing the
States to set more stringent standards. Enforce-
ment of standards depends on limiting the emis-
sions of a subst^ince from a given source.

In theory, this type of authority can be used
to control the substances discussed in this re-
port, but there are several limitations to the
effective application of such controls. These me-
dia-based authorities are mainly concerned with
pollutants which occur in large quantities. Con-
trolling minute quantities of dangerous sub-
stances is difficult with this type of authority,
in part because of the difficulty of detecting
their presence in air or water. Control is also
difficult because many toxic substances enter
the environment through disposal of consumer
products. If a product is disposed of by flushing
into a municipal sewer line or by burning at an
incinerator, it is almost impossible for the me-
dia-oriented controls to deal effectively with the
toxic decomposition products which might re-

sult. For example, if there were a need to con-
trol a substance contained in a household
detergent, under the media authorities the gov-
ernment could try to limit the amount of the
substance emitted from municipal waste treat-
ment plants. But such a limit would be effective
only if the substance could be removed by exist-
ing treatment methods, and many toxic sub-
stances cannot be so removed.

Most toxic substances are not exclusively air
or water pollutants but can be found in varying
quantities in air. water, soil, food, and indus-
trial and consumer products. The multiplicity of
ways by which man can be exposed to these sub-
stances makes it difficult for the media -oriented
authorities to consider the total exposure of an
individual to a given substance, a considera-
tion necessarj' for the establishment of adequate
environmental standards. Also, in the past no
agency has considered itself completely respon-
sible for all such substances in all media. The
likely result is what happened in the case of
mercury: Available knowledge on adverse ef-
fects was ignored and new data were not
collected.

New legal authority is required

The Council's study indicates the high-priority
need for a program of testing and control of
toxic substances. Our awareness of environ-
mental threats, our ability to screen and test
substances for adverse effects, and our capabil-
ity to monitor and predict, although inadequate,
are sufficiently developed that we need no longer
remain in a purely reactive posture with respect
to toxic substances. We should no longer be lim-
ited to repairing the damage after it has been
done ; nor should we continue to allow the entire
population or the entire environment to be used
as a laboratory.

To assure this protection without handicap-
ping desirable technological innovation or hin-
dering interstate commerce, the Council on En-

761

vironmental Quality recommended new legal
authority.

In February 1971. the President submitted to
the Congress a bill based on these recommenda-
tions. The Toxic Substances Control Act of
1971 calls for several major, new authorities:

• The Administrator of the Environmental Pro-
tection Agency would be empowered to re-
stiict or prohibit the use or distribution of a
chemical substance if such restriction were
necessary to protect health or the environ-
ment. In imposing such a i*ostriction. the Ad-
ministrator would be required to consider not
only the adverse effects of the substance but
also the benefits t^o be derived from its use.

• If the Administrator believed that a substance
were creating an imminent hazard, he could
ask the courts to restrain use or distribution
of the substance immediately.

• The Administrator would be authorized to
issue standards for tests to be performed and
for results to bo achieved from such tests for
various classes and uses of new substances. A
new substance (excluding products covered
by other regulatory authority) could be mar-
keted only after it met these standards.

• The Administrator could request information
from the manufacturers on potentially toxic
substances — names, chemical composition,
production level, uses, and results of tests
cond\icted on theri' effects.

• The Council on Environmental Quality would
be charged with coordinating efforts to estab-
lish a uniform system, for classifying and han-
dling information on chemical substances.
Tlie proposed legislation also authorizes the

Administrator of EPA to carry on needed re-
search on toxic substances and to develop an
information system and prediction capability to
deal effectively with these materials.

Such an information system would focus on
the quantity, distribution, and flow of a par-
ticular substance throughout the environment.
Focusing on the pollutant rather than on the

particular medium being polluted has two ma-
jor advantages: First, a potential problem can
often be rapidly identified, perhaps before dam-
age to health or tlie environment has occurred.
Second, this approach can suggest the most ef-
ficient means of controlling a problem. If the
analysis indicates that most of a substance is
entering the environment through water, then
the most efficient control may be thT'ough water
pollution control laws. If an identified indus-
trial or consumer use of a substance is respon-
sible for the major amount of environmental
contamination, then control of the distribution
and use of the substance may be the most effi-
cient strategy. In sl'ort, pollutant-focused mon-
itoring is capable of giving the decision-maker
the overall view necessary for making key en-
forcement decisions.

For the system of testing, monitoring, and
control authorized in the proposed legislation
to be most effective, the scientific basis of much
of our research must be greatly improved. First,
a broader view of the problem must be taken.
In terms of human health, total exposure of a
human being to a given substance from all parts
of his environment — air, water, and food — ^must
be considered, and the interactions of these sub-
stances both within and outside the body must
be evaluated. Similar consideration must be
given to other living organisms.

Second, testing substances for their effects on
man and the environment must be expanded,
and the scientific basis for interpreting such tests
must be improved. Current scientific knowledge
about data gained from experiments with ani-
mals is often inadequate to allow reliable inter-
pretation of the data in terais of possible effects
on man.

Much effort has already been devoted to toxic
substances monitoring and i-esearch. Much more
will be needed. The proposed legislation would
improve the framework for such efforts, but by
itself it would not bring them to fruition. The

79-313 0 - 77 - 49

762

resources of the Environmental Protection
Agency, the Department of Health, Education,
and Welfare, industry, universities, and many
others both within and outside the Government
will be necessarj' to achieve a truly adequate sys-
tem for assessing the hazards of toxic substances
and for preventing damage from them.

SUMMARY

Recent incidents of mercury and other contami-
nation of the environment and the diversity and
quantities of toxic and potentially toxic sub-
stances entering the en\aronment indicate the
extent of this growing national problem. Ac-
tion is needed to prevent damage to man's health
and the environment. New regulatory author-
ity, improved research, and better monitoring

systems have been recommended and must be
implemented now if protection is to be provided.

The approach called for in the Toxic Sub-
stances Control Act is a new way of looking
at environmental problems. Rather than deal-
ing with pollutants as thej' appear in air, in
water, and on land, it represents a systematic
and comprehensive approach to the problem. It
relies on understanding the flow of potentially
toxic substances throughout the entire range of
activity — from extraction to production to con-
sumer use and to disposal. Only through such a
comprehensive approach can we pro\-ide protec-
tion to man and his environment. In the last few
years, we have identified the enormity of the
problem; we have developed the institutional
capability through the creation of EPA to look
comprehensively at i)ollution of the environ-
ment. The time has come for an action program
to control the use of toxic substances.

763

Contents

Page

Preface yj

Findings and Recommendations iv

Chapter I. Scope and Magnitude of the Problem 1

Metals and Their Compounds 1

Synthetic Organic Compounds 3

Summary 5

Chapter II. Environmental Pathways and Effects 6

Pathways of Environmental Contamination 6

Interactions Within the Environment g

Effects of Toxic Substances 9

Metals and Their Compounds 10

Lead 10

Cadmium 11

Mercur>' 11

Vanadium 12

Synthetic Organic Chemicals 12

NTA (Nitrilotriacetic Acid) 13

ONCB (Orthonitrochlorobenzene) 13

PCB's (Polychlorinated Biphenyls) 13

Summarj' 14

Chapter III. Technological and Legal Controls 15

Technological Methods of Control 15

Product Control 15

Effluent Control 16

Existing Legal Controls 17

Product Control 17

Effluent Control 18

Toxic Substances 19

Inadequacy of Authorities 20

A New System 21

Summary 22

References 23

764

CHAPTER I Scope and Magnitude of the Problem

Until recenbly, the public and the Govern-
ment have been concerned with pollutants
which appear primarily in one medium, usually
air or water. These pollutants — such as sus-
pended solids, particulates, and sulfur oxides —
generally occur in large, measurable quantities.
They can be readily identified with existing
monitoring techniques, and legal authority for
their control is available. Controlling their levels
in the media in which they primaril}^ occur pro-
tects human health and the environment. How-
ever, there are substances, such as radioactive
materials and pesticides, for which research,
monitoring, and control based on media are not
adequate. In the case of radioactive materials
and pesticides, needed regulatory authority and
control procedures have been developed.

There are several types of substances for
which no adequate control authority exists and
for which a total environmental approach is
lacking. Existing authority based on media con-
trol, although sometimes applicable, is not ade-
quate to deal with such substances because they
are present not only in our air, water, and soil
but in all the products that we consume and use
in our everyday lives. Further, control of a
subst-anco in one medium often shifts pollution
to another medium. For the protection of man
and his environment, all sources of exposure
must be considered comprehensively. Chap-
ter I examines major examples of the toxic
chemical substances for which this comprehen-
sive approach is needed and indicates the extent
of the problem presented by them.

Everything in our environment is composed
of chemical substances, and most of these pose
minimal danger to man or the environment.
However, some pose a serious danger — particu-
larly those produced by man's activities. Those
chemicals which damage the environment are
usually called pollutants. Not all pollutants are
of concern as toxic substances. Most common
air and water pollutants, such as particulates
and solids, are not included in the Council study

because existing regulatary authority and con-
trol programs adequately deal with them. For
this reason, radioactive substances, drugs, food
additives, and pesticides are also excluded.

Many other chemical substances are of con-
cern here because of their potentially toxic ef-
fects at extremely low levels of exposure and
their presence in many media. Rather than at-
tempt to be exhaustive given our current incom-
plete knowledge, this report indicates the
problem by using examples of what appear to
be the most pressing areas of concern.

Selected metals, their compounds, and certain
synthetic organic chemicals are perhaps the
best examples of toxic substances which c-an ad-
versely affect man and his environment. They
enter the environment in a variety of ways,
through air and water and through food and
other goods. In this chapter, the magnitude and
pervasiveness of the problem are indicated by
the quantities of potentially toxic substances
produced and the variety of products in which
they are found. The pathways by which these
substances enter the environment and their po-
tential for adverse effects are outlined in Chap-
ter II. Chapter III describes existing and pro-
posed control measures for such substances.

METALS AND THEIR COMPOUNDS

Singly or in combination, the 105 known ele-
ments form the basis of all matter. Of these, 77
are metals. Simply stated, metals are elements
generally characterized by ductility, malleabil-
ity, luster, and conductance of heat and elec-
tricity. Of the 77 elemental metals, 52 can be
considered "eeonomic metals," that is, they are
in sufficient industrial and commercial usage
to warrant collection of statistical production
data. The quantities used vary from millions of
tons for iron and manganese to only thousands
of ounces for iridium. (4-4)
Many, perhaps most, metals are prerequisite

765

to life, usually in trace amourxts. However, some
metals and/or their compounds can and do ad-
versely affect hunmn health if ingested or ab-
sorbed in excessive quantities. A necessity of
life at certain levels, they can be lethal at
increased levels.

Serious adverse environmental and/or health
effects, actual and potential, have been obser^-ed
or indicated for roughly one- fourth of the met-
als in common economic usage today. Many of
the troublesome metals are the so-called "heavy
metals," of which lead and mercurj- are the
most common examples. Table 1 shows the esti-
mated U.S. consumption of sele«te<3 metals for
which adverse human effects have been docu-
mented. Xot included in these estimates are data
for production and release of metals from proc-
esses other than those used to produce the metals
for consumption. For example, Table 1 does not
include the amounts of vanadium released to
the atmosphere from oil combustion or of mer-
curv released from coal combustion.

T.\BLE 1. — Estimated U.S. Consumption of Selected
Metals, 1948 and 1968 (44, 46)

Arsenic (ASjOj)

Barium (barite)

Beryllium (beryl)

Cadmium

Chromium (cbromlte)

Copper

Lead

Manganese (ores, 35% or more

Mn)

B4ercury

Nickel

Selenium

Silver'

Vanadium _..

Zinc

Total estimated
consumption > (in tons)

Percent
increase
1948-1968

1948

1968

24,000

025,000

894.309

1. 590. 000

1.438

8, 719

fxn

3.909

6,664

875,033

1,316.000

1.214,000

1,576,000

1, 133, 895

1.328,790

1,538.398

2.228,412

1,758

2.866

93,558

159,306

419

762

3, 611

4,983

>N.A.

5,495

01,200,000

1,728,400

' Includes stocks released to the open market by the Federal Govern-
ment and imports; does not Include exports.

' Consumption by industry and arts; monetary consumption not
Included because much was stockpiled.

' Figures not available between 1946 and 1956; consumption in 1946
was about 748 tons, in 1955 about 1,700 tons.

After originally extracting metals from the
earth, man reintroduces them into the environ-
ment directly in elemental form or in a wide
variety of compounds. The compounds may
have quite different effects from their elemental
forms; some metals are more toxic as
compounds.

The compounds of metals appear in larger
number than do the metals themselves as inter-
mediate and consumer products For example,
at least 40 lead compounds and more than 45
cadmium compounds are currently in commer-
cial use. {3, 23) The total number of variants
for just two of these metals is thus more than
five times the total number of metals for which
adverse effects have been identified. Most of the
other metals are also used in a wide array of
compounds.

Numerous manufacturing processes and prod-
ucts employ metals and their compounds.
Arsenic, for example, is used in the manufac-
ture of glass, pigments, textiles, paper, metal
adhesives, ceramics, linoleum, and mirrors. {39)
Its compounds are used in wood preservatives
and paints, insecticides and herbicides, and
electrical semiconductors. Berv^llium is used in
several of the above manufacturing operations
as well as in electroplating and as a catalyst in
organic chemical manufacture. Barium is used
in paper manufacturing, fabric printing and
dyeing, embalming, synthetic rubber produc-
tion, and animal and vegetable oil refining. It
is a component of fireproofing compoimds,
x-ray screens, water softening chemicals, enam-
els, lubricants, and photographic supplies. (^7)

These products exemplify' the diversity of
uses of metals and the almost, unending list of
products in which they may be present. When
metals are used in the manufacture of products,
effluents from the operations often contain me-
tallic compounds, which may contaminate the
environment. \Mien metals are present in final
products, direct human contact or environ-

766

mental exposure is possible during use or after
disposal.

The number of metals and related compounds
for which serious environmental concerns arise
will probably increase as technology continues
to find new uses for existing metals and metal-
lic compounds. The increasing consumption of
metals is shown in Table 1.

New products will require the development
of new metal compounds and possibly the ex-
panded use of metals which now have little,
if any, commercial use. Iridium, once only a
laboratory curiosity, is now used to make
jeweler's platinum and to manufacture electric
instruments, penpoints, surgical instruments,
and needles. (40) Beryllium has been used ex-
perimentally in rocket fuels. These new varia-
tions and applications are certain to increase
the potential exposure of man to metals.

SYNTHETIC ORGANIC COMPOUNDS

The Chemical Abstracts Service Registry Num-
ber System has registered some 1.8 million
chemical compounds, and the list is growing by
the addition of 250,000 chemicals each year. (3)
Approximately 300 to 500 new chemical com-
pounds are introduced annually into commercial
use. {4^, 43) Of those which are or may
be used commercially, synthetic (manmade)
organic chemicals are of special concern because
frequently they are alien to the natural envi-
ronment, and in some instances their modifica-
tion, redistribution, or persistence have already
had some dangerous etfects.

Approximately 9,000 synthetic organic com-
pounds were in commercial use by 1968. (47)
As shown in Table 2, production is increasing
rapidly, from over 103 billion pounds in 1967
to nearly 120 billion pounds in 1968, an increase
of about 15 percent. Compared to the 1957-1959
annual average of 46 billion pounds, production

Table 2. — U.S. Production of Synthetic Organic
Chemicals, 1968 ' (47)

Chemical

1968 Production
(in millions
of pounds)

Percent
increase
over 1967

Intermediates

25, 014
226

20.3

Colorants:
Dyes

9.7
1.9

Pigments

Flavors and perfumes

117

16,360
1,331

4.6

18.6
5.4

18.6
11.6
7.6
13.1

Plastic products-
Plastics and resins

Plasticizers

Rubber products:
Processing chemicals

313

Elastomers

4,268
3,739
67, 525

Surfacfi active agents

Miscellaneous.

Total

118, 947

' includes data on production measured at several successive steps in
the manufacturing process and therefore reflects some duplication.

Public disclosure is not permitted by the data-collecting agency when
only one manufacturer produces a chemical. When production of an item
was below 1,000 pounds, or sales below $1,000, a product is not included.
Further, medicinals and pesticides are not included.

increased 161 percent in approximately 10
years. {47) With changes in industrial needs
and technological knowledge, new and more
complex compounds with new and different uses
are constantly l>eing developed.

The synthetic organic chemicals shown by
classes in Table 2 are obtained from coal, crude
petroleum, natural gas, wood, vegetable oils,
fats, resin, and grains. Products are formed by
such processes as thermal decomposition, syn-
thesis, catalytic cracking, distillation, absorp-
tion, or fermentation. Intermediate products
are sometimes consumed directly or may be
further processed. The category of intermedi-
ates in Table 2 refers to those that are consumed
directly.

Dyes and pigments are organic chemicals used
to impart color to other materials. Approxi-
mately two-thirds of the over 1,000 synthetic
dyes consumed in the United States per year
is used in coloring natural and synthetic fibers

767

or fabrics, and about one-sixth is used in color-
ing pa^jer. {4S) The remainder is used chiefly
in the production of organic pigments and in
dyeing plastics and leather. Pigments are used
in paints and related products, in printing inks,
and in plastics and resin materials.

In some cases, pigments contain metals in ad-
dition to their organic constituents. Dyes and
pigments, a part of many everyday products,
find their way into the environment from manu-
facturing operations as well as from ultimate
disposal of consumer products.

Plastics and associated resins and additives,
such as plasticizers, are another major type of
synthetic organic chemical. Plasticizers are
organic chemicals that are added to synthetic
plastics and resin materials to improve work-
ability during fabrication; to extend or modify
the natural properties of these resins; or to de-
velop new, improved properties not present in
the original resins. They . are present in plastic
products in concentrations ranging from less
than 5 to as high as 50 percent. Poly chlorinated
bi phenyls (PCB's), a class of compounds
formerly used in small amounts as plasticizers,
are of considerable environmental concern.

Total U.S. production of plastic products in
1968 was 17.7 billion pounds, 103 percent more
than in 1962. (47," 49) By 1980, total plastics
production is expected to be well over 50 billion
pounds, with production growth at about 10 per-
cent per year through the coming decade. (4-1)

Plastics are used in ever increasing quantities
to replace other materials. Packaging, previ-
ously dominated by glass, paper, and metals,
now employs large quantities of plastics. In some
cases plastics have replaced the traditional pack-
aging materials. "VMien used with other mate-
rials, plastics have improved such features as
strength and appearance.

Polyethylene, polyvinyl chloride, polystyrene,
and ABS (acrylonitrile-butadiene-styrene) res-

ins were first used as packaging in the 1950's.
Volume usage developed about 1960. By 1966,
2.2 billion pounds of plastics were used in pack-
aging, and by 1976, the figure is expected to
reach almost 6.3 billion pounds, a 185 percent
increase. (8) The use of plastics is also increas-
ing dramatically in other areas. Relatively new
is use in automobiles, shoes, handbags, coats,
furniture, dishes, and insulation.

Rubber products can be manufactured from
synthetic organic chemicals (elastomers) which
are formulated with proi^erties similar to
natural rubber. Products made from natural
rubber may contain synthetic organic chemical
additives. Hence, these types of synthetic or-
ganics are commonly found in toys, tires, rain
coats and shoes, carpet backing, garden equip-
ment, tools, and numerous other products.

Surface-active agents, another category' of
synthetic organic chemicals, reduce the surface
tension of water or other solvents and are used
chiefly in detergents, dispersing agents, emulsi-
fiers, foaming agents, and wetting agents. A
major portion— about 550 million pounds— is
used in detergents for both household and in-
dustrial use. (36) The remainder is employed
in processing textiles and leather and in the
manufacture of agricultural sprays, cosmetics,
elastomers, lubricants, paints, pharmaceuticals,
and many other products.

Organic chemicals can be tailored in struc-
ture and properties to fit almost any imaginable
need. During 1968, production of chemicals in
the miscellaneous category shown in Table 2 to-
taled 67,525 million pounds, over half of all
synthetic organic chemicals produced. Examples
of chemicals in this category are some of the
halogenated hydrocarbons, which are used as
solvents in dry cleaning and refrigerants, and
aerosol propellants for hair sprays, paints, and
deodorants. Alcohols, nitrogen compounds, acids
and anhydrides, aldehydes, and ketones are also
included in this category.

768

SUMMARY

Man's physical environment is now exposed to a
myriad of potentiallj' toxic substances. These
substances are the constituents of nearly every-
thing that man uses. In trace amounts in the
human body, some are essential to life; yet in
larger quantities these same substances may be
toxic. The balance betvpeen these two extremes

is often unknown. And because of man's own
activities, other substances not formerly present
are now found in the human body.

The uses of chemical substances are growing
rapidly, many new substances are being formu-
lated, and new commercial applications are be-
ing found almost daily. As Chapter II indicates,
many of this growing array of substances have
already been found to have adverse effects on
man and his environment.

769

CHAPTER II Environmental Pathways and Effects

Chapter I discusses toxic substances, their
quantities, and the diversity of products in
which they are present. Tliis cliapter examines
how these substances enter the environment,
move within the system, and ultimately affect
man and other organisms.

PATHWAYS OF ENVIRONMENTAL
CONTAMINATION

Figure 1 is a simplified diagram of how poten-
tially toxic materials reach man and his environ-
ment. It indicates several key processes: First,

materials are extracted from the environment
in crude form and are successively refined, proc-
essed, and manufactured into more diverse and
complex forms (''Manufacture" in Figure 1).
These diverse processes may produce air and
waterborne wastes to which man may be ex-
posed at each intermediate step. The wastes can
contain not only the original substance but also
considerably modified and perhaps more toxic
substances. The end products are consumed by
man as food or are used as durable and non-
durable goods. This consumption and use can
result in man's further exposure to a substance.
Consumption, however, is not the end of most

FIGURE 1.

PATHWAYS FOR TOXIC SUBSTANCES

MANUFACTURE

MAN

(CONSUMPTION)

— O

■mm

DISPOSAL

770

products, because after they have served their
purpose, they must be disposed of. Except for
direct recycling, disposal methods return mate-
rial to the environment — but almost always to a
different place and often in different chemical
form. Thus, the disposal process alters the pat-
terns of distribution and concentration of sub-
stances which naturally occur in the environ-
ment and may produce new chemical forms
which may be more dangerous to man than the
original substance. As a result of disposal proc-
esses, assimilation by biological organisms may
be facilitated, interaction with other chemical
substances may occur, and inherent toxicity may
be enhanced. These possibilities are suggested
by "Interactions" in Figure 1.

There is a natural background of metal sub-
stances and compounds in the environment to
which biological systems generally have adapted
over the millenia. It is the redistribution and
chemical alteration resulting from man's activi-
ties when he engages in economic exploitation
and disposal which are considered here. Al-
though some substances introduced by man into
the environment may represent a net benefit, for
example, small amounts of fluoride in water
to reduce tooth decay, this report is concerned
with possible adverse effects.

Both metals and synthetic organic chemicals
are potential environmental hazards. However,
significant differences exist in the ways in which
the two types of substances enter the environ-
ment and aSect man.

Metals are recovered from ore deposits either
directly or as byproducts in the course of refin-
ing other metals. Pure cadmium, for example,
is not found uncombined in nature in commer-
cially usable quantities. Commercial quantities
are obtained as a byproduct of smelting zinc.
(3)

During the mining and refining processes,
dusts and gases enter the atmosphere. Metallic
salts formed during these recovery and refining
processes can escape as waste products into sur-

fa-x and ground water. Undesirable concen-
trations of metals and metallic salts in the
environment have been reported from such
sources in a number of cases, including :

• High concentrations of cadmium salts in Mis-
souri mine waters — in one spring the concen-
tration was 1,000 milligrams per liter (25)

• High atmospheric vanadium concentrations
near mining and refining operations (4.)

• Toxic levels of arsenic trioxide emissions from
a gold mine and smelter in the western United
States. (39)

Almost all synthetic organic compounds are
manufactured from crude petroleum, natural
gas, and coal rather than from raw ores. Al-
though extraction and transportation of the raw
materials cause some environmental damage, the
more complex synthetic compounds produced by
manufacturing operations are often the most
toxic.

Waste effluents often result from the manu-
facture of synthetic organic chemicals. These
effluents may be the compounds which remain
unreacted in the production process or the un-
wanted byproducts of the operation. Sludges,
gases, and liquid effluents of varying chemical
complexity and toxicity may be produced. For
example, thermal cracking of crude petroleum
to obtain gasoline or fuel oils can yield phenols,
sulfides, and other organic wastes. Ammonia,
mercaptans, and waste oil effluents result when
reforming is used to produce benzene, toluene,
and other products.

Finally, the diverse end products reach man
and are used. In the course of use, some toxic
materials may inadvertently be introduced into
the environment. One example is the unbumed
or partially burned hydrocarbons from gasoline.
Eventually, most unused residues must be
disposed of, and they enter the environ-
ment through sewage systems, incineration, or
landfill.

Most sewage treatment plants are not capable
of removing many of the toxic substances found

771

in waste water. Secondan,' sewage treatment is
capable of removing a large portion of the
metals, but many synthetic organic chemicals
are unaffected by the biological treatment proc-
esses employed by municipalities. Even if the
toxic substances are removed by treatment, their
presence in sewage sludge may still pose a
problem.

About 10 percent of all municipal solid wastes
are incinerated. During combustion, organic
and metallic materials are converted into a mul-
titude of compounds. Some are partially ox-
idized or reduced and their structure and
properties substantially changed. Some remain
unaltered chemically, changing only physically,
as from a solid to a gas. Some gaseous or par-
ticulate products of combustion are drawn off
through the stacks; those that are not removed
by stack gas cleaning reach the atmosphere. The
solid residue from combustion is often quenched
with water, which then enters the general en-
vironment. Eventually most airborne emissions
return to earth and are deposited on land and
in water.

Materials disposed of at some landfills also
can present a problem. At landfills the volume
of wastes is frequently reduced by open burn-
ing. The resultant particulate and gaseous emis-
sions can cause the same pollution problems
encountered in incineration. Even when the
wastes are buried, leaching of toxic metals or
organic compounds is possible, causing con-
tamination of groimd or .surface water. For ex-
ample, the plasticizers in plastics ma}' be leached
and thus contaminate ground water supplies,
(/i) Regardless of the pollution which may re-
sult, disposal of metals and some chemicals in
landfills represents a waste of valuable re-
sources which could be recycled.

Anotlier possible method of disposal is to
dump wastes in the ocean. The Council issued
a previous report on this subject and concluded
that available methods of land disposal are pref-
erable to ocean dumping. (6)

INTERACTIONS WITHIN
THE ENVIRONMENT

After substances ei\tcr the environment, they
may be diluted or concentrated by physical
forces, and they may undergo chemical changes,
including combination with other chemicals,
that affect their toxicity. The substances may
be picked up by living organisms which may
further change and either store or eliminate
them.

The results of the interaction between living
organisms and chemical substances are often
unpredictable, but such interaction may produce
materials that are more dangerous than the ini-
tial pollutants. One example is inorganic mer-
cury, which was thought to settle safely into
the lx)ttom sediments when discharged into
water. Anaerobic bacteria are now known to
convert inorganic mercurj' into very toxic and
soluble organic mercurv compounds, such as
methylmercury, which pass through the food
chain by aquatic algae and by fish, eventually
reaching man. (37)

DDT, another example, is nearly insoluble in
water. It occurs in high concentrations among
some fish-eating birds as a result of two factors :
DDT's solubility in fats is much higher than in
water, and plankton, shellfish, and fish gener-
ally pass successively higher concentrations of
DDT on to the organism next in the food chain.
Polychlorinated biphenyls (PCB's), which are
chemically similar to DDT, have been found in
similar association with marine food chains.
Oysters exposed to one type of PCB for 96
hours accumulated the substance to a level 3,300
times that of the ambient water. (9)

S\'nergism is another complicating interac-
tion. Two or more compoimds acting together
may have an effect on organisms greater than
the sum of their sejiarate effects. For example,
the toxic effects of mercuric salts are accentuated
by the presence of trace amounts of copper. (4^)
Cadmium acts as a synergist with zinc and

772

cyanide in the aquatic environment to increase
toxicity. {W. 25. 32) Convei"sely, sometimes the
presence of one substance lessens the effect of
another substance on an organism. Arsenic, a
toxic substance itself, counteracts the toxicity of
selenium and has been added to poultrj- and
cattle feed in areas where animal feeds are
naturally high in selenium. (38)

EFFECTS OF TOXIC SUBSTANCES

As noted earlier, inetals, unlike synthetic or-
ganic compounds, have always been present in
the environment, and living organisms — includ-
ing man — have evolved in their presence. Blood
and body tissues are composed of a complex
mixture of elmental substances, including the
metals. Some metals are essential to life at low
concentrations but are toxic at higher concen-
trations. Further, the form in which the metal
occurs — as a pure metal, an inorganic metallic
compound, or an organic metallic compound —
strongly influences its toxicity. Thus the danger
of metals to man depends on their concentration
and chemical form.

Most synthetic organic substances are not es-
sential to life, though many share with metals
the characteristic of toxicity. As with metals,
the concentration and type of exposure to a
particular synthetic organic substance are key
factors in determining its effects.

The total effect of all toxic substances on a
single species, say, man, is impossible to quan-
tify with accuracy because of our lack of know-
ledge about the effects of toxic substances. Al-
though many substances in the environment
can cause death or injury if man is exposed to
them in sufficiently high concentrations, the ef-
fects of long-term exposure to low levels of such
substance^s, singly or in combination, are gen-
erally unknown. A standard text on the dangers
of commercial products rates the toxicity of
more than 1,000 commercially used chemical

compounds, most of which are toxic to man at
high levels of exposure. (IS) However, the long-
term effects of low levels are known for only a
few.

Although lack of effort partially accounts
for this paucity of knowledge, our ignorance
also stems from the many difficulties inherent
in testing for adverse effects. The large number
of chemicals that should be evaluated by long-
term laboratory experiments requiring many
test animals is a serious limiting factor. Ex-trap-
olation of data on dose effects obtained from
animal studies to man must consider many spe-
cies variations in response to exposure from
toxic substances. Substances rarely occur in the
environment in isolation, so that possible syner-
gism or antagonism of two or more substances
adds to the difficulty of adequate testing and of
interpretation of field results.

Difficult choices must also be made in deter-
mining the effects or biological end points to be
examined. Biological end points are often deter-
mined from such irreversible effects as carcino-
genesis, mutagenesis, and teratogenesi^.

Carcinogenesis is the ability of a substance to
cause cancer. Chemical mutagenesis is the induc-
tion in protoplasm of genetic mutations by a
substance. These can be permanent and trans-
missible changes in the genes of an offspring
from those of the parents of earlier generations.
Teratogenesis is the production of physical or
biochemical defects in an offspring during ges-
tation ; it is limited to a particular cliild. During
the last decade, there were many deformed in-
fants bom of women who had ingested the drug
thalidomide during pregnancy — a vivid exam-
ple of teratogenesis.

The effects of any given substance may vary
among individuals and among species. Differ-
ences in effects are a function of age, sex, health
condition and history, stress, different meta-
bolic patterns in different species, and other
less understood factors. Further, we often do
not know how to apply to humans the results

from experiments with laboratory animals. If
a substance produces cancer in mice, will it pro-
duce human cancers? How do we extrapolate
the level of a substance required to produce a
given effect in mice to the level that will pro-
duce tlie same effect in man? If mice are not
affected by a subst^ince, is that substance also
safe for humans?

All these difficulties contribute to the dearth
of knowledge concerning the biological effects
of many environmental contaminants and par-
ticularly the toxic substances discussed in this
report. But we do understand enough to know
that many substances may significantly threaten
man and the environment.

Many useful data on health effects of toxic
substances derive from studies of occupational
exposure. Commonly, the levels of exposure are
much higher at the workplace than in the total
environment, and the data gathered on exposed
groups of workers can contribute to understand-
ing effects on the general population. However,
even here caution must be exercised in inter-
preting the results for nonindustrial groups who
are exposed to lower concentrations and whose
level of health may not match that of the in-
dustrial worker.

A few examples will illustrate the ways in
which toxic substances have become a part of
our environment and have affected humans.
These examples are not in any way intended to
be exhaustive or definitive. All of the limita-
tions cited above ooncemijig data on effects ap-
ply to the examples, and the data given are used
simply to illustrate, in a selective way, the basis
for concern over toxic substances.

Metals and Their Compounds

The potential for dangerous metals' entering the
environment is indicated by the consumption
data in Chapter I. Studies of ambient condi-
tions substantiate these data: Twenty -seven
trace elements are found in the atmosphere. (33)
A survey of eight heavy metals in U.S. waters

showed that these metals were distributed in
low concentrations. (10) Their level in drink-
ing; water generally did not exceed stfoidards
but did indicate potential problems in some
areas.

Examples of the toxic effects of metals are
readily found. Compounds of nickel and beryl-
lium, which accumulate in the lungs, may cause
fatal diseases. (33) If inhaled, barium can cause
respiratory disease, or if ingested in sufficient
quantities, it causes heart, intestinal, and nerv-
ous system disorders. (27)

Some laboratory experiments indicate that
exposure to metals may interfere with vital
chemical reactions. In a study of rats and mice
living in a carefully controlled environment rel-
atively free from metal contamination, the sam-
ple group lived 20 to 25 percent longer than the
control group in its usual contaminated environ-
ment. (33) In addition, laboratorj' breeding
mice exposed to concentrations of cadmium,
lead, or selenium produced abnormal offspring.
Long periods of arsenic and molybdemun ex-
posure changed the sex ratios of mice and rat
offspring. Antimony, in low doses, shortened the
lifespan of rats. (33)

Lead— Lesvd is one of the oldest known pol-
lutants. In the second century B.C., the wealthy
class of Rome was decimated ty sterility, child
mortality, and permanent mental impairment.
{12) According to one theory, this decline can
be traced to lead poisoning from wine and food
vessels. The lower classes survived because they
could not afford lead utensils.

Today lead is absorbed by humans in a more
democratic way, because all social classes are
exposed to lead in the atmosphere. Lead par-
ticles in the air eventually settle to land and
water, mixing with other sources of the metal
and following complex pathways in the envi-
ronment. The increase in lead pollution is now
global in scope. For example, between 1904 and
1964, lead concentrations in Greenland snow
increased 16-fold. (28)

79-313 O - 77 - 50

774

A variety of industrial and mining effluents,
disposal of consumer products suclv-^s auto-
mobile batteries, and various food products all
contribute to both environmental and human
accumulation of lead. However, these sources are
small contributors to lead pollution compared
with combustion of leaded gasoline. In 1968
alone, 180,000 tons of lead were omitted from
leaded-gasoline combustion — 14 percent of all
lead consumed in the United States that year.
ill)

Although the acute toxicity of lead has been
a health problem for 2,000 years, the effects of
ambient levels are not known. Acute poisoning
is still a frequent problem, primarily among
children who have eaten chips of lead-based
paint in older dwellings. The use of lead-based
paint is now restricted, but there are still many
old houses whose walls are covered with lead
paint applied years ago. Aside from this prob-
lem, the critical question today is whether the
total body burden produced by inhaling air
polluted with lead and by drinking water con-
taining small amounts of lead is sufficiently large
to produce any adverse effects. The data are not
conclusive, but in the opinion of at least one
recognized expert, "There is little doubt that
at the present rate of pollution, diseases due to
lead toxicity will emerge within a few years."
{33)

Cadmium — Like most metals, cadmium is
stable and does not degrade in the environment.
Thus, as increasing amounts of cadmium are
refined, more and more of it is circulated in
the environment, and increasing amounts may
reach man.

Only a fraction of the cadmium taken into
the body is actually absorbed by the body. The
cadmium which is absorbed accumulates in the
kidneys and the liver, and because there ap-
pears to be an inefficient excretory mechanism
in humans, accumulation tends to increase with
increased absorption.

The effects of such accumulation vary accord-
ing to the amount and time period of exposure.
Some preliminary studies indicate that ex-
posure to low levels of cadmium from sources
present in the everyday environment may lead
to hypertension and heart disease and perhaps
to cancer. (5, 30^ 34-)

Many sources contribute to the accumulation
of cadmium in humans. The metal is found in
concentrations of 50 to 170 parts per million in
superphosphate fertilizers, and it is also used
in some pesticides. (3) Cadmium becomes an
air and water pollutant through a variety of
industrial processes, and it is being used in
increasing amounts by the storage battery,
plastics, plating, and petroleum industries. Ad-
ditional amounts are introduced into the home
by the pipes which carry drinking water. (33)
Food is another major source of cadmium — it
has been found in a variety of products, from
dry cereal to vermouth. (29)

Mercury — Although poisoning from mei'cury
has been recognized as an occupational hazard
for years, concern with mercury as a general
environmental contaminant in the United States
is quite recent.

Metallic mercury was long thought environ-
mentally inert. When discharged into a river,
for example, it was believed to settle to the
bottom and remain there. Then in 1960, it was
reported that 111 persons had died or suffered
serious neurological damage near Minamata,
Japan, as a result of eating fish and shellfish
which had been contaminated by mercury dis-
charged into Minamata Bay by a plastics manu-
facturing plant. (J) In 1965, another poisoning
incident was reported in Niigata, Japan, and
in 1966, Swedish studies indicated that many
species of birds were being jwisoned by mer-
cury. (18) Other Swedish studies pinpointed
the critical facts that metallic mercury, previ-
ously thought inert, can be changed by baxiteria
into methylmercuj:^ — a compound that is fax

775

more toxic than metallic mercury — and that
methylmercury can enter the food cycle through
uptake by aquatic plants, algae, lower forms
of animal life, and fish. (17, 21) Even more
significantly, the studies showed that the con-
centration factor in the fish could be 3,000 or
more to 1. (IS) Thus, harmless levels of mercury
in water can be concentrated to hazardous levels
in fish.

In 1967, large amounts of methylmercury
were reported in fresh-water fish in Sweden.
[21) A study submitted in the same year to the
U.S. Public Health Service concluded : "From
our review of mercury as an environmental
chemical contaminant, it is obvious that a con-
siderable amount of mercury has been cycled
through our environment. . . . We have little
or no information as to where the mercury that
is being cycled through our environment is go-
ing." {2!t) The report recommended expanded
monitoring and study of the health effects of
mercury.

Finally, in the spring of 1970, high levels of
mercury were discovered in fish in Lake St.
Clair, on the Canada-U.S. border. Canada
banned the .sale of fish from the Lake, and 10
days later Michigan followed suit. In succeed-
ing months, there followed a series of bans,
mostly of fish and seafood products containing,
or suspected of containing, excessive mercury.
These actions resulted in losses of millions of
dollars to the food, canning, and tourist
industries.

The concern over mercurj' is well founded.
Some organic mercury' compounds are accumu-
lated in humans, concentrating in the brain, the
kidney, the liver, and the fetus. They can de-
stroy the cells of the brain, cause tremors and
mouth ulcers, and produce birth defects because
of chromosome -breakage. [19)

The sources of mercury are numerous. It is
used in a number of industrial processes and
appears in such varied products as paints, elec-
trical apparatus, thermometers and other in-

struments, and cosmetics. Primary concern has
focused on mercury as a water pollutant, largely
because it is now known to reach the food chain
by water, but the metal is also present in soil
and in air.

Vanadium — Very little research has been done
on the toxicity of environmental concentrations
of vanadium. When the route of exposure is the
respiratory tract, vanadium may accumulate in
the lungs. High concentrations of the metal may
damage human gastrointestinal and respiratory
tracts. (4) Exposure to lower concentrations
has resulted in inhibition of cholesterol synthe-
sis in man. (^)

Trace amounts of vanadium are natural to
all humans, but it is probably a recent addition
to the atmosphere. There is no evidence that
ambient levels of vanadium are toxic. But these
levels have been increasing in recent years due
to the burning of fuel oils containing vanadium
and to increased industrial use of vanadium
compounds. Eighteen compounds of vanadium
are now used in a wide variety of commerical
processes. (^4)

Synthetic Organic Chemicals

A vast number of synthetic organic chemicals
is being introduced into the environment, and
many of these chemicals have not been identi-
fied. A study prepared for the Water Quality
Office of the Environmental Protection Agency
reported that 496 organic chemicals were found
or suspected in fresh water, but the chemical
composition of only 66 of these was identified.
(22) The disparity between the number re-
corded and the number identified indicates the
need for better monitoring and analytical tech-
niques. It also shows the difficulty of dealing
with such substances once they have entered the
environment.

Some organic compounds have been identified
as tumor-producing in experimental animals.

776

A smaller number have been singled out as cap-
able of causing cancer in humans. Kesearch on
teratogenic effects has been limited, but a few
chemicals have been shown to be teratogenic in
humans in doses corresponding to those which
might be expected in the environment. So little
testing has been conducted on the mutagenic
effects of synthetic organic chemicals that al-
most nothing is known about such effects.

Discussed below are three example of syn-
thetic organic chemicals which have posed some
hazard to human health or the environment.

NTA (Nitrilotriacetic Acid)— ^TA recently
came into extensive use as a substitute for
phosphates in detergents. Until a couple of
years ago, almost no NTA was used. NTA, a
substance with which the consumer has sud-
denly come into direct contact, may enter the
general aquatic environment in large quantities
through flushing into sewers and septic tanks.
If NTA proved safe, an estimated 600 million
pounds would have been used annually in de-
tergents by 1973. (36) Because of its concern
with water pollution caused by detergents, the
Federal Government studied the health and en-
vironmental effects of NTA and other phosphate
substitutes. Preliminary results indicated that
NTA may combine with cadmium, mercury, and
other met^ils to enhance the toxicity of these
metals. Therefore, the major detergent manu-
facturers recently agreed not to use NTA until
completion of testing now underway.

ONCB (Orthonitrochlorobenzene) {26)—
ONCB is an unusable byproduct in the manu-
facture of paranitrochlorobenzene, a chemical in
wide commercial use. In 1958, this unique and
persistent chemical was found at levels of .021
parts per million in water samples taken at mon-
itoring stations between St. Louis and New Or-
leans. Concentrations of 0.03 parts per million
of ONCB were found in treated drinking water,
indicating that ONCB survived normal potable

water treatment procedures. Few studies have
been done on the effects of ONCB, but it was
calculated that 5 to 50 parts per million would
be lethal to humans and that 0.5 to 5 parts per
million would cause clinical symptoms.

Although concentrations of ONCB in the
water were not toxic, the Public Health Serv-
ice concluded that the safety factor was not
adequate, the chemical was remarkably persist-
ent, and normal water treatment was inade-
quate. On the basis of this analysis, the source
of the ONCB agreed to remove waste streams
containing ONCB from the river.

PCB's (Polychlorinated Biphenyls)— The

molecules of plastics are generally inert and
nonreactive. Problems arise because of certain
types of plasticizers, dyes, oxidation retardants,
and various stabilizers which are added to plas-
tics. These additives are not always chemically
bound to the plastic molecules and thus may be
released into the environment. PCB's, also
known as Aroclors, are such a group of
additives.

PCB's are among the more persistent^organic
chemicals — they degrade very slowly in the en-
vironment. In addition to their use as plasti-
cizers, they have also been used in paint,
electrical transformers, and lacquer resins and
as lubricants, heat transfer fluids, and "carriers"
for some insecticides. Structurally, PCB's re-
semble DDT, and like DDT, they are not soluble
in water but are fat soluble and therefore can be
absorbed by human tissue. The resemblance to
DDT goes further. PCB residues have been
found in fish and wildlife around the world.
Normally used analytical methods find it diffi-
cult to differentiate between DDT and PCB's.

In April 1969, PCB's were first detected as
residues in oysters in Escambia Bay, Florida.
Further sampling indicated the presence of
PCB residues in the water, sediment, fish, blue
crabs, and shrimp. The substance was traced to
a leak from an industrial plant 6 miles upstream

777

from the Bay. PCB was being used there as a
heat exchange fluid, and the leak was not known.
The leak has l)een stopped, but PCB's are still
present in the Bay. albeit in decreasing amounts,
apparently leaching from river sediments. (9)

Tests with PCBs have shown that 0.1 parts
per million were fatal to juvenile pink shrimp
after a 48-hour exposure, and the same concen-
trations stopped oyster shell gro\\-th in 96 hours.
In laboratory test-s. shrimp, pinfish, and o\-sters
all concentrated PCB. (9) U.S. Fish and Wild-
life Service workers have correlated the lethal
effects of PCB's on game birds directly with the
chlorine content of PCB. (15)

PCB's have also been found in Great Lakes
fish and in human fatty tissue. (31) A study of
human tissue samples showed concentrations of
from less than 1.0 parts per million to as high
as "250 parts per million. Fifteen percent of the
samples e.xceeded 1.0 parts per million PCB's.
(31) Another study showed that over half the
urban residents examined had traces of PCB
in their blood. (11)

SUMMARY

This chapter discusses the many pathways by
which toxic substances enter the environment.
Such substances are found in air, water, soil,
food, and a variety of consumer products. Once
they enter the environment, complex changes
can take place which can alter their chemical
form and change the ways in which they affect
man.

The effects of toxic substances on man vary
according to the type of substance, the amount
of the substance to which a person is exposed,
the duration and method of exposure, and sev-
eral other factors. There is ample evidence that
many metals and synthetic organic chemicals
can pose hazards to human health.

Effects on human health are the primarv' con-
cern of this dhapter. Effects on wildlife, agri-
culture, and other parts of the ecosystem pose
additional problems, but the effects of toxic sub-
stances on ecosystems have been even less well
explored by scientists thaii the effects of such
substances on man.

778

CHAPTER in Technological and Legal Controls

This chapter details methods for controlling
the introduction of toxic substances into
the environment. Technological controls are
discussed as background for evaluation of insti-
tutional and legal authorities available.

trol of a product and its uses, including total
prohibition of the product, and control of the
effluents. The alternatives and their relation-
ship to the pathways by which contaminants
enter the natural environment are shown in
Figure 2. Each is discussed briefly.

TECHNOLOGICAL METHODS
OF CONTROL

Several control strategies exist for almost all
the substances included in this study because
each enters the environment in numerous ways.
The strategies are of two general types: con-

Product Control

Control of products ("1" in Figure 2) to reduce
contamination of the environment can be ef-
fected by either reducing the input of the raw
material of concern or changing the nature of
the end products.

FIGURE 2.

CONTROL STRATEGIES FOR TOXIC SUBSTANCES

779

From a materials balance analysis, reducing
the amount of a contaminant that is initially
used ultimately reduces the amount that can
enter the environment from effluents, reg;ardless
of the number or complexity of intermediate
steps. Also, to the extent that the total body
burden for a given substance or its accumula-
tion in a target organ is important, this control
point may be the easiest at which to determine
the absolute reduction required.

For example, fuel oils contain varying con-
centrations of metals. In the future we may
have to look to fuels with low concentrations
of highly toxic metals, just as we look to low-
sulfur fuels today. Fuel oil combustion is chiefly
responsible for vanadium concentrations in the
atmosphere. Residual oil imported from Vene-
zuela has up to 63 percent vanadium i)entoxide
in ash, compared with 14 to 38.5 percent for
oil from Iran and 0.4 percent, 1.4 percent, and
5.1 percent for oil from Kansas, Texas, and
California, respectively. (35) Changing to low-
vanadium fuel is a control that could be used
to reduce atmospheric vanadium concentrations
if such reduction were necessary.

Changing end products or prohibiting their
production is an important control technique
because man is directly affect-ed by these prod-
ucts and by their disposal — through interaction
with the environment and through further in-
teraction with man. Simply changing an in-
gredient can also effect a desired change. For
example, lead has been used in paint to ac-
celerate drying; its harmful effects can be
eliminated by removing it from the product for-
mulation and substituting another less toxic or
nontoxic material.

Certain plastic products have used plasti-
cizers which were persistent and unon disposal
could cause damage to wildlife. Replacing them
with other materials has alleviated the disposal
problem without robbing the product of desired
physical characteristics.

Control over use of a product is often suc-

cessful in reducing or eliminating damage
caused by the product. The circumstances under
which products such as drugs or pesticides can
be used are carefully regulated because of the
severe damage which can result if they are
misused. Many toxic substances can be used
safely if human exposure is prevented. For
example, the manufacturer of PCB's agreed
to limit their use to closed systems, thus prevent-
ing damage by preventing their entering the
environment.

Effluent Control

A second method of controlling the introduction
of pollutants into the environment is to change
the production process to eliminate or to con-
trol the effluents.

Changes in production processes may, in some
cases, significantly reduce the quantities of con-
taminants that are discharged as effluents or
that become intermediate or final products. For
example, improving the efficiency of synthetic
organics production can reduce the volume of
toxic or potentially toxic effluents. Yields of
organic products are rarely, if ever, 100 percent.
Remaining chemical constitutents are usually
wastes, which may be recovered, treated, or
released to the environment. Hence, to the
degree that production is made more efficient
and more of the raw material is utilized, wastes
released to the environment are reduced.

Similarly, changes in production processes
can change byproducts or wastes to less toxic or
less persistent compounds. Some carcinogenic
organic compounds are produced by burning
coal and refuse. Improving combustion effici-
ency lowers the concentration of the carcinogens
emitted.

Controlling effluents from manufacturmg
processes and from end product disposal has
been the most widely used technique for con-
trolling pollutants. The processes used are re-

780

cycling, waste treatment, or other kinds of
disposal.

When the contaminants are of high value, as
some metals are, recycling not only protects the
environment but may also be the major source
of the mineral. For example, arsenic, cadmium,
and selenium occur in such low natural con-
trations that they are not mined for themselves
but are recovered during the refining of lead
and zinc, among other metals. Similarly, be-
cause mercury is expensive, much of it can be
economically recovered from efflueats for reuse.

Recycling synthetic organic chemicals is
more difficult than recycling metals and their
compounds due to their complex molecular
structures and to the economics of recovery.
However, recycling rather than disposal is some-
times possible. Instead of incinerating scrap
plastics, some scrap can be remelted for reuse
in fabrication.

Treatment of wastes is also useful in prevent-
ing the harmful interaction of contaminants
and the environment. Arsenic, nickel, and vana-
diiun are usually airborne contaminants result-
ing from smelting other metallic ores. These
toxic substances are commonly emitted with
particulates. Therefore baghouse filters, wet
scrubbers, and electrostatic precipitators which
remove substantial quantities of particulates
also reduce emission of these toxic metals. The
resultant ash and metals can then be carefully
disposed of or recycled. For example, an electro-
static ]>recipitator which effectively reduces
particulate emissions also reduces arsenic con-
centrations from a range of 5 to 17 parts per
billion before treatment to 0 to 4 parts per bil-
lion after treatment. (39)

Effluents can also be neutralized before final
disposal. Metals converted to metallic salts or
sulfides can be dis[)osed of more safely. Also,
some potentially toxic synthetic organics can be
treated. Before disposal, phenols — a byproduct
of some svnthetic organic processes — can be
decomposed by biological action into carbon

dioxide and water, two harmless, natural chem-
ical components.

EXISTING LEGAL CONTROLS

L^al authorities available to control pollu-
tion parallel the technical methods of control.
A product is controlled by regulating the
amount manufactured and the uses permitted.
For some products the processes of manufacture
are regulated. Effluent control has generally
involved the establishment and enforcement of
standards for levels of air or water pollutants.

Product Control

The Federal Government exercises some con-
trol over the manufacture and distribution of
pesticides, drugs, food additives, consumer
products, and radioactive materials. Each of
these authorities differs somewhat from the
other.

Pesticides are regulated under the Federal
Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (7 U.S.C. 135-135k), enacted to pro-
tect the user and handler of pesticides by re-
quiring registration, proper labeling, and in
some cases coloring of pesticide products. The
FIFRA regulates the marketing, in interstate
commerce, of "economic poisons and devices,"
which includes insecticides, rodenticides, plant
defoliants, and household disinfectants.

The FIFRA requires registration of pesti-
cides with the Administrator of the Environ-
mental Protection Agency (EPA). The manu-
facturer must submit data to establish the
safety and efficacy of a pesticide along with
the label proposed for the product. This infor-
mation is reviewed to determine that the label
contains adequate directions for use and ade-
quate warnings to a.ssure that handling, storage,

781

or use of the j^roduct will not result in injury or
damage when used as directed. Through the
registration procedure and its approval of la-
beling, EPA can control whether a pesticide
will be marketed and. if marketed, the particu-
lar crops on which it will be used. There is no
provision for control over application of the
pesticide, but the Administration has submitted
a new, comprehensive pesticides bill which
would remedy this and other defects in the
existing law. The Food and Drug Administra-
tion (FDA) also enforces pesticide regulations
through examination of food to insure that the
pesticide residues do not exceed allowable
limits.

FDA. under the authoritv of the Food. Drug,
and Cosmetic Act (21 TLS.C. 301 et seq.), regu-
lates food labeling, food additives, food con-
tainers, drugs, and cosmetics. Particularly tight
controls are exercised over drugs. Before they
are marketed, drugs must be registered and ap-
proved by FDA. They must be properly labeled
and must be safe and effective when used as di-
rected or suggested. Drug producers must reg-
ister their plants, which are subject to close
inspection by FDA. Manufacturers and han-
dlers of depressant or stimulant drugs must keep
extensive records of the type, quantity, and dis-
position of such drugs.

Regulation of foods, foot! additives, and cos-
metics is less stringent. Food standards can be
prescribed for identification, quality, and fill of
containers. Xew food additives must be cleared
prior to use. FDA can prohibit the use of par-
ticular food additives or establish tolerance
levels for the amount to be used. Although pre-
clearance is not. required for cosmetics, they
must, not contain poisonous or deleterious sub-
stances; they cannot he produced or held in
unsanitary conditions or packaged in a container
which renders the contents injurious to health;
and they must be fairly and accurately labeled.

Radioactive materials are the most closely

i-egulated of all substances. Under the authority
of the Atomic Energy- Act of 1954, as amended
(42 r.S.C. 2011 et seq.), the Atomic En-
ergy Commission (AEC) regulates almost the
entire spectrum of activity associated with the
handling, transportation, and disposal of radio-
active materials. Specifically, the AEC licenses
and maintains continuing surveillance over fa-
cilities utilizing, processing, or disposing of ra-
dioactive materials. It also prescribes procedures
and standards for packaging and shipping such
materials.

Effluent Control

There are two major statutory authorities for
controlling the relpa?e of {X)llutants directly
into the environment — the Federal TVater Pol-
lution Control Act (33 U.S.C. 466 et seq.) and
the Clean Air Act (42 U.S.C. 1857 et seq.) . Both
ha\ e been extensively amended since enactment,
and the Congress is now considering further
major changes in the Water Pollution Control
Act.

The Federal Water Pollution Control Act
provides for establishment of Federal-State
water quality standards for interstate and
coastal waters. Standards for all States have
been appro^•ed by the Federal Government, al-
though standards for some interstate waters
and some measures of quality have not yet been
established. These standards basically cover gen-
eral parameters of the water— such as oxygen
content, temperature, and turbidity — rather
than specific substances in the water. Although
the standards may be enforced directly by the
Federal Government, primary' responsibility for
enforcement rests with the Statues.

Early in 1970 and again in 1971, the Admin-
istration submitted to the Congress amendments
to the Water Pollution Control Act designed to
broaden the Act's coverage and to simplify the
enforcement process. The amendments would

782

extend the coverage of water quality standards
to all navigable waters, ground water, the con-
tiguous zone, and the high seas with respect to
discharges emanating from U.S. territory ; and
they would authorize establishment of effluent
standards for all such waters. The Government
also recently announced a program based on the
1899 Refuse Act, which requires a Federal per-
mit to discharge effluents other than mimicipal
sewage. The Refuse Act authority will serve as
the basis for a national system of controlling
industrial pollution.

The Clean Air Act has provided for a system
of Federal-State establishment of air qual-
ity standards. However, comprehensive amend-
ments to the Act (Clean Air Amendments of
1970 (Public Law 91-604) ) passed recently re-
quire the Federal Government to establish na-
tional air quality st-andards and require the
States to submit emission standards for individ-
ual pollutants for Federal Government ap-
proval. Further, the amendments require Fed-
eral establishment and enforcement of emission
standards for certain classes of new industry
and for hazardous air pollutants.

In addition to air and water pollution control,
the Federal Government is concerned with solid
waste disposal. However, the Solid Waste Dis-
posal Act (42 U.S.C. 3251-3259) and the amend-
ments contained in the Resource Recovery Act
of 1970 (Public Law 91-512) do not authorize
Federal regulation but deal primarily with re-
search and demonstration of improved methods
of disposal. The Resource Recovery Act does
require the formulation of a plan for a system of
national disposal sites for the storage and dis-
posal of hazardous wastes. Many State and
local governments promulgate disposal regula-
tions, but in the main the regulations are con-
cerned with visible smoke, not with toxic
substances. Xo laws or regulations are directed
at the problems which may be created by the
disposal of potentially toxic materials.

Toxic Substances

Existing law does not entirely ignore the types
of substances dealt with in this study. Toxic
substances are specifically dealt with in the
Hazardous Substances Act (15 U.S.C. 1261-
1273), section 12 of the Federal Water Pollu-
tion Control Act (33 U.S.C. 1162), the recent
amendments to the Clean Air Act, and the au-
thorities of the Department of Transportation
relating to transportation of hazardous
substances.

The Hazardous Substances Act covers house-
hold products and toys — but not the raw mate-
rials from which they are manufactured. Thus
it does not deal directly with most of the toxic
substances of concern in this report. Primarily
the law authorizes the Secretary of Health, Edu-
cation, and Welfare only to require how a
product should be labeled. Although the Act
does allow extremely hazardous products to be
banned from interstate commerce, the definition
of a "hazardous substance" is quite restrictive,
stating that a substance may be ba:med only if
special labeling or packaging is found ineffec-
tive in preventing a hazard. Only three house-
hold products have been banned.

Section 12 of the Federal Water Pollution
Control Act authorizes the President to desig-
nate hazardous substances and to recommend
methods and means for their removal from
water. Under the section (33 U.S.C. 1162(a)),
"hazardous substances" is limited to "such ele-
ments and compounds which, when discharged
in any quantity into or upon the na\-igable
waters of the United States or adjoining shore-
lines or the waters of the contiguous zone, pre-
sent an imminent and substantial danger to the
public health or welfare . . ." The section is
generally aimed at accidental discharges of
such substances into water and thus does not
cover either continuous discharges into water or
release of hazardous substances into other media.

783

The Clean Air Amendments of 1970 contain
a section directed specifically at hazardous sub-
stances and also authorize the Administrator
of EPA to regulate the use of fuel additives.
Section 112 requires the EPA Administrator
to publish a list of air pollutants which are not
covered by air quality standards and which
"may cause, or contribute to, an increase in mor-
tality or an increase in serious irreversible, or
incapacitating reversible, illness." The Admin-
istratoi' must then s^t and enforce national emis-
sion standards for these pollutants. A similar
section has been included in the Administra-
tion's proposed amendments to the Water Pol-
lution Control Act.

The Department of Transportation (DOT)
regulates interstate transportation of hazardous
substances under several authorities, including
the Department of Transportation Act (49
U.S.C. 1651 et seq.), the Transportation of Ex-
plosives Act (18 U.S.C. 831-837), and the Haz-
ardous Cargo Act (46 U.S.C. 170). DOT
has defined several classes of hazardous
materials (49 C.F.R. Parts 170-179), and its
Hazardous Materials Regulations Board plans
further classification based upon health hazard
(35 Fed. Reg. 8831, June 6, 1970). Although
some testing for effects of hazardous substances
is involved in the implementation of these regu-
lations, substances are classified primarily from
the perspective of hazards involved in their
transportation and possible spills from acci-
dents. Most of the problems of toxic substances
discussed in this report relate to aspects of their
use rather than to transportation and spills.

Inadequacy of Authorities

It is clear that current laws are inadequate to
control the actual and potential dangers of toxic
substances comprehensively or systematically.
The controls over manufacture and distribution

pertain to only a small percentage of the chemi-
cal substances which find their way into the
environment. Almost all the effects described in
Chapter II relate to substances not covered
by present controls over manufacture and
distribution.

Both controls over production and controls
over effluents suffer from the limited focus of
their authority. For example, the Food and
Drug Administration carefully examines food
containers for their effect on food but does not
address the environmental and health effects
of incinerating the containers. With the excep-
tion of radioactive materials, disposal is not a
consideration in any programs controlling
manufacture.

But the problems of focus are broader than
specific examples. Setting rational standards for
many pollutants under existing legislation is
almost impossible. The key factors involved in
setting standards are the total human exposure
to a substance and its total effect on the envi-
ronment. The focus must be on a particular pol-
lutant and all the pathways by which it travels
through the ecosystem. Controls over distribu-
tion approach this perspective, but most fail to
consider important environmental factors
adequately.

The obvious limitation of controls over efflu-
ents is that they generally deal with a problem
only aft^r it is manifest. They do not provide
for obtaining information on potential pollut-
ants before widespread damage has occurred.

More subtle but more serious limitations of
effluent controls arise from their focusing on the
media— air or water— in which the pollution
occurs. This approach has several consequences :
First, it leads to concern with those substances
found in air or water in the greatest quantities.
For example, the Air Pollution Control Office
uses the gross weight of air pollutants as one
indicator of the severity of air pollution. Gross
weight is a valid indicator, but it disregards

784

the degrees of danger of the various pollutants.
As indicated in Chapter II, comparatively
small amounts of some substances can cause
severe damage, but media-oriented programs
tend to overlook the importance of such sub-
stances. Another consequence of the media ap-
proach is that it cannot deal effectively with
the fact that many, perhaps most, toxic sub-
stances find their way into the environment
through several media. They cannot be char-
acterized strictly as water pollutants or as air
pollutants, for they are found in air, in water,
and often in soil, food, and other parts of the
environment. The characteristic pervasiveness
of toxic substances makes it difficult for the
media-oriented programs to engage in adequate
and efficient research, monitoring, and control
activities for such substances. The need for such
a comprehensive approach was a major ration-
ale for the creation of the Environmental Pro-
tection Agency (EPA) .

The scope of EPA's authority provides a
basis for an integrated approach to toxic sub-
stances. However, such an approach cannot be
accomplished simply by coordinating the activi-
ties of existing media-oriented programs. The
activities themselves must be conducted on an
integrated basis. Testing to determine the health
or environmental effects of a substance must be
done in terms of total exposure to the substance,
not simply exposure through air or through
water. There must exist a capability for inte-
grating the monitoring data from various media
and for doing nonmedia analyses, for example,
utilizing the materials balance approach. (This
approach compares the total amount of a sub-
stance produced with the amount appearing in
various end uses. A disparity between the two
indicates the approximate amount escaping into
the general environment.) Finally, there must
exist authority to insure that the effects of a new
substance are carefully examined before it en-
ters the air, soil, or water.

A NEW SYSTEM

The shortcomings of the legal authorities de-
scribed above, the effects of toxic substances
outlined in Chapter II, their increasing number
and amounts indicated in Chapter I, and the
inade-quate attention paid to such substances
all support the need for a new legal and insti-
tutional system to deal with toxic substances.

Our awareness of environmental threats, our
ability to screen and test substances for adverse
effects, and our capabilities for monitoring and
predicting, although inadequate, are now suf-
ficiently developexi that we need no longer re-
main in a purely reactive posture with respect
to chemical hazards. We need no longer be lim-
ited to repairing damage after it has been done;
nor should we allow the general population to
be used as a laboratory for discovering adverse
health effects. There is no longer any valid rea-
son for continued failure to develop and exer-
cise reasonable controls over toxic substances
in the en\nronment.

In February 1971, the Administration sub-
mitted to the Congress a bill developed by the
Council on Environmental Quality in consulta-
tion with EPA and other agencies, entitled The
Toxic Substances Control Act of 1971. The bill
contains two new, major authorities:
• The Administrator of the Environmental
Protection Agency would be empowered to
restrict or prohibit the use or distribution of a
chemical substance if such restriction were
necessary to protect health and the environ-
ment. In imposing such a restriction, the Ad-
ministrator would be required to consider not
only the adverse effects of the substance but
also the benefits to be derived from use of
the substance, the normal circumstances of
use, the degree to which release of the sub-
stance or its byproducts to the environment
is controlled, and the magnitude of human
and environmental exposure to the substance
or its byproducts.

785

• The Administrator would be authorized to
issue standards for tests to be performed and
for results to be achieved from such tests for
various classes and uses of new substances. A
new substance could be marketed only after
it met these standards. Consumer products
(insofar as their household use is hazardous) ,
pesticides, drugs, and other kinds of sub-
stances which are already regulated would
continue to be regulated under existing au-
thorities rather than under the Toxic Sub-
stances Act.

In addition to these two authorities, the bill
contains several other significant provisions. If
the Administrator believed that a substance
were creating an imminent hazard, he could ask
the courts to restrain use or distribution of the
substance immediately. The Administrator
would be authorized to develop the resources
necessary to predict introduction of new chemi-
cal substances into the environment and to
assess the environmental consequences of their
introduction. The Council on Environmental
Quality would be charged with coordinating
efforts to establish a uniform system for classi-
fying and handling information on chemical
substances. The bill would also establish an
independent Toxic Substances Board to provide
scientific advice to the Administrator of EPA.

EPA would also be given authority to collect
information on potentially toxic substances, an
authority vital to a successful program for deal-

ing with such substances. The Administrator
could request information from manufacturers
on the substances that they produce — names,
chemical identities, amounts produced, uses, and
results of tests conducted on their effects.

SUMMARY

Existing legal authorities are inadequate to
deal with toxic substances. If a substance is
toxic, control must often be exercised at the
point of manufacture and distribution because
the variety of ways in which such substances
enter the environment and the difficulties of
detecting many of them make effluent controls
an ineffective mechanism. Also, standard-
setting, monitoring, and control can often be
done more efficiently and rationally if attention
is focused on the particular substance rather
than on the medium in which it may appear.

The proposed Toxic Substances Control Act
represents a significant step in dealing with
problems that will become increasingly acute
unless action is taken. The growing number and
amount of substances produced commercially
are an en\'ironmental problem of potentially
great magnitude. The proposed legislation and
accompanying administrative action would
protect the public and the environment to a far
greater degree than is now possible.

786

References

(1) Abelson, P.H. 1970. Methyl Mercury. Editorial.

Science 169:3942.

(2) American Chemical Society, Chemical Abstracts

Service. Information provided to the Council.
(5) Athanassiadis. Y.C. 1969. Preliminary Air Pollu-
tion Survey of Cadmium and Its Compounds:
A Literature Review. Prepared by Lirton Sys-
tems, Incorporated under Department of
Health, Education, and AVelfare, Public Health
Service, Consumer Protection and Environ-
mental Health Service, National Air Pollution
Control Administration contract No. PH 22-68-
25.

(4) Athanassiadis, Y.C. 1969. Preliminary Air Pollu-

tion Survey of Vanadium and Its Compounds:
A Literature Review. Prepared by Litton Sys-
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Education, and Welfare. Public Health Service,
Con.sumer Protection and Environmental Health
Service. National Air Pollution Control Admin-
istration contract No. PH 22-68-25.

(5) Carroll, R E. 1966. The Relationship of Cadmium

in the Air to Cardiovascular Disease Death
Rates. Journal of the American Medical Asso-
ciation 198 :267-269.

(6) Council on Environmental Quality. 1970. Ocean

Dumping — A National Policy.

(7) Darby, J.R, and J.K. Sears. 1968. Plasticizers.

pp. 720-789. In Encyclopedia of Chemical Tech-
nology. 2d ed. Vol. 15.
(S) Darnay. A., and W.E. Franklin. 1969. The Role of
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Protection and Environmental Health Service,
Environmental Control Administration, Bureau
of Solid Waste Management contract No. PH
86-67-114.

(9) Duke. T.W., Lowe, J.I., and A.J. Wilson. 1970. A
Polychlorinated Biphenyl (Aroclor 1254®) in
the Water, Sediment, and Biota of Escambia
Bay, Florida. Bulletin of Environmental Con-
tamination & Toxicology 5 :171-180.
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Surface Waters of the United States, October
1970. Department of the Interior, Greological
Survey Circ. No. 643.

(11) Environmental Protection Agency, Air Pollution

Control OflSce. 1971. Information provided to
the Council.

(12) GilfiUan, S.C. 1965. Lead Poisoning and the Fall

of Rome. Journal of Occupational Medicine
7:53-60.

(13) Gleason, M.N., Gosselin, R.E., Hodge, H.C., and

R.P. Smith. 1969. Clinical Toxicology of Com-
mercial Products. 3d ed.

(14) Hauser, T.R. 1971. Plasticizers in the Environ-

ment, (mimeograph)

(15) Heath, R.G., Spann. J.W.. Kreitzer, J.F.. and

C. Vance. 1971. Effect.s of Polychlorinated
Biphenyls on Birds. In Proceedings XV Inter-
national Ornithological Congresa The Hague.
August 30-September 5, 1970. (in press)

(16) Illinois Institute of Technology Research Insti-

tute. 1967. The Cost of Clean Water. Volume
III, Industrial Waste Profile No. 10— Plastics
Materials and Resins. Prepared under Depart-
ment of the Interior, Federal AVater Pollution
Control Administration contract No. 14-12-104:

(17) Jemelov, A. 1969. Conversion of Mercury Com-

pounds, pp. 68-74. In Miller, M.M., and G.G.
Berg (eds.). Chemical Fallout: Current Re-
search on Persistent Pesticides.

(18) Johnels, A.G., and T. Westermark. Mercury Con-

tamination of the Environment in Sweden,
pp. 221-241. In Miller, M.M., and G.G. Berg
(eds.). Chemical Fallout : Current Research on
Persistent Pesticides.

(19) Klein, C.L. 1970. Testimony Before the Senate

Committee on Commerce, Subcomnuit*ee on En-
ergy. Natural Resources, and Environment
July 30.

(20) Landner, L., and A. Jemelov. 1969. Cadmium in

Aquatic Systems, pp. 47-55. In Metals and
Ecology, a symposium, Stockholm, March 24.
Swedish Natural Science Research Council.
Ecological Research Committee Bull. No. 5.
(mimeograph)

(21) Larsson, J.E. 1970. Environmental Mercury Re-

search in Sweden. Swedish Environment Pro-
tection Board, Research Secretariat, (mimeo-
graph)

(22) Little. Arthur D., Inc. 1970. The Relationship

Between Organic Chemical Pollution of Fresh
Water and Health: State-of-the-Art Study.
Prepared for Department of the Interior, Fed-
eral Water Quality Administration under con-
tract No. 14-12-538.

(23) Lutz, G.A., Levin, AA.. Bloom, S.G.. Nielsen,

K.L., Gross, J.L., and D.L. Morrison. 1970.
The Technical, Intelligence, and Project Infor-
mation System for the Environmental Health
Service. Volume III. Lead Model Case Study.
Prepared by Battelle Memorial Institute under

787

Department of Health. Education, and Welfare,
Public Health Service, Environmental Health
Service contract No. CPS-69-(X)5.
(2^) Lutz. G.A., Gross. S.B., Boatman, J.B., Moore,
P.J.. Darby, R.L.. Veazie, W.H., and F.A.
Butrico. 1967. Design of an Overview System
for Evaluating the Public-Health Hazards of
Chemicals in the Environment. Volume I. Test-
Case Studies. Final Report. Prepared by Bat-
telle Memorial Institute under Department of
Health, Education, and Welfare, Public Health
Service contract Xo. PH-86-66-165.

(25) McKee, J.E., and H.W. Wolf (eds.). 1963. Water

Quality Criteria. 2d ed. California State Water
Quality Control Board Pub. Xo. 3-A.

(26) Middleton, F.M. 1959. Report on the Recovery

of Orthonitrochlorobenzene from the Missis-
sippi River. Deijartment of Health. Education,
and Welfare. Public Health Service, Bureau of
State Services. Division of Sanitary Engineer-
ing Services, Robert A. Taft Sanitary Engineer-
ing Center, Cincinnati, (mimeograph)

(27) Miner, S. 1969. Preliminary Air Pollution Survey

of Barium and Its Comixiunds: A Literature
Re\iew. Prepared by Litton Systems, Incor-
porated under Department of Health. Educa-
tion, and Welfare. Public Health Service,
Consumer Protection and Environmental Health
Service, Xational Air Pollution Control Admin-
Lstration contract Xo. PH 22-68-25.

(28) Murozumi, M.. Chow, T.J.. and C. Patterson.

1965. Concentrations of Common Lead in Green-
land Snows, pp. 2ia-215. In Schink. D.R., and
J.T. Corless .teds.). Marine Geochemistry:
Proceedings of a Sympo.iium Held at the Uni-
versity of Rhode Island October 29 & 30. 1964.
University of Rhode Island, Graduate School
of Oceanography. Xarragansett Marine Labora-
tory Occasional Ptib. Xo. 3.

(29) Xilsson. R. 1969. Aspects on the Toxicity of

Cadmium and Its Compounds: A Review.
Swe<lish Xatural Science Research Council.
Ecological Research Committee Bull. Xo. 7.
( mimeograph )

(SO) Potts, C.L. 1965. Cadmium Proteinuria — The
Health of Battery Workers Exposed to Cad-
mium Oxide Dust Annals of Occupational Hy-
giene 8:55-61.

(31) Price, H.A. 1970. Occurrence of Polychlorinated
Biphenyls in Humans. Presented at a Presi-
dent's Cabinet Committee on the Enrtronment
Subcommittee on Pesticides meeting, Patuxent

Wildlife Research Center, Laurel, Maryland!
May 22. (abstract, mimeograph) |

(32) Pringlp. B.H.. Hissong. D.E.. Katz, E.L., anfi
S.T. Mulawka. 1968. Trace Metal Accumulatio i
by Estuarine Mollusks. Journal of the San -
tary Engineering Division 94 :4o5-475. Xo. SA' ,
Proceedings of the American Society of Civil
Engineers Paper Xo. 5970.

(.iS) Schroeder. H.A. 1970. Trace Elements in the Hu-
man Environment. Entered into the record of
the Senate Committee on Commerce, Subcom-
mittee on Energy, Xatural Resources, and
Environment. August 27.

(3.i) Schroeder. H.A. 1965. Cadmium as a Factor in
Hypertension. Journal of Chronic Diseases
18 :647-656.

(35) Schroeder. H.A. undated. Vanadium in Man and

His Environment. Air Quality Monograph Xo.
2. (mimeograph)

(36) Soap and Detergent Association. 1971. Informa-

tion provided to the Council.

(37) Steinfeld. J.L. 1970. Testimony Before the Senate

Committee on Commerce, Subcommittee on
on Energy, Xatural Resources, and Environ-
ment. August 27.

(38) Stokinger. H.E. 1969. The Swctre of Today's En-

vironmental Pollution— USA Brand: Xew
Perspectives from an Old Scout. American In-
dustrial Hygiene Association Journal 30:195-
217.

(39) Sullivan, R.J. 1969. Preliminary Air Pollution

Survey of Arsenic and Its Compounds : A Lit-
erature Re^^ew. Prepared by Litton Systems,
Incorporated under Department of Health. Edu-
cation, and Welfare. Public Health Service,
Consumer Protection and Environmental
Health Service, Xational Air Pollution Con-
trol Administration contract Xo. PH 22-68-25.

(40) Taggart, A.F. 1945. Handbook of Mineral Dres-

sing, Ores, and Mineral Industries.
(il) U.S. Department of Commerce. 1971. U.S. In-
dustrial Outlook 1971 with Projections Through
1980.

(42) U.S. Department of Commerce. 1971. Information

provided to the Council.

(43) U.S. Department of Health. Education, and Wel-

fare. 1971. Information provided to the Council.

(44) U.S. Department of the Interior. Bureau of

Mines. 1969. Minerals Yearbook 196S: Vol-
ume I-II, Metals. Minerals, and Fuels.

(45) U.S. Department of the Interior. Bureau of

Mines. 1949. Minerals Yearbook 1948.

788

(46) U.S. Department of the Interior, Federal Water

Pollution Control Administration. 1970. The
National Estuarine Pollution Study.

(47) U.S. Tariff Commission. 1970. Synthetic Organic

Chemicals : United States Production and Sales,
1968. T.C. Pub. No. 327.

(48) U.S. Tariff Commission. 1970. U.S. Production

and Sales of Dyes Increased in 1969. Public In-
formation. October 23.

(49) U.S. Tariff Commission. 1963. Synthetic Organic

Chemicals: United States Production and
Sales, 1962. T.C. Pub. No. 114.

APPENDIX II

BIBLIOGRAPHY— CONGRESSIONAL DOCUMENTS

1971-1976

Note. — Documents reproduced in this legislative history are indicated by an
asterisk (*).

79-313 O - 77 - 51

BIBLIOGRAPHY

92d Congress

PBOPOSAL

*U.S. Council on Environmental Quality. Toxic substances. Washington, For sale
by the Supt. of Docs., U.S. Govt. Print. Offi. 1971. 25 p.

•'The shortcomings of the legal authorities described above, the effects of
toxic substances outlined in Chapter II, their increasing number and
amounts indicated in Chapter I, and the inadequate attention paid to such
substances all support the need for a new legal and institutional system to
deal with toxic substances."
Bibliography : p. 23-25.

HEARINGS

U.S. Congress. House. Committee on Interstate and Foreign Commerce. Subcom-
mittee on Commerce and Finance. Toxic Substances Control Act. Hearings,
92d Cong., 2d sess., on H.R. 5276 (and identical bills) and H.R. 10840 (and
identical bills). May 18 and 23, 1972. Washington, U.S. Govt. Print. Off., 1972.
199 p. "Serial No. 72-73"

U.S. Congress. Senate. Committee on Commerce. Subcommittee on the Environ-
ment. The Toxic Substances Control Act of 1971 and amendment. Hearings,
92d Cong., 1st sess., on S. 1478. Washington, U.S. Govt. Print. Off., 1972. 3 v.
(1251 p.)

Part I contains discussions on mercury, polychlorinated biphenyls, and a
National Research Council report on airborne asbestos. Parts II and III
contain discussions and materials on phosphate detergents and NTA-based
detergents. Part 3 also reprints "The Eutrophication problem : a review and
critical analysis ; the non-role of detergent phosphates in eutrophication,"
p. 864-898.

REPORTS

U.S. Congress. House. Committee on Interstate and Foreign Commerce. Toxic
Substances Control Act of 1972; report to accompany S. 1478. Washington,
U.S. Govt. Print. Off. 1972. 26 p. (92d Cong., 2d sess. House. Report No.
92-1477)

U.S. Congress. Senate. Committee on Commerce. Toxic Substances Control Act
of 1972; report on S. 1478 together with supplemental views. Washington,
U.S. Govt. Print. Off., 1972. 37 p. (92d Cong., 2d sess. Senate. Report No.
92-783)

DEBATES

Senate considered and passed S. 1478, May 30, 1972 : Congressional Record, Vol.

118, part 15, pp. 19156-19174.
House considered and passed S. 1478, amended, October 30, 1972 : Congressional

Record. Vol. 118, part 27, pp. 36054-36065.
Senate considered and passed S. 1478 as amended, with amendments, October 14,

1972 Congressional Record, Vol. 118, part 27, pp. 36054-36065.
House — objection heard to motion to consider S. 1478, as amended, October 17,

1972: Congressional Record, Vol. 118, part 28, pp. 36967-36968.

93rd Congress

HEARINGS

U.S. Congress. House. Committee on Interstate and Foreign Commerce. Subcom-
mittee on Commerce and Finance. Toxic substances control legislation---1973^
Hearings, 93d Cong., 1st sess., on H.R. 5087, H.R. 5356, and H.R. 1014. Mar. lo
and 16, 1973. Washington, U.S. Govt. Print. Off., 1973. 386 p.

United States Congress. Senate. Committee on Commerce. Subcommittee on tne
Environment. Toxic substances control act of 1973. Hearings, Ninety-third
Congress, first session, on S. 426 and Amendments 1, 8, and 9 . . . and
S. 888 .. . February 23, 26, and March 21, 1973. Washington, U.S. Govt. Print.
Off., 1973. iv, 397 p. illus. 24 cm.

, (791) ,

792

REPORTS

U.S. Congress. House. Committee on Interstate and Foreign Commerce. Toxic
Substances Control Act of 1973; report together with dissenting and supple-
mental views on H.R. 5356. Washington, U.S. Govt. Print. Off., 1973. 76 p.
(93d Cong., 1st sess. House. Report No. 93-360)

U.S. Congress. Senate. Committee on Commerce. Toxic Substances Control Act
of 1973; report ... on S. 426 together with additional views. Washington,
U.S. Govt. Print. Off., 1973. 64 p. (93d Cong., 1st sess. Senate. Report No.
93-254)

DEBATES

Senate considered and passed S. 426, July 18, 1973 : Congressional Record, Vol.

119, part 19, pp. 24485-24501.
House considered and passed S. 426, amended, in lieu of H.R. 5356, July 23, 1973 :

Congressional Record, Vol. 119, part 20, pp. 25430-25476.

94th Congress

HEARINGS

U.S. Congress. House. Committee on Interstate and Foreign Commerce. Subcom-
mittee on Consumer Protection and Finance. Toxic Substances Con|;rol Act.
Hea-ings, 94th Cong., 1st sess., on H.R. 7229, H.R. 7548, and H.R. 7664. Wash-
ingt'^n, U.S. Govt. Print. Off., 1975. 482 p. Hearings held June 6 . . . July 11,
197:. "Serial No. 94-41"

U.S. » ngress. Senate. Committee on Commerce. Subcommittee on the Environ-
ment. Toxic Substances Control Act. Hearings, 94th Cong., 1st sess., on S. 776.
Wa? ington, U.S. Govt. Print. Off., 1975. 362 p. Hearings held Mar. 3 . . .
Apr. .5, 1975. "Serial No. 94-24"
-U.S Congress. Senate. Committee on Commerce. Subcommittee on the Environ-
ment. Toxic Substances Control Act. Hearing, 94th Cong., 1st sess., on S. 776.
Oct. 24, 1975. Part 2. Washington, U.S. Govt. Print. Off., 1976. 154 p. "Serial
No. 94-24"

REPORTS

♦U.S. Congress. House. Committee on Interstate and Foreign Commerce. Toxic
Substances Control Act; report together with supplemental and minority
views (including cost estimate of the Congressional Budget OflSce) to accom-
pany H.R. 14032. Washington, U.S. Govt. Print. Off., 1976. 141 p. (94th Cong.,
2d sess. House. Report No. 94-1341)

♦U.S. Congress. Senate. Committee on Commerce. Toxic Substances Control Act;
report on S. 3149 together with additional views. Washington, U.S. Govt. Print.
Off., 1976. 90 p. (94th Cong., 2d sess. Senate. Report No. 94-698)

"To regulate commerce and protect human health and the environment
by requiring testing and necessary use restrictions on certain chemical
substances, and for other purposes."

♦U.S. Congress. Conference Committee, 1976. Toxic Substances Control Act;
conference report to accompany S. 3149. Washington, U.S. Govt. Print. Off.
1976. 105 p. (94th Cong., 2d sess. House. Report No. 94-1679)

U.S. Congress. Conference Committee, 1976. Toxic Substances Control Act;
conference report to accompany S. 3149. Washington, U.S. Govt. Print. Off.
1976. 105 p. (94th Cong., 2d sess. Senate. Report No. 94-1302)

DEBATES

♦Senate considered and passed S. 3149, March 26, 1976 : Congressional Record,

Vol. 122, pp. S4397-S4432 [daily ed.].
♦House considered and passed S. 3149, amended, in lieu of H.R. 14032, August 23,

1976: Congressional Record, Vol. 122, pp. H8803-H8863 [daily ed.].

♦Senate agreed to conference report, Sept. 28, 1976: Congressional Record, Vol.
122, pp. S16808-S16810 [daily ed.] ; also, October 1, 1976, pp. S17596-S17597
[daily ed.].

♦House agreed to conference report, Sept. 28, 1976: Congressional Record, Vol.
122, pp. H11343-H11348 [daily ed.].

SECTION-BY-SECTION INDEX

Notes oil the use of the index —

1. The index is preceded by a comparison of the sections of P.L. 94-469,
H.R. 14032, and S. 3149; the index follows the same order of sections as the
comparison.

2. A dash ( — ) in place of a section number indicates "No Comparable
Provision."

3. Bold figures in the index denote particularly significant references.

SECTIOX-BY-SECTION INDEX

TABLE l.-COMPARISON OF SECTIONS OF PUBLIC LAW 94-469, H.R. 14032, AND S. 3149

coMinn . H-R. 14032 H.R. 14032 S 3149 S 3149

Law 94-469 as passed as reported as passed as reported

Short title and table of contents 1 1 i i i

Findings, policy, and intent 2 ? o k \

Definitions.. 3 3^??

T esting of chemical substances and mixtures 4 4 4 4^

Manufacturing and processing notices 5 5 S ^ t

Regulation of hazardous chemical substances and" ^ d b

mixtures.. 6 6 6 fi c

imminent hazards 7 7 7 7 7

Reporting and retention of information 8 8 8 « o

Relationship to other Federal laws 9 9 9 9 0

Research, development, collection, dissemination,

and utilization of data 10 lo lo in in

Inspections and subpoenas... 11 n ii jV |,

Exports 12 12 12 lo },

Entry into customs territory of the United States. 13 13 13 13 \\

Disclosure of data 14 14 li ij }i

Prohibited acts 15 5 15 J ?

Penalties 16 le le 6 6

Specific enforcement and seizure 17 17 17 17 (7

Preemption. ig ig is 18 18

Judicial review 19 19 jg in

Citizens' civil actions 20 20 20 20 20

Citizens' petitions 2I 21 21 21 21

National defense waiver 22 22 22 22 22

Employee protection.. 23 23 23 23Ial 23Ia)

Employment effects 24 24 24 23 23

Studies 25 25 25 24 24

Administration of the act 26 26 26 26 25

Development and evaluation of test methods 27 27 27

State programs. 28 28 25

Sunshine in government ... 29

Authorization for appropriations. 29 30 28 27 26

Annual report 30 31 29 28 27

Rule review 32

Effective date 31 33 30

Section 1: Short Title a2\d Tabij: of Contents

Page

Toxic Substances Control Act 3

S. 3149 57-58

Senate Report Xo. 1)4-698 170

Senate debate 264

H.R. 14032 297-298

House Report No. 94-1341 416

House debate r^42, 629-630

Section 2 : Findings, Policy, and Intent

Toxic Substances Control Act 3-4

S. 3149 58-60

Senate Report Xo. 94-698 166, 170, 190, 200, 203

Senate debate 264-26.')

H.R. 14032 298-300

House Report Xo. 94-1341 416-417, 474, 483-484, 487

House debate 540, 542-543. 630

Conference report 668-669

House consideration of confeience report 792-743

(795)

796

Section 3: Definitions

Toxic Substances Control Act 4-6

S. 314<) 60-65

Senate Report No. l)4-(;98 , 170-171, 190-191, 194-196, 204

Senate debate 220-221, 231-233, 253, 265-26H

H.R. 14032 300-304

House Report No. 94-1341 _ 417-423. 4r)2, 474-475, 478-480, 487, 488-489, 491-492, 503

House del ate 523-r)24, 540, 543-r)44, 544-552, 552-557, 630-632

Conference report 669-670, 685, 708

Senate consideration of conference report 726

Section 4: Testing of Chemical Substances and Mixtures

Toxic Substances Control Act 6-12

S. 3149 , 65-81

Senate Report No. 94-698 158,162-163,166,169,171-173,191,196,204,205-206

Senate debate 208, 227, 247, 252, 254, 266-271

H.R. 14032 304-319

House Report No. 94-1341 421-422,

424-429, 430, 432, 435, 450, 454, 456, 457, 459, 461, 462, 463, 46-1^66,

-I()7, 468, 469, 475, 480, 485, 487, 489, 492-494, 500, 510, 513
House debate 518,

524. 529, 540, 545-546, 557-561, 562-569, 590, 609, 610, 625-626, 632-

63()

Conference report 671-675,

()76, 67{>-680, 692, (593. 696, 701, 704, 704-705, 706-707, 707, 708-709,
710, 710-712, 714-715, 718

Senate consideration of f'onference rep(,rt 722-723,725, 726,730,732

House consideration of conference report 747, 749

Section 5: Manufacturing and 1'kocessing Notices

Toxic Substances Control Act ' 12-20

S. 3149 - 81-92

Senate Report No. 94-698 157, 163-164, 166-167, 168, 173-175, 191, 196-197

Senate debate , 208, 227, 252, 262, 271-274

H.R. 14032 320-338

House Report No. 94-1341 421-423,

429-438, ^50, 451, 456, 457. 4.59, -160. 461, 462, 463, 464-466, 467, 468,
469, 475, 480-481, 485, 489, 490, 494-495, .500, 511-514
House debate i ^1^'

520. 523, 524, 532, 538, 540, 541, 544-552, 552-557, 569-574, 574-575,
625-626, 636-641

Conference report

672, 675, 675-685, 692. 693-()94, 69(), 700, 701, 704, 704-705, 706-707,
707, 708-709, 710, 710-712, 714-715, 718

Senate consideration of conference report 722, 723-725, 730, 733, 740-741

House consideration of coJiference report 743, 748, 749

Section 6: Ri-:GrEATioN of Hazardous Chemical Substances and Mixtures

Toxic Substances Control Act

S. 3149 92-108

Senate Report No. 94-698

164, 166, 168, 169, 17&-177, 188, 191-192, 197-198

Senate debate 212, 222, 227, 233-240, 240-242-243, 252, 255, 274-279

H.R. 14032 338-349

House Report No. 94-1341 422,

434, 439-447, 447-448, 450, 453, 456, 459, 460, 461, 462, 463, 464-466,
467, 469, 475-476, 481-482, 489-490, 495, 500, 503, 508-509, 511-512,
513 _
House debate - 51?'

521, 540, 554-557, 575-578, 579, 579, 580-590, 609, 623, 625-626,
641-645

707

Conference report _ __ g^Q

672, 675, 676, 682, 683, 684, 685, 685-690, 690, "691," "^2" "693 695*
697, 701, 7(>i-705, 705, 706-707, 707, 708-709, 710, 710-712, 713, 718

Senate consideration of conference report '724

726, 727, 728-730, 723^725, 730~ 733, 740-741

House consideration of conference report 742, 743-744, 748-749, 753-754

Section 7 : Imminent Hazabds

Toxic Substances Control Act _ __ _ 26-27

S. 3149 ""1O8-III

Senate Report No. 94-698 177, igg, 204

Senate debate 252 27^280

H.R. 14032 . i 349-353

House Report No. 94-1341 446,

447-448, 450, 453, 456, 459, 480-481, 4~82, 487, 503

House debate 540, 590-591, 645-646

Conference report 669,

672, 675, 684, 687, 689, 690-691, 694, 695, 697, 701
Senate consideration of conference report 726

Section 8 : Reporting and Retention of Information

Toxic Substances Control Act 27-30

S. 3149 111-116

Senate Report No. 94-698 164, 177-179, 192, 198-199

Senate debate 209. 252-253, 280-281

H.R. 14032 353-360

House Report No. 94-1341 421,

430, 448-452, 455. 469, 476, 482-483, 490, 490-491, 495-498

House debate 521, 523, 539-540, 540. 552-557, 591.-593, 647-648

Conference report 669. 671, 680, 691-694, 696. 700. 708. 711-712

Senate consideration of conference report 723-724, 726, 732

House consideration of conference report 742

Section 0 : Relationship to Other Federal Laws

Toxic Substances Control Act 30-31

S. 3149 - - > 116-120

Senate Report No. 94-698 . 158. 164-165, 167, 179, 193, 199, 200

Senate debate 227. 2.5.3. 281-283

H R 140.32 360-364

House Report ~Xo.~04^Y34Y_AV_V4y2^54^ 477^78', 483, 483-484, 491, 498-499, 503-504

House debate . 59.3-595, ^J>-650

Conference report ' 557??

House consideration of conference report 744-745

Section 10: Research, Development. Collection, Dissemination, and Utili-
zation OF Data

Toxic Substances Control Act ■ ^on^To?

S. 3149 - 120-1^1

Senate Report No.' 94-698 ^'^"ofS'o^

Senate debate il^'

H R 1 40S2 _ • 004— ODD

House Repoir<;^~9i:i^ii:::::::::::::::::

Hou.se debate ^^^-fj'df.

Conference report bys-/uu

Section 11 : Inspections and Subpenas

Toxic Substances Control Act '"""7oi ioq

O 0140 1^1-1^0

J5. OX'±if nft-j

Senate Report No. 94-698 '>^l284

Senate debate

H.R. 14032 3^^^^^

798

House Report Xo. 94-1341 455,485,500-502,503,513

House debate 595,623,651

Conference report 700-701, 705

Section 12 : Exports
Toxic Substances Control Act 33-34

S. 3149 ::;"i23-i24

Senate Report No. 94-698 180-181

Senate debate 984

H.R. 14032 367-369

House Report No. 94-1341 % 455-456

House debate 596,651

Conference report 701

Section 13: Entry Into Customs Territory of the United States

Toxic Substances Control Act _ 35

S. 3149 124-126

Senate Report No. 94-698 181, 204

Senate debate 284-285

H.R. 14032 369-370

House Report No. 94-1341 456, 487-488, 507

House debate 596, 652

Conference report 701-702

Section 14 : Disclosure of Data

Toxis Substances Control Act 34-36

S. 3149 126-127

Senate Report No. 94-698 181, 192-193, 201-203, 205

Senate debate 253, 285

H.R. 14032 1 370-374

House Report No. 94-1341 432, 433, 456,-459, 476-477, 485-48«, 516

House debate 533-534, 597, 652-653

Conference report 671, 672, 680, 681, 701, 702-704

Senate consideration of conference report 730

Section 15 : Prohibited Acts

Toxic Substances Control Act 36

S. 3149 127

Senate Report No. 94-698 181

Senate debate 234, 285

H.R. 14032 374-375

House Report No. 94-1341 459

House debate 598, 653

Conference report 704-705, 705, 706, 707

Section 16 : Penalties

Toxic Substances Control Act 37

S. 3149 128-130

Senate Report No. 94-698 182

Senate debate 285-286

H.R. 14032 375-378

House Report No. 94-1341 459-460

House debate 598-599, 623, 653-654

Conference report 705-706

Senate consideration of conference report 726

Section 17: Specific Enforcement and Seizure

Toxic Substances Control Act 37-38

S. 3149 130-132

Senate Report No. 94-698 182

Senate debate 257-262, 286

799

H.R. 14032 q7«ocn

House Report No. 94-1341 4601461" ^2 503

House debate___ 59^' g-^^

Conference report 70&-707

Section 18 : Preemption

Toxic Substances Control Act 38-39

S. 3149 132-134

Senate Rei)ort No. 94-698 182-183, 193, 198, 203

Senate debate 227, 229, 255, 286-287

H.R. 14032 380-382

House Report No. 94-1341 461-642, 477, 487, 491, 502, 512-513

Hou.se debate 599-600, 625-626, 655

Conference report 707-708

Section 19: Judicial Review

Toxic Substances Control Act 39^1

S. 3149 ""134-136

Senate Report No. 94-698 183-184

Senate debate 255, 287-288

H.R. 14032 382-384

House Report No. 94-1341 446, 462-463, 502

House debate 600-601, 655-656

Conference report 708-709, 711, 714

Senate consideration of conference report 726-727, 727-730

Section 20: Citizens' Civil Action

Toxic Substances Control Act 41-42

S. 3149 136-140

Senate Report No. 94-698 159, 165, 184, 198, 203

Senate debate 209, 288-289

H.R. 14032 385-388

Hou.se Report No. 94-1341 446, 463-464, 482, 487, 515

House debate 533, 601-602, 656-657

Conference report 710

Senate consideration of conference report 727-730

Section 21 : Citizens' Petitions

Toxic Substances Control Act 42-43

S. 3149 140-142

Senate Report No. 94-698 159, 165, 168-169, 184-185

Senate debate 209, 2.53. 289

H.R. 14032 388-391

House Report No. 94-1341 466, 464-466, 515

House debate 521-522, 533, 602-603. 657-658

Conference report 710-712

Senate consideration of conference report _ 727-730

Section 22 : National Defense Waiver

Toxic Substances Control Act „ ^ ■[

S. 3149 142-143

Senate Report No. 94-698 l°o

Senate debate

H R 14032 6vi-ovz

House Report""Nor 94-1341."." 466

Hou.se debate ^'J^

Conference report

Section 23: Employee Protection

44-45

Toxic Substances Control Act i49_lifi

S. 3149...::: - Lia-i'io

800

Senate Report No. 94-698 165, 185-186

Senate debate 209, 221-226, 257, 290-291

H.R. 14032 392-395

House ReiK)rt No. 94-1341 466-467, 515

House debate 531, 533, 603-604, 658-659

Conference report 712-713

Section 24 : Employment Effects

Toxic Substances Control Act 45-46

S. 3149 (Section 23(f) of S. 3149) 146-148

Senate Report No. 94-698 (section 23(f) of S. 3149) 165, 186

Senate debate (section 23(f) of S. 3149) 209, 221-226, 291

H.R. 14032 396-398

House Report No. 94-1341 467, 515-516

House debate 531, 533, 604-605, 659-660

Conference report 713

Section 25 : Studies

Toxic Substances Control Act 46

S. 3149 (section 24 of S. 3149) 148-149

Senate Report No. 94-698 (section 24 of S. 3149) 186, 194, 203

Senate debate (section 24 of S. 3149) 291

H.R. 14032 398-399

House Report No. 94-1341 467-468, 487, 504-505

House debate 606, 660-661

Conference report 713-714

Section 26 : Administration of the Act

Toxic Substances Control Act 46-48

S. 3149 (section 25 of S. 3149 as reported) 149-152

Senate Report No. 94-698 186-187, 201, 204

Senate debate 292-293

H.R. 14032 399-402

House Report No. 94-1341 468-469, 485, 487

House debate 524, 605, 618-619, 661

Conference reiwrt 714-716

Section 27: Development and Evaluation of Test Methods

Toxic Substances Control Act 49

H.R. 14032 402-403

House Report No. 94-1341 469-470

House debate 522, 524, 606, 661-662

Conference report 716

Section 28 : State Programs

Toxic Substances Control Act 49-50

Senate debate (section 25 of S. 3149) 227-230, 291-292

House debate 616-618, 662-663

Conference report 716-717

Section — : Sunshine in Government

(Section 29 of H.R. 14032 as passed)

House debate 619-622, 663

Conference report '715

Section 29 : Authorization for Appropriations

Toxic Substances Control Act 50

S. 3149 (Section 26 of S. 3149 as reported) 152-153

Senate Report No. 94-698 (.section 26 of S. 3149 as reported) 187,

188, 189, 194, 203

801

Senate debate (section 27 of S. 3149 as passed) 293

H.R. 14032 (section 28 of H.R. 14032 as reported) _"_ 403-404

House Report No. 94-1341 (section 28 of H.R. 14032 as reported) 416

470, 471-472, 478, 4~87, 50~5^06, 513

House debate 606, 623-624, 624, 663

Conference reiwrt 717

House consideration of conference report 742

Section 30: Annual Report

Toxic Substances Control Act 50-51

S. 3149 (section 27 of S. 3149 as reported) 153-154

Senate Report No. 94-698 (section 27 of S. 3149 as reported) 187

Senate debate (section 28 of S. 3149 as passed) 293-294

H.R. 14032 (section 29 of H.R. 14032 as reported) 404-405

House Report No. 94-1341 (section 29 of H.R. 14032 as reported) 470, 506

House debate (section 29 of H.R. 14032 as reported) 606-607, 663

Conference report 718

Section — : Rule Review

( Section 32 of H.R. 14032 as passed)

House debate 607-616, 664

Conference report 718

House consideration of conference report 745-746

Section 31 : Effective Date

Toxic Substances Control Act 51

H.R. 14a32 (section 30 of H.R. 14032 as reported) 405

House Report No. 94-1341 (section 30 of H.R. 14032 as reported) 470

House debate (section 30 of H.R. 14032 as reported) 607, 664

Conference report 718

House consideration of conference report 742

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Full text of "Legislative history of the Toxic Substances Control Act, together with a section-by-section index"

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